Home 
How Blumble Works 
Search Algorithm 
Your Privacy 
About 
Facebook
Twitter
Blog
Most recent job postings at Endpoints News
via Endpoints Careers
schedule_type: Full-time
COMPANY:
Centessa Pharmaceuticals plc (Nasdaq: CNTA) new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. Centessa is advancing a portfolio of high conviction programs with strong biological validation...
Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal
COMPANY:
Centessa Pharmaceuticals plc (Nasdaq: CNTA) new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. Centessa is advancing a portfolio of high conviction programs with strong biological validation...
Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation. Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs.
SUMMARY:
As we continue to grow, we are seeking a (Sr) Director, Regulatory CMC. The (Sr.) Director, Regulatory CMC will assist in defining strategy and assist (when necessary) with execution for our companies working with our seven large molecule programs (antibodies and peptide/protein expression). The Regulatory (Sr.) Director will have the knowledge of CMC processes (and regulatory requirements) and have a solid understanding of the duration, timing and execution of required activities. The objective is to guide and assist our programs in order of execution such that preventable delays waiting for CMC deliverables are avoided.
RESPONSIBILITIES:
• Identification and resolution of technical challenges in the areas of drug substance process development and manufacturing, drug product formulation development, drug product process development, manufacturing, and packaging, analytical method development, and technology transfer
• Creation and execution of CMC development plans for new products; ability to manage regulatory submissions and project manage these submissions with the Technical Operations team and associated CMOs
• Assistance in the creation and execution of process (drug substance and drug product) and analytical method validation plans
• Coordination with supply chain and clinical operations groups for production of clinical trial materials
• Assistance in batch record review, as required
• Assistance in deviation investigations, as required (assess regulatory impact for deviations and change controls)
• Assistance in the writing, preparation, and review of regulatory documentation
• Assistance in due diligence technical assessments of potential new products
QUALIFICATIONS:
• Thorough understanding of cGMP requirements for pharmaceutical products
• Strong organizational, analytical and interpersonal skills
• Ability to work independently in a fast-paced dynamic environment with multiple projects
• Demonstrated ability to coordinate CMO activities in the development and commercialization of pharmaceutical products
• Strong decision-making and analytical skills
• Excellent organizational skills, project management skills and detail-orientated leadership approach
EXPERIENCE:
• MS or Ph.D. in chemistry, pharmaceutical sciences, or related field preferred
• 5-7 years of direct experience with pharmaceutical product development
• Experience in sterile fill/finish of drug product for clinical studies
• Experience in Supply Chain requirements and timing (packaging/labeling is a plus but not mandatory as well as a deep understanding of GMP regulations)
• Must have experience working with CMOs and a solid knowledge of analytical method development/validation
POSITION: Full-Time, Exempt
EEOC Statement: Centessa Pharmaceuticals believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law Show more details...
Centessa Pharmaceuticals plc (Nasdaq: CNTA) new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. Centessa is advancing a portfolio of high conviction programs with strong biological validation...
Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation. Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs.
SUMMARY:
As we continue to grow, we are seeking a (Sr) Director, Regulatory CMC. The (Sr.) Director, Regulatory CMC will assist in defining strategy and assist (when necessary) with execution for our companies working with our seven large molecule programs (antibodies and peptide/protein expression). The Regulatory (Sr.) Director will have the knowledge of CMC processes (and regulatory requirements) and have a solid understanding of the duration, timing and execution of required activities. The objective is to guide and assist our programs in order of execution such that preventable delays waiting for CMC deliverables are avoided.
RESPONSIBILITIES:
• Identification and resolution of technical challenges in the areas of drug substance process development and manufacturing, drug product formulation development, drug product process development, manufacturing, and packaging, analytical method development, and technology transfer
• Creation and execution of CMC development plans for new products; ability to manage regulatory submissions and project manage these submissions with the Technical Operations team and associated CMOs
• Assistance in the creation and execution of process (drug substance and drug product) and analytical method validation plans
• Coordination with supply chain and clinical operations groups for production of clinical trial materials
• Assistance in batch record review, as required
• Assistance in deviation investigations, as required (assess regulatory impact for deviations and change controls)
• Assistance in the writing, preparation, and review of regulatory documentation
• Assistance in due diligence technical assessments of potential new products
QUALIFICATIONS:
• Thorough understanding of cGMP requirements for pharmaceutical products
• Strong organizational, analytical and interpersonal skills
• Ability to work independently in a fast-paced dynamic environment with multiple projects
• Demonstrated ability to coordinate CMO activities in the development and commercialization of pharmaceutical products
• Strong decision-making and analytical skills
• Excellent organizational skills, project management skills and detail-orientated leadership approach
EXPERIENCE:
• MS or Ph.D. in chemistry, pharmaceutical sciences, or related field preferred
• 5-7 years of direct experience with pharmaceutical product development
• Experience in sterile fill/finish of drug product for clinical studies
• Experience in Supply Chain requirements and timing (packaging/labeling is a plus but not mandatory as well as a deep understanding of GMP regulations)
• Must have experience working with CMOs and a solid knowledge of analytical method development/validation
POSITION: Full-Time, Exempt
EEOC Statement: Centessa Pharmaceuticals believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law Show more details...
via Salary.com
schedule_type: Full-time
SUMMARY
Imaging Endpoints (IE) is an Imaging Clinical Research Organization (iCRO) that also provides comprehensive CRO and Site Management Organization (SMO) services for image-centric trials. We are...
based in Scottsdale, Arizona and are an affiliate of the Scottsdale Healthcare Network, one of the 50 largest healthcare systems nationally, and an affiliate of Scottsdale Medical Imaging Limited (SMIL), ranked as the 4th largest private radiology
SUMMARY
Imaging Endpoints (IE) is an Imaging Clinical Research Organization (iCRO) that also provides comprehensive CRO and Site Management Organization (SMO) services for image-centric trials. We are...
based in Scottsdale, Arizona and are an affiliate of the Scottsdale Healthcare Network, one of the 50 largest healthcare systems nationally, and an affiliate of Scottsdale Medical Imaging Limited (SMIL), ranked as the 4th largest private radiology group in the US. Our experience extends from translational to phase III and IV studies and every step in between.
The Imaging Specialist is primarily responsible for conducting a variety of QC/analysis procedures. This person is responsible for reviewing the imaging data received from clinical trial imaging sites/sponsors to confirm specific protocol requirements have been met as well as ensuring technical adequacy and data integrity. In additional this person will assist in project management duties within the operations department and serve as imaging technical support for internal and external staff.
RESPONSIBILITIES
• Perform technical quality review of images per trial specifications
• Perform Quantitative image analysis
• Perform Imaging data reconstruction per trial specifications
• Manage research projects and early phase clinical trials for day-day activities
• Compel quality control documentation according to standard operating procedures
• Develop quality control documentation in conjunction with the Project Manager
• Generate image queries to address technical issues, track those issues and ensure timely resolution
• Clinical site and imaging center support
• Creation and review of imaging site questionnaires
• Develop training materials for imaging site personnel
• Technical training of imaging site personnel (on-site or telecon)
• Assist in the writing of site imaging manuals
• Contribute to trial specific imaging charters as needed
• Mentor and assist in the training of internal staff
• Other duties as assigned by manager
EDUCATION AND EXPERIENCE
• Registered Technologist (R.T.) with advance modality experience in CT, MRI or Nuclear Medicine preferred.
• Minimum of 2 years of experience in medical imaging required
• Proficiency in MS Office and internet applications required
• Minimum of 1 year of experience in the clinical trials industry preferred
• Knowledge of Good Clinical Practice (GCP), Quality Assurance/Compliance in a clinical trials setting is preferred
• Knowledge of image trial documents strongly preferred; i.e. Image Review Charter, Imaging Manual, Data Transmittal Forms, etc.
• Prior Project Management duties preferred, i.e. driving timelines, deliverables and managing concurrent priorities
SKILLS
• Service oriented approach, flexible and proactive
• Must have superior attention to detail and excellent oral and written communication skills
• Self-driven, ability to get the job done with little supervision, can-do positive attitude
• Ability to excel in a team environment
• Must have the ability to work under pressure with multiple competing priorities
• Must have strong time management, and organizational skills.
• Prioritizing workload to the changing needs of the day to day business is also a critical skill.
• Ability to work in strict compliance with all procedures, rules and regulations
• Maintain strict confidentiality of sensitive data, records, files, conversations, etc.
• Must be self-motivated and able to grasp new concepts quickly
• Project Management Skills preferred
• Ability develop and drive project timelines
• Ability to motivate others and keep project teams working effectively
• The ability to communicate clearly, concisely and frequently and know when to use email, schedule meetings or conduct one-on-one conversations
• Possess the skills required to keep senior leadership informed to support business making decisions
PHYSICAL REQUIREMENTS
While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk and hear. The employee is frequently required to sit. Specific vision abilities required by this job include close vision, color vision, ability to adjust focus.
TRAVEL
Up to 10-15%% both domestic and international Show more details...
Imaging Endpoints (IE) is an Imaging Clinical Research Organization (iCRO) that also provides comprehensive CRO and Site Management Organization (SMO) services for image-centric trials. We are...
based in Scottsdale, Arizona and are an affiliate of the Scottsdale Healthcare Network, one of the 50 largest healthcare systems nationally, and an affiliate of Scottsdale Medical Imaging Limited (SMIL), ranked as the 4th largest private radiology group in the US. Our experience extends from translational to phase III and IV studies and every step in between.
The Imaging Specialist is primarily responsible for conducting a variety of QC/analysis procedures. This person is responsible for reviewing the imaging data received from clinical trial imaging sites/sponsors to confirm specific protocol requirements have been met as well as ensuring technical adequacy and data integrity. In additional this person will assist in project management duties within the operations department and serve as imaging technical support for internal and external staff.
RESPONSIBILITIES
• Perform technical quality review of images per trial specifications
• Perform Quantitative image analysis
• Perform Imaging data reconstruction per trial specifications
• Manage research projects and early phase clinical trials for day-day activities
• Compel quality control documentation according to standard operating procedures
• Develop quality control documentation in conjunction with the Project Manager
• Generate image queries to address technical issues, track those issues and ensure timely resolution
• Clinical site and imaging center support
• Creation and review of imaging site questionnaires
• Develop training materials for imaging site personnel
• Technical training of imaging site personnel (on-site or telecon)
• Assist in the writing of site imaging manuals
• Contribute to trial specific imaging charters as needed
• Mentor and assist in the training of internal staff
• Other duties as assigned by manager
EDUCATION AND EXPERIENCE
• Registered Technologist (R.T.) with advance modality experience in CT, MRI or Nuclear Medicine preferred.
• Minimum of 2 years of experience in medical imaging required
• Proficiency in MS Office and internet applications required
• Minimum of 1 year of experience in the clinical trials industry preferred
• Knowledge of Good Clinical Practice (GCP), Quality Assurance/Compliance in a clinical trials setting is preferred
• Knowledge of image trial documents strongly preferred; i.e. Image Review Charter, Imaging Manual, Data Transmittal Forms, etc.
• Prior Project Management duties preferred, i.e. driving timelines, deliverables and managing concurrent priorities
SKILLS
• Service oriented approach, flexible and proactive
• Must have superior attention to detail and excellent oral and written communication skills
• Self-driven, ability to get the job done with little supervision, can-do positive attitude
• Ability to excel in a team environment
• Must have the ability to work under pressure with multiple competing priorities
• Must have strong time management, and organizational skills.
• Prioritizing workload to the changing needs of the day to day business is also a critical skill.
• Ability to work in strict compliance with all procedures, rules and regulations
• Maintain strict confidentiality of sensitive data, records, files, conversations, etc.
• Must be self-motivated and able to grasp new concepts quickly
• Project Management Skills preferred
• Ability develop and drive project timelines
• Ability to motivate others and keep project teams working effectively
• The ability to communicate clearly, concisely and frequently and know when to use email, schedule meetings or conduct one-on-one conversations
• Possess the skills required to keep senior leadership informed to support business making decisions
PHYSICAL REQUIREMENTS
While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk and hear. The employee is frequently required to sit. Specific vision abilities required by this job include close vision, color vision, ability to adjust focus.
TRAVEL
Up to 10-15%% both domestic and international Show more details...
via Glassdoor
posted_at: 22 days agoschedule_type: Full-time
SUMMARY
Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the CureTM. Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to humankind. We have supported many of the most... impactful new drug approvals in oncology, and we
SUMMARY
Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the CureTM. Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to humankind. We have supported many of the most... impactful new drug approvals in oncology, and we are seeking the most talented individuals globally that are passionate in their desire to assist us in our mission to customize each clinical trial’s imaging to optimize the opportunity to demonstrate efficacy.
Imaging Endpoints is based in Scottsdale, Arizona, with offices in Cambridge, Massachusetts; London, UK; Leiden, Netherlands; Basel, Switzerland; Hyderabad, India and Shanghai, China. We are an affiliate of HonorHealth, one of the largest healthcare systems nationally, and Scottsdale Medical Imaging Limited (SMIL/RadPartners), the largest private radiology group in the United States. We are recognized as the world’s largest and most preeminent iCRO in oncology.
The Imaging Project Manager is responsible for working with sponsors to manage timelines, deliverables and resources, liaise with the appropriate staff to complete work as detailed in the client’s contract and/or work order, and to effectively communicate project status and risks with all internal and external stakeholders.
RESPONSIBILITIES
• Execute project deliverables for imaging studies in clinical trials in accordance with project scope of work and within sponsor specified timelines;
• Manage day-to-day operational aspects of a clinical imaging projects.
• Assist in preparation and adherence to imaging trial documents i.e. Image Review Charter, Imaging Manual, Data Transmittal Forms, etc;
• Ensure project documents are complete, current, and stored appropriately;
• Manage key project documents/processes, i.e. Project Management Plan, Communication Plan, Escalation Plan, Risk Management Plan and appropriate Clinical Trial Management System (CTMS);
• Identify resources needed and assign individual responsibilities;
• Identify out of scope requests and work with appropriate team(s) to revise the work order to meet changing needs and requirements;
• Review and manage all deliverables;
• Prepare metrics reporting for client and senior management;
• Prepare forecasting information for Finance purposes;
• Perform other duties as assigned by the Supervisor
EDUCATION AND EXPERIENCE
• Bachelor’s degree or equivalent certification in a health related field
• Knowledge of Good Clinical Practice (GCP), Quality Assurance/Compliance in a clinical trials setting is required
• Knowledge of key project management documents and tools a must
• Prior experience with different EDC systems required
• Proficiency in MS Office and internet applications required
• Minimum of 3 to 5 years of experience in the clinical trials industry required
• Minimum of 2 years of experience in medical imaging in a clinical trial environment required
• Experience managing global Phase III clinical trials with imaging components strongly preferred
• PMP certification a plus
SKILLS
• Service oriented approach, flexible and proactive towards adapting to sponsors’ needs
• Ability to manage project activities with diverse groups and individuals
• Must have superior attention to detail and excellent oral and written communication skills
• Self-driven, ability to get the job done with little supervision, can-do positive attitude
• Ability to excel in a team environment
• Must have the ability to work under pressure with multiple competing priorities
• Must have strong time management, and organizational skills. Prioritizing workload to the changing needs of the day to day business is also a critical skill.
• Ability to work in strict compliance with all procedures, rules and regulations
• Maintain strict confidentiality of sensitive data, records, files, conversations, etc.
• Must be self-motivated and able to grasp new concepts quickly
• Possess the ability to understand research projects and successfully lead within the clinical trial environment
IMAGING ENDPOINTS’ TEAM CHARACTERISTICS
• Passion to Connect Imaging to the CureTM and pursue a meaningful career by improving the lives of cancer patients through imaging
• Strong desire to be part of a dynamic, global team working closely together and growing year after year in a rewarding environment to help humanity through imaging
• Commitment and caring for our fellow team members, their families, and the communities IE serves – see more information about Caring Endpoints at https://imagingendpoints.com/caring-endpoints/
• Integrity and high ethical standards; we always do the right thing
• High intellect and ingenuity; we enjoy solving problems, finding a better way, and the challenge of making a difference by improving lives
• Structured, organized, detail-oriented, and self-motivated; we approach each day with a detailed plan and excitement to accomplish the day’s objectives while striving to improve ourselves and IE
• Accountable; we do what we say and communicative effectively to meet deadlines; we enjoy advancing clinical trials, helping patients, and celebrating success
• High standard for excellence; we proof our own work, hold high standards for ourselves and our team, and always prioritize quality above all else
PHYSICAL REQUIREMENTS
While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk and hear. The employee is frequently required to sit. Specific vision abilities required by this job include close vision, color vision, ability to adjust focus.
Travel: Travel up to 20% (Domestic and International Show more details...
Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the CureTM. Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to humankind. We have supported many of the most... impactful new drug approvals in oncology, and we are seeking the most talented individuals globally that are passionate in their desire to assist us in our mission to customize each clinical trial’s imaging to optimize the opportunity to demonstrate efficacy.
Imaging Endpoints is based in Scottsdale, Arizona, with offices in Cambridge, Massachusetts; London, UK; Leiden, Netherlands; Basel, Switzerland; Hyderabad, India and Shanghai, China. We are an affiliate of HonorHealth, one of the largest healthcare systems nationally, and Scottsdale Medical Imaging Limited (SMIL/RadPartners), the largest private radiology group in the United States. We are recognized as the world’s largest and most preeminent iCRO in oncology.
The Imaging Project Manager is responsible for working with sponsors to manage timelines, deliverables and resources, liaise with the appropriate staff to complete work as detailed in the client’s contract and/or work order, and to effectively communicate project status and risks with all internal and external stakeholders.
RESPONSIBILITIES
• Execute project deliverables for imaging studies in clinical trials in accordance with project scope of work and within sponsor specified timelines;
• Manage day-to-day operational aspects of a clinical imaging projects.
• Assist in preparation and adherence to imaging trial documents i.e. Image Review Charter, Imaging Manual, Data Transmittal Forms, etc;
• Ensure project documents are complete, current, and stored appropriately;
• Manage key project documents/processes, i.e. Project Management Plan, Communication Plan, Escalation Plan, Risk Management Plan and appropriate Clinical Trial Management System (CTMS);
• Identify resources needed and assign individual responsibilities;
• Identify out of scope requests and work with appropriate team(s) to revise the work order to meet changing needs and requirements;
• Review and manage all deliverables;
• Prepare metrics reporting for client and senior management;
• Prepare forecasting information for Finance purposes;
• Perform other duties as assigned by the Supervisor
EDUCATION AND EXPERIENCE
• Bachelor’s degree or equivalent certification in a health related field
• Knowledge of Good Clinical Practice (GCP), Quality Assurance/Compliance in a clinical trials setting is required
• Knowledge of key project management documents and tools a must
• Prior experience with different EDC systems required
• Proficiency in MS Office and internet applications required
• Minimum of 3 to 5 years of experience in the clinical trials industry required
• Minimum of 2 years of experience in medical imaging in a clinical trial environment required
• Experience managing global Phase III clinical trials with imaging components strongly preferred
• PMP certification a plus
SKILLS
• Service oriented approach, flexible and proactive towards adapting to sponsors’ needs
• Ability to manage project activities with diverse groups and individuals
• Must have superior attention to detail and excellent oral and written communication skills
• Self-driven, ability to get the job done with little supervision, can-do positive attitude
• Ability to excel in a team environment
• Must have the ability to work under pressure with multiple competing priorities
• Must have strong time management, and organizational skills. Prioritizing workload to the changing needs of the day to day business is also a critical skill.
• Ability to work in strict compliance with all procedures, rules and regulations
• Maintain strict confidentiality of sensitive data, records, files, conversations, etc.
• Must be self-motivated and able to grasp new concepts quickly
• Possess the ability to understand research projects and successfully lead within the clinical trial environment
IMAGING ENDPOINTS’ TEAM CHARACTERISTICS
• Passion to Connect Imaging to the CureTM and pursue a meaningful career by improving the lives of cancer patients through imaging
• Strong desire to be part of a dynamic, global team working closely together and growing year after year in a rewarding environment to help humanity through imaging
• Commitment and caring for our fellow team members, their families, and the communities IE serves – see more information about Caring Endpoints at https://imagingendpoints.com/caring-endpoints/
• Integrity and high ethical standards; we always do the right thing
• High intellect and ingenuity; we enjoy solving problems, finding a better way, and the challenge of making a difference by improving lives
• Structured, organized, detail-oriented, and self-motivated; we approach each day with a detailed plan and excitement to accomplish the day’s objectives while striving to improve ourselves and IE
• Accountable; we do what we say and communicative effectively to meet deadlines; we enjoy advancing clinical trials, helping patients, and celebrating success
• High standard for excellence; we proof our own work, hold high standards for ourselves and our team, and always prioritize quality above all else
PHYSICAL REQUIREMENTS
While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk and hear. The employee is frequently required to sit. Specific vision abilities required by this job include close vision, color vision, ability to adjust focus.
Travel: Travel up to 20% (Domestic and International Show more details...
via Salary.com
schedule_type: Full-time
SUMMARY
Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO) that also provides comprehensive Site Management Organization (SMO) services. We are based in Scottsdale, Arizona, with offices in Waltham, Massachusetts; London, UK; Leiden, Netherlands; Basel, Switzerland; Hyderabad, India and Shanghai, China. We are an affiliate of HonorHealth, one of the... largest healthcare systems nationally and Scottsdale
SUMMARY
Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO) that also provides comprehensive Site Management Organization (SMO) services. We are based in Scottsdale, Arizona, with offices in Waltham, Massachusetts; London, UK; Leiden, Netherlands; Basel, Switzerland; Hyderabad, India and Shanghai, China. We are an affiliate of HonorHealth, one of the... largest healthcare systems nationally and Scottsdale Medical Imaging Limited (SMIL/RadPartners), the largest private radiology group in the United States. We operate in over forty countries globally and are recognized as the world’s largest and most preeminent iCRO in oncology.
The Associate Clinical Data Manager’s primary responsibilities are to conduct all clinical data management activities in support of the lead clinical data manager for each assigned clinical study. This includes coordinating with study team members, management and clients to complete work as detailed in the client’s work order; maintaining audit readiness by ensuring study-related documents are in the study eTMF in a timely manner; effectively communicating project status to internal and external stakeholders; and conducting clinical data management activities per relevant standard operating procedures and work instructions as directed by lead clinical data manager. The Associate Clinical Data Manager also performs data processing of project data, such as conducting quality control review and entering data into electronic data capture systems.
RESPONSIBILITIES
• Serve as clinical data management contact in the absence of the lead clinical data manager for assigned clinical studies
• Assist lead clinical data manager in data management aspects of processing radiological images received for client projects in accordance with standard operating procedures
• Support lead clinical data manager in creation and maintenance of data management plans and other related documentation as needed
• Support the design and development of eCRFs to be used in the imaging analysis platform per
• client needs and study criteria as needed by clinical data manager
• Support the design and development of EDC and other databases
• Train IE personnel to use data collection tools, as applicable
• Conduct quality control review of clinical trial data
• Conduct review of eCRFs, reports, or listings, as applicable
• Generate, track, and close queries for images, reports, eCRFs, as applicable
• Support the creation and maintenance of data transfer specifications
• Support delivery of data/image transfers, as applicable
• Monitor radiology readers for applicable on-site reads
• Oversee generation and/or quality control review of Diagnostic and Summary Reports Support applicable data analysis activities
• Support UAT activities for data collection and transfer systems/tools, including creating UAT Plan and Test Cases
• Maintain paper and/or electronic project files in accordance with standard operating procedures Ensure compliance with all standard operating procedures
• Support creation of applicable study specific procedures
• Support creation of applicable study specific reports
• Assist with development and versioning of clinical data management standard operating procedures
• Support lead clinical data manager in the generation and maintenance of study specific data collection tools/databases
• Assist with training and mentoring of other clinical data management staff
• Update appropriate study team members and management with task, deliverable, and project statuses
• Support lead clinical data manager in the creation and maintenance of study timelines to meet data deliverables by planning accordingly
• Contribute to department and company process improvement
• Perform other tasks as needed
EDUCATION AND EXPERIENCE
• Bachelor’s Degree required or equivalent combination of education and relevant work experience
• At least 2 years of prior Clinical Data Coordinator (or equivalent) experience
• Beginning knowledge of analysis software such as SAS
• Beginning knowledge of database development, especially electronic data capture systems used in clinical trials
• Knowledge of Good Clinical Practices
• Working knowledge of medical terminology required
• Knowledge of clinical trials and/or healthcare industries required
• Expertise in using MS Office and internet applications required
SKILLS AND ATTRIBUTES
• Great attention to detail and excellent oral and written communication skills
• Ability to excel in a team environment
• Ability to multitask and work under pressure
• Strong time management and organizational skills. Prioritizing workload to the changing needs of the day-to-day business is a critical skill.
• Ability to assess the importance of a phone call, email, or document and take appropriate action to involve the required parties quickly and accurately
• Ability to work precisely according to all procedures, rules, and regulations
• Must maintain strict confidentiality of sensitive data, records, files, conversations, etc.
• Self-motivated and able to grasp new concepts quickly
PHYSICAL REQUIREMENTS
While performing the duties of this position, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk and hear. The employee is frequently required to sit. Specific vision abilities required by this job include close vision, color vision, ability to adjust focus.
TRAVEL REQUIREMENT
5 – 10% travel (Domestic and International Show more details...
Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO) that also provides comprehensive Site Management Organization (SMO) services. We are based in Scottsdale, Arizona, with offices in Waltham, Massachusetts; London, UK; Leiden, Netherlands; Basel, Switzerland; Hyderabad, India and Shanghai, China. We are an affiliate of HonorHealth, one of the... largest healthcare systems nationally and Scottsdale Medical Imaging Limited (SMIL/RadPartners), the largest private radiology group in the United States. We operate in over forty countries globally and are recognized as the world’s largest and most preeminent iCRO in oncology.
The Associate Clinical Data Manager’s primary responsibilities are to conduct all clinical data management activities in support of the lead clinical data manager for each assigned clinical study. This includes coordinating with study team members, management and clients to complete work as detailed in the client’s work order; maintaining audit readiness by ensuring study-related documents are in the study eTMF in a timely manner; effectively communicating project status to internal and external stakeholders; and conducting clinical data management activities per relevant standard operating procedures and work instructions as directed by lead clinical data manager. The Associate Clinical Data Manager also performs data processing of project data, such as conducting quality control review and entering data into electronic data capture systems.
RESPONSIBILITIES
• Serve as clinical data management contact in the absence of the lead clinical data manager for assigned clinical studies
• Assist lead clinical data manager in data management aspects of processing radiological images received for client projects in accordance with standard operating procedures
• Support lead clinical data manager in creation and maintenance of data management plans and other related documentation as needed
• Support the design and development of eCRFs to be used in the imaging analysis platform per
• client needs and study criteria as needed by clinical data manager
• Support the design and development of EDC and other databases
• Train IE personnel to use data collection tools, as applicable
• Conduct quality control review of clinical trial data
• Conduct review of eCRFs, reports, or listings, as applicable
• Generate, track, and close queries for images, reports, eCRFs, as applicable
• Support the creation and maintenance of data transfer specifications
• Support delivery of data/image transfers, as applicable
• Monitor radiology readers for applicable on-site reads
• Oversee generation and/or quality control review of Diagnostic and Summary Reports Support applicable data analysis activities
• Support UAT activities for data collection and transfer systems/tools, including creating UAT Plan and Test Cases
• Maintain paper and/or electronic project files in accordance with standard operating procedures Ensure compliance with all standard operating procedures
• Support creation of applicable study specific procedures
• Support creation of applicable study specific reports
• Assist with development and versioning of clinical data management standard operating procedures
• Support lead clinical data manager in the generation and maintenance of study specific data collection tools/databases
• Assist with training and mentoring of other clinical data management staff
• Update appropriate study team members and management with task, deliverable, and project statuses
• Support lead clinical data manager in the creation and maintenance of study timelines to meet data deliverables by planning accordingly
• Contribute to department and company process improvement
• Perform other tasks as needed
EDUCATION AND EXPERIENCE
• Bachelor’s Degree required or equivalent combination of education and relevant work experience
• At least 2 years of prior Clinical Data Coordinator (or equivalent) experience
• Beginning knowledge of analysis software such as SAS
• Beginning knowledge of database development, especially electronic data capture systems used in clinical trials
• Knowledge of Good Clinical Practices
• Working knowledge of medical terminology required
• Knowledge of clinical trials and/or healthcare industries required
• Expertise in using MS Office and internet applications required
SKILLS AND ATTRIBUTES
• Great attention to detail and excellent oral and written communication skills
• Ability to excel in a team environment
• Ability to multitask and work under pressure
• Strong time management and organizational skills. Prioritizing workload to the changing needs of the day-to-day business is a critical skill.
• Ability to assess the importance of a phone call, email, or document and take appropriate action to involve the required parties quickly and accurately
• Ability to work precisely according to all procedures, rules, and regulations
• Must maintain strict confidentiality of sensitive data, records, files, conversations, etc.
• Self-motivated and able to grasp new concepts quickly
PHYSICAL REQUIREMENTS
While performing the duties of this position, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk and hear. The employee is frequently required to sit. Specific vision abilities required by this job include close vision, color vision, ability to adjust focus.
TRAVEL REQUIREMENT
5 – 10% travel (Domestic and International Show more details...
via Salary.com
schedule_type: Full-time
SUMMARY
Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO) that also provides comprehensive Site Management Organization (SMO) services. We are based in Scottsdale, Arizona, with an office in Waltham, Massachusetts, and are an affiliate of Southwest Medical Imaging Limited (SMIL/RadPartners), the largest private radiology group in the U.S. We... operate in over thirty countries globally and are recognized
SUMMARY
Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO) that also provides comprehensive Site Management Organization (SMO) services. We are based in Scottsdale, Arizona, with an office in Waltham, Massachusetts, and are an affiliate of Southwest Medical Imaging Limited (SMIL/RadPartners), the largest private radiology group in the U.S. We... operate in over thirty countries globally and are recognized as the preeminent iCRO for complex trials, and one of the world’s largest iCRO’s in Oncology.
Imaging Endpoints (IE) is a rapidly growing Imaging Research and Core Lab in the clinical trials industry that provides centralized evaluation and review of radiology images obtained during a clinical trial. As we grow our team, we are seeking a candidate with the flexibility to adapt to changing business needs, and a diverse set of skills that can be applied to a variety of tasks and goals.
Analysis of user needs and requirements:
• Application installation and testing.
• Application problem resolution.
• Writing user documentation.
• Application and server maintenance.
• Management report creation.
The IT PACS Analyst will be solutions-oriented, facilitate timely deliverables, and meet the needs of the business and all stakeholders with respect to applications and systems support.
RESPONSIBILITIES
• Interface between the departmental users/clients and the various IE Departments.“Connecting Imaging to the Cure”
• Provide day-to-day operational support for imaging applications/solutions provided and or supported by the IT Team.
• Triage network/workstation/hardware related issues.
• Coordinate modifications and updates to the imaging applications and the other applications/systems provided and or supported by the IT Team.
• Provide advanced application troubleshooting support for systems/applications provided and or supported by the IT Team.
• Recommend improvements and increase the efficiency of the imaging applications and other systems/applications provided and or supported by the IT Team.
• Assist with coordination and communication of vendor activities including hardware and software installation.
• Test new systems, version upgrades, interfaces, and other system modifications in accordance with IE QMS processes and procedures.
• Provide pro-active monitoring of the applications/systems provided and or supported by the IT Team.
• Maintaining accurate and current documentation regarding systems/applications provided and or supported by the IT Team.
• Provide on-call coverage for user support.
EDUCATION AND EXPERIENCE
• Bachelor’s degree in Computer Science, Health Informatics, or a related field. Experience will be considered in place of a degree.
• 2years prior PACS Imaging Information Systems experience.
• Strong knowledge of workflow associated with Imaging Core labs and Clinical Trials.
• Strong knowledge of workflow associated with Imaging Core labs and Clinical Trials.
• Understanding of DICOM, HL7, IHE, and other health-related standards.
• Experience working with multiple operating systems, modalities, and clinical systems.
• Experience working with customers, vendors, peers, and management.
• Knowledge of desktop systems support.
• Knowledge and experience working with Citrix virtual desktop highly desirable.
SKILLS
• Strong customer service focus.
• Excellent follow-up skills.
• Work precisely and in compliance with all procedures, rules, and regulations.
• Must maintain strict confidentiality of sensitive data, records, files, conversations, etc.
• Excellent interpersonal, organizational, and communication skills, including oral and written.
• Self-motivated and able to grasp new concepts and learn quickly as well as motivate others.
• Ability to manage projects and deliverables with a high level of accuracy and completeness.
• Excellent hands-on computer skills with thorough knowledge of Microsoft Suite.
• Ability to work independently with minimal supervision.
• Work well in a team environment.
• Ability to analyze data and make recommendations.
• Strong problem solving and analytical skills.
• Must be adaptable in a rapidly changing environment.
• Must be able to multi-task effectively.
• Strong documentation.
PHYSICAL REQUIREMENTS
While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk and hear. The employee is frequently required to sit. Specific vision abilities required by this job include close vision, color vision, ability to adjust focus.
TRAVEL REQUIREMENTS
Estimated 0 — 10 % travel (domestic and international Show more details...
Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO) that also provides comprehensive Site Management Organization (SMO) services. We are based in Scottsdale, Arizona, with an office in Waltham, Massachusetts, and are an affiliate of Southwest Medical Imaging Limited (SMIL/RadPartners), the largest private radiology group in the U.S. We... operate in over thirty countries globally and are recognized as the preeminent iCRO for complex trials, and one of the world’s largest iCRO’s in Oncology.
Imaging Endpoints (IE) is a rapidly growing Imaging Research and Core Lab in the clinical trials industry that provides centralized evaluation and review of radiology images obtained during a clinical trial. As we grow our team, we are seeking a candidate with the flexibility to adapt to changing business needs, and a diverse set of skills that can be applied to a variety of tasks and goals.
Analysis of user needs and requirements:
• Application installation and testing.
• Application problem resolution.
• Writing user documentation.
• Application and server maintenance.
• Management report creation.
The IT PACS Analyst will be solutions-oriented, facilitate timely deliverables, and meet the needs of the business and all stakeholders with respect to applications and systems support.
RESPONSIBILITIES
• Interface between the departmental users/clients and the various IE Departments.“Connecting Imaging to the Cure”
• Provide day-to-day operational support for imaging applications/solutions provided and or supported by the IT Team.
• Triage network/workstation/hardware related issues.
• Coordinate modifications and updates to the imaging applications and the other applications/systems provided and or supported by the IT Team.
• Provide advanced application troubleshooting support for systems/applications provided and or supported by the IT Team.
• Recommend improvements and increase the efficiency of the imaging applications and other systems/applications provided and or supported by the IT Team.
• Assist with coordination and communication of vendor activities including hardware and software installation.
• Test new systems, version upgrades, interfaces, and other system modifications in accordance with IE QMS processes and procedures.
• Provide pro-active monitoring of the applications/systems provided and or supported by the IT Team.
• Maintaining accurate and current documentation regarding systems/applications provided and or supported by the IT Team.
• Provide on-call coverage for user support.
EDUCATION AND EXPERIENCE
• Bachelor’s degree in Computer Science, Health Informatics, or a related field. Experience will be considered in place of a degree.
• 2years prior PACS Imaging Information Systems experience.
• Strong knowledge of workflow associated with Imaging Core labs and Clinical Trials.
• Strong knowledge of workflow associated with Imaging Core labs and Clinical Trials.
• Understanding of DICOM, HL7, IHE, and other health-related standards.
• Experience working with multiple operating systems, modalities, and clinical systems.
• Experience working with customers, vendors, peers, and management.
• Knowledge of desktop systems support.
• Knowledge and experience working with Citrix virtual desktop highly desirable.
SKILLS
• Strong customer service focus.
• Excellent follow-up skills.
• Work precisely and in compliance with all procedures, rules, and regulations.
• Must maintain strict confidentiality of sensitive data, records, files, conversations, etc.
• Excellent interpersonal, organizational, and communication skills, including oral and written.
• Self-motivated and able to grasp new concepts and learn quickly as well as motivate others.
• Ability to manage projects and deliverables with a high level of accuracy and completeness.
• Excellent hands-on computer skills with thorough knowledge of Microsoft Suite.
• Ability to work independently with minimal supervision.
• Work well in a team environment.
• Ability to analyze data and make recommendations.
• Strong problem solving and analytical skills.
• Must be adaptable in a rapidly changing environment.
• Must be able to multi-task effectively.
• Strong documentation.
PHYSICAL REQUIREMENTS
While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk and hear. The employee is frequently required to sit. Specific vision abilities required by this job include close vision, color vision, ability to adjust focus.
TRAVEL REQUIREMENTS
Estimated 0 — 10 % travel (domestic and international Show more details...
Norton safe Web