Most recent job postings at iconplc
via ICON Careers - ICON Plc posted_at: 1 day agoschedule_type: Full-time
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. Position Overview... • Project support: Responsible for coordination, tracking and management of logistics in support of clinical trials. Operational support: Responsible for special projects ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

Position Overview...
• Project support: Responsible for coordination, tracking and management of logistics in support of clinical trials. Operational support: Responsible for special projects supporting departmental operations.
• Clinical study team member: works closely with the Clinical Trial Manager (CTM) and is responsible for coordination, tracking, and management of logistics in support of clinical trials.
• Responsible for tracking study budgets, including invoice and PO management/reconciliation, month end actuals and accruals in support of the CTM and Finance. Also responsible for investigator and vendor payments for in-house studies.
• Works closely with CTM and legal to review and approve clinical trial agreements and site specific study budgets.
• Tracks study status, enrollment, regulatory documentation, and site start-up status for assigned clinical projects including review and approval of regulatory package for release of clinical supply.
• Reviews clinical trial documentation including monitoring visit reports, monitoring plans, communication plans, timelines, etc.
• Responsible for set-up, maintenance, reconciliation, and archiving of electronic and paper Trial Master Files. Coordinates TMF transfer with CROs.
• Responsible for data entry, database maintenance, and reporting in Clinical Trial Management Systems.
• Maintains access rights to Clinical Trial Management Systems.
• Interacts with CROs, vendors, investigators, monitors and other external partners to provide information and resolution for specific study requests and issues.
• Works with CRO and Study Start-Up (SSU) to collect and review essential regulatory documents prior to site initiation/study drug release.
• Assists CTM in review of study plans.
• Assists CTM in review and approval of informed consent templates.
• Participates in user acceptance testing (UAT) for EDC/IWRS.
• Manages and coordinates logistics for clinical and non-clinical supplies.
• Responsible for agendas and meeting minutes for clinical study team meetings.
• Manages logistics and coordinates investigator meetings, CRO kick-off meetings, and vendor meetings along with CTM and external meeting planners.
• Responsible for routing, tracking, and coordinating site and CRO/vendor Confidential Disclosure Agreements (CDAs), contracts and change orders with Associate Director Clinical Operations, legal, and finance departments.
• Responsible for facilitating site advertisement review and approval with CCC Committee.
• Mentors and trains CTAs and new hires on departmental procedures and systems.
• Responsible for special projects supporting operations/departmental initiatives such as ClinicalTrials.gov, SOPs, GCP, process enhancements, outsourcing, Sunshine Act, systems implementation, training, etc.

Education/Skills and Experience Requirements:
• Bachelor’s degree or equivalent undergraduate degree with science or healthcare experience
• Experience: minimum 3-5 years clinical research experience in a pharmaceutical/biotech, CRO setting
• Solid knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials
• Strong interpersonal, organizational, and multi-tasking skills
• Excellent attention to detail and problem solving skills
• Self-motivated and displays initiative
• Perform job duties with minimal supervision and guidance
• Ability to work effectively work in a team setting

Physical Demands and Work Environment:
• Travel domestic and international – up to 10%

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:
• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
• *Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level
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via ICON Careers - ICON Plc posted_at: 21 hours agoschedule_type: Full-time
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. The Director Clinical Research Scientist is responsible for working with the physicians within Clinical Development to provide clinical... research support for the assigned studies. What ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

The Director Clinical Research Scientist is responsible for working with the physicians within Clinical Development to provide clinical... research support for the assigned studies.

What you will be doing:
• Development of protocols for clinical studies.
• Contribute to the development of program strategy for Oncology compounds/programs including participation in the preparation of clinical development plans.
• Drafting of clinical scientific documents such as IND, IND amendments, Clinical Study Reports, Investigator Brochures, Annual Reports, and other health authorities submissions.
• Monitor, review, and summarize clinical safety and efficacy data in ongoing studies.
• Collaborate with study team members to conduct timely and thorough review of study data using best practices and available tools to identify and evaluate data trends.
• Will lead the clinical matrix teams for assigned studies, represent clinical development on project teams and serve as liaison to project teams, CRO's and others.
• Develop relationships with appropriate consultants and external experts and utilize these relationships to obtain feedback on protocol design.
• Contribute to writing and review of study abstracts, posters, oral presentations, and manuscripts for assigned studies.

You are:
• Degree in scientific/life-sciences field. Pharm.D. or Ph.D. preferred.
• Minimum of 4 - 6 years of experience in research with at least 3 or more years of clinical research/drug development experience are required for Director level.
• Experience in Oncology Drug Development required.
• Ability to multi-task and work in a fast-paced environment.
• Excellent written and oral communication skills.
• Strong Analytical ability.
• Ability to accommodate up to 20% domestic and international travel or as business dictates.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:
• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles
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via ICON Careers - ICON Plc posted_at: 23 hours agoschedule_type: Full-time
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. What you will be doing... The Sr. Clinical Supply Operations Specialist provides support to the Clinical Drug Supply & Logistics group in the Investigational Product (IP) distribution process, ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

What you will be doing...

The Sr. Clinical Supply Operations Specialist provides support to the Clinical Drug Supply & Logistics group in the Investigational Product (IP) distribution process, ancillary supplies process and comparator procurement process, for one or more molecules across multiple Therapeutic areas; supporting highly complex studies as well as long-term departmental and cross-functional projects and on-going continuous improvement initiatives. This may include leading short-term projects. Activities are performed on time, within budget and with good quality, in compliance with Regulatory Authorities’ regulations / guidelines and Regeneron Standard Operating Procedures (SOPs) / Work Practice Documents (WPDs). This role applies to internally sourced studies and/or CRO/Partnered studies.

What you will be doing:
• IP Supply & Inventory Planning:
• Accountability, Reconciliation, Returns & Destruction (ARRD)
• Internal System Management including lot creation, batch status, and inventory maintenance
• Assessment and Oversight activities (risks, stocking levels, trends)
• IP Shipments
• System and Non-system generated Shipments
• Depot transfers o Temperature Excursion Management
• IP Supply Monitoring & Activity Documentation (Electronic Trial Master File - eTMF)
• Expected Document List (EDL) creation
• eTMF Document Management per regulatory requirements
• QA/QP Release Management
• Pack-and-label kit and sequence reconciliation
• Inspection Readiness activities
• IRT management activities including IRT Alert management and UAT activities
• Suspected Serious Non-Compliance support
• Ancillary Supply & Inventory Planning/Management
• Procurement support (Includes Work Order Management)
• Vendor RFI support o Supply Planning & Inventory Management
• Ancillary Supply Plan creation
• Shipping & Logistics (Includes International Logistics requirements for Ancillaries)
• Shipping & logistics activities
• Temperature Excursions
• Lot management
• eTMF activities
• ARRD activities
• Comparator Planning & Management
• Market Intelligence Reports
• Quote/PO/Requisition Process Support
• IMN Creation
• Document Storage
• Temperature Excursions
• Financial Forecasting, Budgeting & Planning
• Forecast Submissions
• Order Ticket Entry
• Demand Updates

You are:
• BS/BA degree in a related field. Minimum of 3+ years of experience in the following fields:
• Clinical Supplies
• QA/Regulatory
• Precision Medicine
• Supply Chain
• Manufacturing
• Or equivalent research/commercial biopharma experience
• Hybrid Role: The person in this role would need to be onsite 3 days a week in Basking Ridge, NJ to start for training for 2-3 months. Once fully trained will reduce to 2 days required weekly onsite---Local candidates to the NJ location only will be considered.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:
• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles
Show more details...
via ICON Careers - ICON Plc posted_at: 24 hours agoschedule_type: Full-time
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. What you will be doing... • Lead the development of Digital Health Operations (DHO) deliverables to meet the needs of the study/program and internal stakeholders. • Provide technical expertise ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

What you will be doing...
• Lead the development of Digital Health Operations (DHO) deliverables to meet the needs of the study/program and internal stakeholders.
• Provide technical expertise in Digital Health and specification development, and provide subject matter expertise to cross-functional study teams.
• Lead all DHO-related activities and serve as the main point of contact for the cross-functional study team.
• Maintain an awareness of industry benchmarks and evaluate innovative new technologies to ensure the Digital Health Center of Excellence (CoE) processes are at the "best practice" level of performance.
• Support various Digital Health technologies, as needed: eCOA/COA, Imaging, ECG, eConsent, Direct to Patient, Telemedicine, Actigraphy, etc.

Specific Duties:
• Provide advice/recommendation to study teams regarding supplier(s) and technology alternatives.
• Complete Requests for Proposal documentation and recommend appropriate suppliers to support study needs.
• Provide leadership and expertise for the completion of supplier specification development and set-up activities through the lifecycle of a trial.
• Lead the cross functional study team through changes of scope, providing technical expertise on the change of scope, assessment of risk, and oversight of system requirements updates.
• Lead the resolution of issues escalated by study teams under the supervision of Digital Health line management.
• Serve as the point of contact specific to inspection readiness activities between the study team and the Digital Health technology suppliers.
• Effectively manage internal and external business partner relationships in support of R&D Operations’ deliverables.
• Monitor key performance indicators (KPIs) and metrics for services provided by suppliers.
• Conduct Lessons Learned sessions following the completion of study start-up activities and throughout other phases of the clinical development process, as necessary.
• Effectively support the study team in close-out/deactivation of the technology system.

You are:
• Bachelor’s degree or equivalent education / relevant experience
• 3+ years of operational experience in clinical trials within a pharmaceutical company and/or a CRO
• Expertise working with clinical technologies (eCOA exp. is a must)
• Demonstrated knowledge of clinical development processes, global clinical operations, and strategic planning
• Familiarity with industry best practices for vendor management
• Strong project management and presentation skills
• Good understanding of various therapeutic areas (Oncology, Metabolism, Immunology, Infectious Disease & Vaccines, Neuroscience, and/or Pulmonary Hypertension preferred)
• Experience with Digital Health technology suppliers (preferred)

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:
• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles
Show more details...
via ICON Careers - ICON Plc posted_at: 4 days agoschedule_type: Full-time
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. What you will be doing... • Manages all aspects of the medical writing function. • Writes and reviews clinical study reports, protocols, and other clinical/regulatory documents. • Contributes ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

What you will be doing...
• Manages all aspects of the medical writing function.
• Writes and reviews clinical study reports, protocols, and other clinical/regulatory documents.
• Contributes to clinical protocol development for first-in-human oncology studies.
• Demonstrates technical expertise and background in the use of medical writing templates and software (eg, PleaseReview, Documentum-based platforms, etc.).
• Writes clear and concise documents, including study reports, protocols, investigator brochures, summary documents, and other scientific documents
• Drive the document preparation process, receive and review primary statistical output, draft and distribute documents for review, and incorporate/resolve comments with all reviewers.
• Acts as a lead medical writer on complex programs and numerous individual studies.
• Provides

You are:
• Advanced degree in a relevant scientific/clinical/regulatory field preferred
• At least 5 years of experience in a lead medical writing role in the pharmaceutical/CRO industry. *Note: Immunology experience is preferred but not required.
• Excellent writing skills.
• Ability to understand and interpret clinical and scientific data; ability to present results in an understandable manner to a variety of audiences.
• Knowledge of current requirements and guidelines applicable to submission documents
• Excellent interpersonal and oral communication skills.
• Strong knowledge of MS Word, Excel, PowerPoint, and Outlook
• Ability to prioritize multiple projects
• To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:
• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles
Show more details...
via ICON Careers - ICON Plc posted_at: 6 days agoschedule_type: Full-time
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. What you will be doing... • Perform complaint and deviation investigations, creation of appropriate CAPA's and drive CAPA's to closure. • Ensure clinical supplies are processed according ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

What you will be doing...
• Perform complaint and deviation investigations, creation of appropriate CAPA's and drive CAPA's to closure.
• Ensure clinical supplies are processed according to GMPs.
• Participate as subject matter expert during internal or external audits.
• Manage change control for existing packaging equipment.
• Coordinate re-evaluation (RED) dating extension request packaging campaigns.
• Perform several aspects of SOP Administration, including authoring SOP's and coordinating training activities.
• Manage the ordering and inventory levels for non-GMP packaging components (trays, etc.).
• Manage projects for new technologies.
• Participate, facilitate and lead risk assessments.

Educational Requirements:
• Bachelor’s degree preferred

Required Experience/Skills:
• 0-3+ years (with degree)
• 3+ years (without degree)
• Organization, detail oriented, equipment operation skills, equipment repair, problem solving, troubleshooting, interpersonal skills including verbal and written, multitasking, collaboration
• Ability to execute on a task and follow up on its completion

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:
• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles
Show more details...
via ICON Careers - ICON Plc posted_at: 14 days agoschedule_type: Full-time
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. The Clinical Research Associate (CRA) monitors the progress of clinical studies at investigative sites or remotely, ensuring clinical... trials are conducted, recorded, and reported in accordance ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

The Clinical Research Associate (CRA) monitors the progress of clinical studies at investigative sites or remotely, ensuring clinical... trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), International Conference on Harmonization Good Clinical Practices (ICH-GCP) and all applicable regulatory requirements.

What you will be doing:
• Completes onsite and remote monitoring activities in accordance with all ICH-GCP guidelines, applicable regulations, SOPs, and study processes. Activities include qualifying potential investigative sites, initiating clinical trials, maintaining study files, and providing instructions to site personnel and study close out.
• Verifies the protection of study participants by confirming informed consent procedures and protocol have been performed in accordance to applicable regulations.
• Ensures the integrity of clinical data and that the study is conducted in compliance with the approved protocol, GCP, applicable regulations, and SOPs.
• Manages the investigative site staff to facilitate trial deliverables, e.g., subject enrollment, data deliverables.
• Verifies proper management and accountability of Investigational Product (IP).
• Writes and submits reports of investigational site findings and updates applicable tracking systems. Escalates observed deficiencies, issues, and corrective and preventative action plans as appropriate.
• Manages essential documents as required by local regulations and ICH-GCP guidelines before, during, and after a clinical study; assists with resolution of investigational site/data queries.
• Performs key risk assessment and management responsibilities throughout the project, including key risk indicator and site health analysis, site process evaluation, and project escalation.
• Participates in audit preparation and follow-up activities as needed.
• Independently performs a variety of onsite and offsite monitoring visit types.
• Gathers and reviews information for assigned sites and identifies inconsistencies. With limited guidance from project and functional management, assesses risk and escalates as appropriate.
• Assists with non-complex ad hoc, short-term assignments in support of additional studies or departmental initiatives.
• May serve as preceptor, providing training to less experienced clinical team members

You are:
• 2 years of experience supporting clinical trials including 1 year of on-site monitoring experience
• In-depth knowledge of the drug development process
• In-depth knowledge and practical utilization of ICH- GCP and applicable regulatory requirements
• Sound knowledge of applicable policies and procedures, SOPs, work instructions and other guidance documents
• Good spoken and written communication skills; good presentation skills
• Strong interpersonal, collaboration and time management skills
• High proficiency with Microsoft Office and company collaboration applications
• Excellent skill in the utilization of applicable clinical systems
• Excellent critical thinking skills
• Excellent organizational skills
• Ability to focus on detail for extended periods of time; high attention to accuracy
• Ability to travel extensively
• Ability to establish and maintain effective working relationships with investigative site staff
• Undergraduate degree or international equivalent in clinical, science, or health-related field from an accredited institution; health care professional licensure, i.e., registered nurse
• Equivalent combination of education, training and relevant experience may be considered in place of the education and experience stated above. All employees must read, write and speak fluent English and host country language.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:
• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles
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via ICON Careers - ICON Plc posted_at: 25 days agoschedule_type: Full-time
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. The Clinical Research Associate may be regionally based and is responsible for the monitoring of clinical trial activities in compliance... with FDA regulations, ICH/GCP guidelines and company ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

The Clinical Research Associate may be regionally based and is responsible for the monitoring of clinical trial activities in compliance... with FDA regulations, ICH/GCP guidelines and company SOPs, to support New Drug Applications. The CRA will support project teams in the placement, implementation, communication, site management, recruitment and retention (R&R) issue identification and resolution, and activities required at the conclusion of clinical studies, as stipulated in the monitoring plans for assigned projects.

What you will be doing:

Study Planning
• Contribute to the identification of new sites for clinical trials; analyse capability and support CRMA and CSM in making recommendation for trial inclusion.
• Assume ambassadorial role to facilitate communication between sites and Novartis CPO to increase value proposition to investigators.
• Facilitate the preparation and collection of site and country level documents during all phases of the trial. Supports the CSM in the oversight of Country and Site Trial Master Files (TMF). During all phases of the trial ensure archiving per relevant SOP.
• Negotiate investigator remuneration; prepare financial contracts between investigational sites and investigators. Ensure adherence to payment schedule.

Study Execution
• Implement complete site management including monitoring visits, regulatory assessment, drug supply management, etc. to ensure compliance with protocol, GCP, global and local regulations, global and local processes.
• Identify problems at sites; resolve issues and escalate as appropriate.
• Collaborate with the CSM to ensure recruitment and execute contingency plans, as needed.
• Complete preparation and generation of visit monitoring reports as per relevant SOP
• Review and manage data at site; resolve technical and content issues on a continuous basis in order to achieve timely database lock targets.
• If working with central CRAs (blinded and un-blinded), respond to alerts and follow-up to ensure resolution of issues

Study Close-out
• Implement site close-out activities and generate site close-out report.
• Provide feedback on site performance for future trial site feasibility/selection

General
• Improve skills by timely completion performance of assigned global and local training.

You are:
• Minimum 1 year prior monitoring experience with global trials.In-depth knowledge of FDA regulations and ICH/GCP guidelines
• Bachelors of Science
• Excellent interpersonal and communication skills (verbal & written), including proficiency in medical terminology and computer systems
• Ability to work effectively with investigators and other research personnel, maintaining a professional demeanor
• Ability to independently resolve site or study related issues
• Self motivated; detail oriented; team player; flexible
• Ability to prioritize workload to meet project timelines, while managing multiple protocols across therapeutic areas
• Excellent organizational and time management skills
• Function effectively with high degree of personal accountability
• CCRA or SoCRA certified

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:
• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles
Show more details...
via ICON Careers - ICON Plc posted_at: 4 days agoschedule_type: Full-time
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. What you will be doing... • Planning, management, and oversight of clinical study execution in accordance with the global program strategy, through leadership of the cross-functional Local ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

What you will be doing...
• Planning, management, and oversight of clinical study execution in accordance with the global program strategy, through leadership of the cross-functional Local Study Team (LST).
• Supports country-level operational planning and accountable for site selection within assigned country/-ies.
• Contributes and develops to program/study-specific materials – e.g., monitoring plan, study specific training documents.
• Supports and contributes to Clinical Study Teams (CSTs) / Trial Management Teams (TMTs) as applicable, agenda driven, present at meetings.
• Communicates country status (including timelines and deliverables) to key stakeholders (e.g., Global Clinical Managers [GCM], Program Managers, CST or TMT, Development Operations Manager [DOM] etc) with oversight as required and ensures updates to relevant systems.
• Accountable for site-level goal setting and study-specific deliverables for clinical sites within their country/-ies.
• Contributes to, deliver and/or lead CRA, Investigator and Study Coordinator training.
• Provides oversight and monitoring of applicable vendor activities e.g., laboratories and equipment provisioning.
• Engages with local cluster team and local functions from a study perspective (e.g., Local Medical Affairs team, DOM)
• Provides country level input
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