iconplc

  • Encrypted
    Site is Encrypted

  • Country
    Hosted in Ireland

  • Latitude\Longitude
    37.751 / -97.822    Google Map

  • Traffic rank
    #125,503 Site Rank

  • Site age
    17 yrs old

  • Site Owner information
    Whois info

Traffic rank
#125,503
Site age
17 yrs
Location
Ireland
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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
Show more details...
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
Show more details...
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...
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