Clinical Study Lead (CTM II)
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What you'll do
- Vendor (e.g., CRO, Biometrics, IXRS, PK/Central Lab, eTMF, Safety) oversight for adherence to budget, timelines and organizational objectives of individual protocols/programs.
- Develops strong vendor and site relationships and ensures continuity of relationships through all phases of the trial.
- Obtains and maintains in-depth understanding of the study protocol and related procedures in order to contribute strongly to study team knowledge by sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
- Coordinates & manages various tasks in collaboration with other sponsor roles to achieve site readiness, such as study materials and approval for drug shipping/receipt according to procedure.
- Performs timely review of monitoring reports from CRO and associated deliverables demonstrating sponsor oversight.
- Perform periodic reviews of the CRO eTMF/TMF to ensure adherence with standards and compliance with the relevant regulations and guidelines.
- Works with vendors to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met.
- Supports financial management of the study which includes review and approval of site and vendor invoices.
- Supports risk Management initiatives
- Supports audit/inspection activities as needed.
- Maintain clinical trial registry entry/updates, as required.
- Provides mentorship/guidance to junior team members or cross-functional colleagues on study processes/study requirements.
What they're looking for
- Undergraduate degree or its international equivalent preferably in clinical, science, or health related field from an accredited institution; a licensed health-care professional, i.e., registered nurse
- 5 years of relevant experience including 3 years of experience in clinical trial management
- Reads, writes and speaks fluent English; fluent in language of host country.
- This is a hybrid role - office based three days per week in Warren, NJ, Armonk, NY or Cambridge, MA
- Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.
As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.
What you will be doing
Vendor (e.g., CRO, Biometrics, IXRS, PK/Central Lab, eTMF, Safety) oversight for adherence to budget, timelines and organizational objectives of individual protocols/programs.
Develops strong vendor and site relationships and ensures continuity of relationships through all phases of the trial.
Obtains and maintains in-depth understanding of the study protocol and related procedures in order to contribute strongly to study team knowledge by sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
Coordinates & manages various tasks in collaboration with other sponsor roles to achieve site readiness, such as study materials and approval for drug shipping/receipt according to procedure.
Performs timely review of monitoring reports from CRO and associated deliverables demonstrating sponsor oversight.
Perform periodic reviews of the CRO eTMF/TMF to ensure adherence with standards and compliance with the relevant regulations and guidelines.
Works with vendors to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met.
Supports financial management of the study which includes review and approval of site and vendor invoices.
Supports risk Management initiatives
Supports audit/inspection activities as needed.
Maintain clinical trial registry entry/updates, as required.
Provides mentorship/guidance to junior team members or cross-functional colleagues on study processes/study requirements.
Your profile
Undergraduate degree or its international equivalent preferably in clinical, science, or health related field from an accredited institution; a licensed health-care professional, i.e., registered nurse
5 years of relevant experience including 3 years of experience in clinical trial management
Reads, writes and speaks fluent English; fluent in language of host country.
This is a hybrid role - office based three days per week in Warren, NJ, Armonk, NY or Cambridge, MA
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Salary Range
$121,576.00-$151,970.00Are you a current ICON Employee? Please click here to apply
Company
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