Clinical Study Lead (CTM II)

• 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

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.