The Senior Clinical Trial Manager must fully understand and lead the cross-functional team through all day-to-day activities within the clinical trial life cycle. These day to day activities include managing all trial start-up, conduct and close-out activities to both industry and corporate standards within ICH/GCP Guidelines. Though this is a hybrid role, candidates must live local and be able to visit our Cambridge location 1-3 days per week as needed.
- Have the skillset and experience to manage all project team activities related study start up, conduct and close out activities.
- Work with Outsourcing and Contracts Management to ensure Site Contracts reflect trial activities and related budget. Manage Change Orders with Sites (and Vendors when necessary), including checking for accuracy of invoices and cost of services versus accruals.
- Contribute to development of Informed Consent Form and provide oversight and approval for all country and site level ICF in collaboration with the CRO to manage the daily operational management activities of CROs and study vendors.
- Contribute to (or oversee the management of) the creation of the trial plans and site facing documents.
- Develop (or overseeing the development of) all training/day to day materials, including SIV materials, Investigator Meeting materials, Amendment Training Materials, Lab Manuals, Pharmacy Manuals, and any other trial-specific trainings for sites and internal team members.
- Support data management activities such as reviewing study-related support materials created by Data Management, including the study manual, edit check manual, clean patient data tracker, listing review process and the Statistical Analysis Plan; participate in all the related activities and data cleaning activities throughout the life of the trial; organize/plan data snapshots as necessary for internal and external reviews and data deliveries.
- Monitor (and escalate appropriately) vendor metrics and vendor performance, including KPIs, review of Monitoring Reports for content and compliance, deviation reporting, data cleaning activities, enrollment activities, etc.
- Organize, oversee and/or participate in all study related meetings, including Investigator teleconferences, Clinical Study Team meetings, Vendor update calls, Safety Review Committee meetings, Data Safety Monitoring Board, etc. as appropriate.
- Develop and maintain (or oversee) the development of the Trial Master File, ensuring the final TMF is final and audit ready at the close of the study.
- Participate and support all audit, SOP and quality activities for CROs, the vendors, the sites, etc. to ensure alignment and consistent quality exist across the trial.
- (CTM) Bachelor's Degree in a related field with 8+ years' experience managing clinical trials, 5+ in the biotech and/or pharmaceutical industry.
- Phase I experience is preferred, particularly in Oncology or Rare Disease development.
- Experience with GCP/ICH Guidelines, and a strong understanding of cross-functional clinical processes.
- Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem solving ability.
- Ability and willingness to travel up to 20% (domestic and international).
- Candidates must live local and be able to visit our Cambridge location 1-3 days per week as needed.