Senior Clinical Trial Manager, Cambridge, MA

About the role

The Senior Clinical Trial Manager will fully understand and independently lead the cross-functional team through all activities within the clinical trial life cycle. These will include daily activities managing all trial start-up, conduct and close out activities to both industry and corporate standards within ICH/GCP Guidelines.

Responsibilities

• Execute/ manage execution of all related study start-up, maintenance and close out activities.
• Demonstrates an AI-curious mindset, with an interest in exploring and leveraging emerging AI technologies to streamline contract lifecycle management and enhance operational efficiency.
• Strategic and analytical thinker with excellent problem-solving capabilities and adaptability in fast-paced, matrixed environments.
• Build strong cross-functional relationships, mentor team members, and drive efficient business solutions across functional and regional boundaries.
• Manage Change Orders and re-scoping with vendors and sites when necessary, including checking for accuracy of invoices and cost of services versus accruals.
• Drive, contribute to and support the writing of all related clinical documents (such as the Protocol, ICF, DSUR, IB, CSR) for timely and accurate submission readiness.
• Manage creation of the trial plans and their update when necessary, to ensure they remain current.
• Develop (or oversee the development of) all training/ day to day materials, including SIV materials, amendment training materials, lab manuals, pharmacy manuals, and any other trial-specific training.
• Support data management activities such as reviewing study-related 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 data cleaning activities throughout the life of the trial; organize/ plan data snapshots as necessary for internal and external reviews and data deliveries.
• Maintain vendor metrics and vendor performance, including KPIs, review of monitoring reports for content and compliance, deviation reporting, data cleaning activities, enrollment activities, etc.
• Seek out, assess and potentially assist in onboarding potential AI solutions within this space that would prove helpful to the organization.
• Carefully coordinate and 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.
• Assist the CRO in eTMF development and maintenance to ensure the final TMF is complete and audit ready at the close of the study.
• Participate and support all audit, SOP and quality activities to ensure alignment and consistent operational excellence exist across the trial.

Qualifications

• A Bachelor's Degree in a related field with a minimum of 6 years experience in the biotech and/or pharmaceutical industries.
• At least 3+ years managing oncology or rare disease trials.
• A thorough understanding of GCP/ICH Guidelines, as well as strong understanding of cross-functional clinical processes.
• Excellent interpersonal and communication skills for relationship building, verbal and written.
• Proactive problem solving, planning and project management skills are necessary.
• Strong outsourced model experience, with budget management of vendors, is essential.
• Ability and willingness to travel up to 30%.

Skills

• Prior CRA experience and/or willingness to co-monitor if needed.
• Prior site experience, coordinator or other is a plus.