Senior Clinical Trial Manager, Cambridge, MA

Your impact 

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. The Senior Clinical Trial Manager may also have program responsibilities and managerial responsibilities, working in tandem with the Head of Clinical Operations as the department grows.

What you will do 

• Have the skillset and experience to 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.
• Proven ability to 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.
• Monitor 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. 
• 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.

Skills and qualifications 

Essential:

• The successful candidate will have 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 
• 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%  

Nice to have:

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