Clinical Project Manager

About the Department

Our East Coast Global Development Hub brings together the best minds in life science innovation with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple innovative modalities and therapeutic areas. Our East Coast Global Development Hub merges biotech speed and agility with large pharmaceutical company quality, resources, and stability, uniting the best of both worlds to develop new medicines for patients. We recognize that improving human health starts here and that patients rely on us. We’re changing lives for a living. Are you ready to make a difference?

 

The Position

We are looking to hire a Clinical Project Manager (CPM). This is a unique opportunity to work in a growing Clinical Operations Department that manages multiple early-stage clinical programs based on an innovative RNAi technology platform. The CPM will be responsible for all aspects of clinical trial management aimed at treating a rare or infectious liver-targeted disease. You will be responsible for the successful execution of clinical trials from protocol finalization through closeout.

 

Relationships

Reports to: Director, Clinical Operations.

 

Essential Functions

• Oversee performance of CROs, third party vendors, and contractors, including co-monitoring, to ensure compliance with study protocol, and identifying areas of concern and escalating to Clinical Program Lead when appropriate
• Collaborate with the Clinical Program Lead and study team to develop patient recruitment strategies, operational feasibility and implementation of study objectives
• Develop study plan(s) including key milestones and timelines
• Ensure country and site selection meet study requirements
• Participate in the development and testing of clinical systems (e.g., data capture, IxRS)
• Ensure internal and external systems are updated in a timely manner (e.g., trackers, clinicaltrials.gov)
• Manage critical study documents, such as consent forms, study manuals, subject recruitment materials
• Oversee the Trial Master File (TMF) and assist with periodic audit of the TMF
• Drive critical clinical trial activities including trial site activations, recruitment, and database lock
• Assist in contract and budget negotiations with clinical sites and vendors as well as budget review and forecasting
• Independently manage interactions with clinical monitors, data management, safety, regulatory, pharmaceutical science and QA team members, both internally and externally
• Participate in the development of tools and metrics for monitoring clinical study progress and surveillance of key efficacy and safety data points
• Collaborate with other functions (at CRO or internally) to ensure robust plans for study level data review, including trend evaluation
• Provide input in internal/external study related audits, review resulting reports
• Review monitoring reports and, if applicable, corrective action plans at individual sites and provide oversight to ensure safety concerns are identified and responses developed
• Communicate trial status, issues, and mitigations to relevant cross-functional stakeholders
• Represent Dicerna during site initiation visits, trainings, close out visits, and conduct co-monitoring visits as needed
• Train study team members, external monitors, and site staff as needed

 

Physical Requirements

10-20% overnight travel required.

 

Qualifications