Clinical Project Manager

Dicerna – Cambridge, MA

We are looking to hire a Clinical Project Manager. This individual 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.

Responsibilities
  • 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 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
  • Train study team members, external monitors, and site staff as needed
  • Requirements
  • Bachelors degree in a scientific discipline or another relevant field. Master s degree preferred.
  • Minimum of 5 years of clinical development experience in the pharmaceutical/biotechnology industry
  • At least 2 years of experience as a clinical trial manager
  • Experience in rare disease, pediatric, and/or complex clinical trials preferred
  • Experience with global clinical trial operations in multiple phases of research
  • Strong knowledge of GCP, ICH and FDA regulations
  • Experience with all aspects of trial and site startup and vendor management
  • Ability to deal with multiple priorities having aggressive timelines with attention to detail
  • Ability to find creative solutions to issues impacting timelines and budgets
  • Proficient in MS Office
  • Willingness to travel up to 20% of the time, domestically and internationally
  • This job posting is no longer available on OPTnation.
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