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Clinical Project Manager

Clinical Project Manager

Job description

We are looking for several passionate and collaborative individuals who 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 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.
  • 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.

Requirements:

  • BSN or Bachelor's Degree in scientific discipline or health-related field
  • Minimum 5 years clinical development experience in industry with at least 4 years as trial manager
  • 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
  • Experience in Rare Disease, Pediatric, and/or complex clinical trials preferred

If you or a Clinical Project Manager you know feel this could be an opportunity you would like to explore please send your most up to date resume to myself at Sara.Shields (at sign) Realstaffing.com to discuss this role.

Thank you!

Sthree US is acting as an Employment Agency in relation to this vacancy.