Clinical Research

Clinical Project Manager Direct Hire MA

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Job ID: 14893 Direct Hire MA

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Hot, new start-up backed by well-known Venture Firm here in the Greater Boston Area is growing!  They are looking to bring on board a Clinical Project Manager who will be responsible for the planning and management of the operational aspects of clinical trials, including CRO and vendor selection and management/oversight and ensure project milestones and objectives are met.  This CPM will join a dynamic, rapidly growing, and highly collaborative team!  Responsibilities include but not limited to:

  • Collaborate with internal and external team members for the planning and execution of clinical trials.
  • Lead/oversee all operational activities to ensure deliverables are prioritized and goals and objectives are met and/or changed accordingly.
  • Develop and manage project timelines and budgets; help ensure project deliverables are on time and within agreed upon budget and amended accordingly
  • Accountable for coordination of planning, initiation, completion, and reporting of clinical protocols within or across programs from team endorsement to reporting.
  • Ensure clinical trials meet time, quality and cost targets consistent with the overall Clinical Development Plan.
  • Lead the development of and provide input into study-related documents, including clinical protocols, ICFs, CRFs, monitoring plans, study, lab and pharmacy manuals, data management plans, etc.
  • Contribute to department process development, such as the development and writing of Standard Operating Procedures (SOPs) and Work Practices (WPs).
  • Collaborate with legal and finance (and others, as needed) on the development and management of study specific agreements (i.e. non-disclosure agreements, clinical trial agreements, clinical research organization agreements, payment terms, etc.)
  • Oversee the conduct of studies and ensure studies are implemented according to the study protocols and in compliance with local, ICH, GCP and company policies and procedures.
  • Monitor clinical study site activities and visit sites as needed
  • Track, collect, and review clinical documentation for clinical trials or ensure this is being done by CRO

Requirements:

  • B.A./B.S. degree in the science/healthcare field, a nursing degree, or equivalent combined education.
  • At least 7 years of Clinical Trial Management/Clinical Operations experience required. Experience in oncology preferred.
  • Must have experience in CRO oversight.
  • Excellent Leadership skills; ability to collaborate across disciplines.
  • Detailed knowledge of GCP, ICH Guidelines and current US FDA regulations.
  • Ability to travel up to approximately 25% of time.