Senior Clinical Project Manager

Department: Regulatory Clinical
Reports to: Clinical Research Manager

The Senior Clinical Project Manager is responsible for the design, execution, and results of clinical studies. This includes building the project plans, developing the protocol, initiating and executing the study, and working with Regulatory to use study results for approvals. The position ensures all studies are conducted in compliance with GCP and all applicable standards and regulations.

Specific Responsibilities

  • Develop clinical protocol
  • Prepare and present study project plan including timelines and budgets for final approval
  • Identify potential CRO vendors; in collaboration with Manager evaluate and select vendors
  • Direct site selection, qualification and enrollment processes
  • Negotiate investigator budgets in collaboration with Finance Department
  • Prepare all documentation associated with clinical studies to include case report forms, informed consent documents, investigator agreements, investigator brochures, case report form completion guidelines, logic checks, data handling guidelines and other required documents
  • Plan, monitor and report patient accrual and implement corrective actions as necessary to meet accrual targets
  • Coordinate the production, labeling and shipment of clinical supplies with Operations groups
  • Provide operational oversight during trial period; complete site visits, report review, report preparation, payments to sites, compilation and completion of TMF
  • Contact for cross-functional study team including sales and marketing personnel; provide accurate and timely study updates for internal Anika stakeholders
  • Monitor CRO activity to ensure study is being conducted according to protocol, timelines and budget
  • Prepare internal files and investigative sites for regulatory inspections; particpate in on-site regulatory audits
  • Complete closeout activities to include final reports
  • Prepare clinical portions of regulatory filings as assigned
  • Maintain internal Quality System documents (SOP, etc.) in compliance with appropriate US and EU regulations
  • Participate in other projects and project teams as required

Required Qualifications:

  • Bachelor’s degree in the life sciences or health care field
  • 6 – 8 years in direct clinical project management experience within the biopharmaceutical or medical device industry
  • Demonstrated experience as a Project Manager on multi-center, FDA regulated IDE and/or IND studies

 Desired Experience, Knowledge, and Skills:

  • Master’s degree in the life sciences or related health care field preferred
  • Knowledge of medical terminology, physiology and pathophysiology is required. Experience in Orthobiologics indications preferred.
  • Experience working with CROs and outside vendors in monitoring trials
  • Prior experience with EDC systems
  • Excellent computer skills, specifically with Microsoft Office Suite is required
  • Professional presentation, verbal and written communication skills are required
  • Demonstrated ability to collaborate, multi-task and work effectively in a fast-paced matrixed environment


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