Clinical Project Manager

Canton, MA

Job ID: 613

Job Req code: 613

Category: Clinical Affairs

Job Type: OI Surgical and Sports Medicine

The Clinical Project Manager will be responsible for the daily management of clinical trials for the Surgical & Sports Medicine (SSM) product portfolio from completion of study start-up activities through close out. This individual will be responsible for leading all operational aspects of Organogenesis’s SSM clinical trial programs including study initiation, site monitoring, data management/analysis, study reports and clinical quality assurance. Finally, the person in this position is accountable for adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.


  • Serve as the main contact for CROs.
  • Interact with internal cross-functional teams to develop trial database(s), procedures, and training programs to support assigned clinical trials.
  • Manage efforts to ensure timely completion of contracted deliverables.
  • Proactively anticipate issues and prepare contingency plans with oversight.
  • Ensure all procedures conform to regulatory standards.
  • Establish and maintain required study documentation.
  • Train and manage Clinical Research Associate(s) and independent contractors;
  • Monitor trial progress and budget.
  • Manage escalation of issues and communicate as appropriate.
  • Produce reports and presentations as required.
  • Assist with monthly project invoices and financials
  • Provide status updates to appropriate parties.
  • Routinely review key performance indicators and timelines with Head/Director of Clinical Operations to address risks and/or issues to ensure deliverables are met.


  • M.S. /B.S. in life sciences, scientific or other relevant discipline.

  • 5+ years of strong hands-on experience leading multi-center clinical trials in specifically Knee osteoarthritis and spine studies

  • Experience with Phase 3 and post-marketing trials

  • Proven ability to build strong relationships with external partners, CROs, and vendors including extensive experience managing contracts and clinical finance activities.

  • In-depth, working knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and regulatory guidelines for clinical trial management

  • Ability to work independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members

  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.

  • Must have strong time management, organizational, communication (oral and written), and analytical skills
  • Familiarity with MS Office applications (Word, Excel, PowerPoint, Visio, and Project)