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.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • 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.

Requirements

  • 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)