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Project Manager

Job Summary:

Evaluates and manages all aspects of assigned clinical research programs and provides line management to assigned project managers and/or project coordinators.

 

Essential Job Functions:

  1. Provide daily management and oversight of assigned clinical research programs, promoting teamwork, and resolving conflicts as needed.
  2. Ensure proper conduct of ongoing clinical research trials in compliance with applicable protocols, FDA regulations, ICH/GCP guidelines, appropriate company and /or client SOP’s, and professional standards.
  3. Manage study budget and scope of work for assigned projects/programs according to contracted scope of work; identify and communicate potential out of scope activities to client and relevant departments.
  4. Continuously evaluate assigned projects for areas where improvements can be made and implement efficiencies to improve the quality of work delivered to the client.
  5. Establish good working relationships with client project teams to ensure client satisfaction.
  6. Ensure efficient identification and successful selection of investigational research sites for participation in clinical research trials (if applicable).
  7. Prepare/review investigator clinical trial agreements and negotiate study budgets as required.
  8. Develop, implement, and revise project-specific operational plans (e.g., project plan, project specific QC plan, monitoring plan, communication plan, and data management plan) and other guidance documents to ensure efficient workflow.
  9. Assist with the development of case report forms, monitoring tools, and necessary study guides for project teams and investigational research sites (as applicable).
  10. Develop and implement study/program timelines in conjunction with internal team and client.
  11. Develop and maintain project tracking spreadsheets to ensure current monitoring of study/program progress.
  12. Define project/program resource needs and manage resources effectively.
  13. Communicate with clients regarding project status and study-related issues. Act as primary client liaison.
  14. Coordinate and manage all contracted tasks (e.g. clinical monitoring, data management, regulatory affairs, serious adverse event reporting, final study reports, etc.) associated with assigned clinical studies.
  15. Coordinate activities of vendors as required.
  16. Participate in required project-specific teleconferences or face-to-face meetings.
  17. Participate in client audits or regulatory authority inspections (if applicable) and oversee follow-up to audits.
  18. Prepare proposal materials and participate in presentations to clients; assist with other business development activities.
  19. Evaluate staff training needs and assist in training and development of staff; mentor staff as needed.

Education:

  • Bachelor’s degree required (preferably in health science).

Experience/Training:

Must have Clinical Research Project Management experience, ideally at a CRO.

Candidate should have experience managing multicenter trials across multiple Therapeutic Areas including but not limited to: GI, Respiratory, Dermatology or Oncology.  

  • 5+ years of relevant experience in clinical research and operations at a CRO, Biotechnology/Pharmaceutical company
  • Thorough knowledge of drug development, the project management process, FDA regulations, and ICH/GCP guidelines. Global project management experience recommended.
  • Strong knowledge of relevant US and EU regulations
  • Excellent computer skills with various software programs including Microsoft Word, Excel, MS Project and Outlook.
  • Skilled in financial control procedures for assigned studies.
  • Excellent organizational and planning skills.
  • Fluent in English with excellent oral and written communication skills used in educating, guiding, training, and negotiating.
  • Demonstrated problem solving, interpersonal and leadership skills
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