Clinical Project Manager
JOB TITLE: Clinical Project Manager
REPORTING RELATIONSHIP: Associate Director, Clinical Operations
DATE AVAILABLE: Immediately
LOCATION: Lexington, MA
JOB DESCRIPTION AND RESPONSIBILITIES:
The Clinical Project Manager (CPM) will be responsible for the hands-on management of early and late-stage clinical studies:
- Drive activities internally and externally to ensure timely and successful execution for clinical trial activities.
- Manage all logistical and operational activities for the clinical trial(s) including internal and external project team oversight.
- In conjunction with Clinical Project Associate(s), oversee:
- Trail Master File (TMF) maintenance
- Essential document collection for IRB/EC and country submissions, and investigational medicinal product (IMP) release to study sites
- Study progress and issues (site qualification through close-out)
- Monitoring visit and report status
- Safety Report preparation and dissemination
- Clinical data activities
- Oversee the tracking and communication of overall study status – including maintenance of current, complete and accurate status reports.
- Development and review of key study documents including: study manuals, training materials, tools, and templates.
- Maintain current, complete and accurate budgets, IMP and study supply forecasts.
- Ensure inspection readiness in compliance with company processes and regulatory requirements.
- Prepare and manage detailed project plan in MS Project.
- Assist with the preparation and presentation at investigator meetings as required to ensure that the clinical and investigational site staff team is well informed about the study and related procedures.
JOB QUALIFICATIONS AND REQUIREMENTS:
- Educated to degree level (biological science, pharmacy, or other health related discipline preferred) or equivalent nursing qualification/experience.
- Minimum 3-5 years of industry experience within clinical research/operations.
- Experience managing global clinical trials in rare diseases with orphan drug designation is a plus.
- Excellent interpersonal, verbal and written communication skills (including presentation skills).
- Ability to manage multiple and varied tasks and prioritize workload with attention to detail.
- Able to take initiative and work independently with sense of urgency in completing assigned tasks.
- Flexibility towards work assignments, new learning and travel (overnight, weekend and international travel may be required). Flexibility to accommodate travel up to 30%.
- Team player with outstanding negotiation skills and organizational skills.
- Computer Proficiency: MS Office suite and working knowledge of MS Project required.