Associate Clinical Project Manager
About The Position
Reporting to the VP of Clinical Operations or delegate, the Associate Clinical Project Manager (ACPM) will support the planning, execution and delivery of clinical trials in accordance with ICH/GCP and applicable regulatory requirements, timelines, budget, and quality standards. This role will partner closely with Clinical Operations, CROs, vendors, and cross functional stakeholders to ensure efficient trial conduct and issue resolution. The Associate CPM role may be responsible for global or regional study management tasks as assigned by the clinical operations study management team. This role is based in our Lexington, MA office.
Requirements
- Requires a Bachelor’s Degree in health or biologic science (BS/BA/ BScN or higher) with a minimum of 3 years clinical operations experience in biopharmaceutical industry; global clinical trial experience and rare disease experience is highly preferred
- Experience in study project management and prior management of contracted resources, including CROs, is required
- Strong knowledge of Good Clinical Practices; international clinical trial experience and knowledge of other country regulatory requirements is preferred
- Proficient in use of electronic clinical database software and other programs such as Microsoft Office
Nice To Haves
- Site monitoring and clinical quality compliance experience are strongly preferred
- global clinical trial experience and rare disease experience is highly preferred
- international clinical trial experience and knowledge of other country regulatory requirements is preferred
Responsibilities
- Trial planning and execution: Support development and maintenance of clinical trial plans, timelines, and milestones
- Assist with study start-up, including site activation tracking and vendor onboarding
- Monitor study progress against timelines, identifying risks and escalating issues appropriately
- Support trial close-out activities and documentation
- Contribute to site monitoring oversight by tracking and reviewing monitoring visit reports as agreed with the clinical operations study management team
- Vendor and CRO oversight: Coordinate day-to-day interactions with CROs and vendors
- Track deliverables and ensure adherence to scope of work
- Review vendor metrics and support issue resolution
- Participate in vendor meetings
- Cross-functional coordination Support with internal study team meeting minuting, tracking and follow up of decisions and actions, and other cross-functional coordination tasks as agreed with the clinical operations study management team
- Collaborate with the cross-functional team as agreed with the clinical operations study management team
- Support communication between internal team and external partners
- Documentation and compliance Assist in development and review of study plans and manuals
- Support inspection readiness activities and TMF completeness
- Ensure trial conduct aligns with ICH-GCP, SOPs, applicable regulations, and study plans / manuals
- Reporting and tracking Maintain study trackers, dashboards, and logs for decision, action and risks
- Track budgets, invoices, and forecast updates under supervision
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
251-500 employees
