Associate Clinical Project Manager

Role Summary

The Associate Clinical Project Manager (ACPM) supports the planning, execution, and delivery of clinical trials in accordance with ICH/GCP and regulatory requirements, timelines, budget, and quality standards. The role partners with Clinical Operations, CROs, vendors, and cross-functional stakeholders to ensure efficient trial conduct and issue resolution. The ACPM may be responsible for global or regional study management tasks as assigned. This role is based in Lexington, MA.

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, identify risks and escalate issues; 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 internal study team meeting minuting, tracking and follow-up of decisions and actions; 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 decisions, actions, and risks; track budgets, invoices, and forecast updates under supervision.

Qualifications

• Required: Bachelor’s Degree in health or biologic science (BS/BA/BScN or higher) with a minimum of 3 years clinical operations experience in the biopharmaceutical industry.
• Required: Experience in study project management and prior management of contracted resources, including CROs.
• Preferred: Global clinical trial experience and rare disease experience.
• Preferred: Site monitoring and clinical quality compliance experience.
• Preferred: Strong knowledge of Good Clinical Practices; international clinical trial experience and knowledge of other country regulatory requirements.
• Required: Proficient in use of electronic clinical database software and Microsoft Office.

Skills

• Strong project management and organizational skills
• Excellent cross-functional collaboration and communication abilities
• Analytical mindset with attention to detail
• Ability to identify risks and escalate issues appropriately

Education

• Bachelor’s Degree in health or biologic science (BS/BA/ BScN or higher)