Clinical Trial ManagerLocation: Hybrid | Boston, MA
Employment Type: Full-time
About the RoleThe
Clinical Trial Manager (CTM) is responsible for supporting the day-to-day management of clinical studies from startup through closeout. This role is ideal for someone who is energized by cross-functional collaboration, proactive problem-solving, and the pace of an emerging biotech. The CTM will oversee CROs, vendors, timelines, budgets, and ensure inspection-ready execution across all phases of the trial.
Key ResponsibilitiesStudy Planning & Execution
- Support the overall operational planning, study startup, site selection, and activation activities under the direction of senior Clinical Operations leadership.
- Assist in the development and review of core study documents (protocols, ICFs, etc.) and drive the development of study plans, manuals, and training materials.
- Ensure studies are conducted in accordance with ICH-GCP, regulatory requirements, and internal SOPs.
CRO & Vendor Oversight
- Serve as the day-to-day operational contact for CROs and external vendors, supporting escalations to senior Clinical Operations leadership as appropriate.
- Oversee monitoring activities, enrollment performance, site engagement, and risk mitigation.
- Review vendor deliverables, KPIs, and quality metrics; escalate issues proactively.
Clinical Operations Leadership
- Assists with the overall management of study timelines, budgets, and forecasting; support contract and SOW development.
- Lead cross-functional study team meetings and ensure alignment across Clinical Development, Biometrics, Safety, and Regulatory.
- Support inspection readiness and contribute to audit responses and CAPAs.
Data & Quality Oversight
- Partner with Data Management on database build, data cleaning, and query resolution.
- Review clinical data listings, safety narratives, and protocol deviations.
- Ensure high-quality documentation and TMF completeness.
Study Closeout
- Oversee site closeout, reconciliation activities, and final study reporting.
- Contribute to CSR development and lessons-learned processes.
Qualifications- Bachelor's degree in life sciences or related field; advanced degree preferred.
- 5+ years of clinical operations experience in biotech/pharma, with direct CTM-level ownership of clinical studies.
- Strong understanding of ICH-GCP, clinical trial processes, and vendor oversight.
- Experience working in small or emerging biotech environments strongly preferred.
- Ability to manage multiple priorities, anticipate issues, and comfortable operating with a high degree of autonomy as well as under the guidance of senior team members.
- Excellent communication, organization, and cross-functional leadership skills.
What We Offer- The opportunity to play a foundational role in a mission-driven biotech start-up.
- A collaborative, science-driven culture where operational excellence is valued.
- The ability to shape the office environment and operational backbone of a growing company.
- Competitive compensation and benefits.
