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Location:Boston, Massachusetts (Hybrid – 2–3 days/week in-office)
A growing, innovative biotech company is seeking aClinical Trial Managerto lead the planning, execution, and oversight of a First-in-Human (FIH) clinical trial for a novel therapeutic candidate. This role provides the opportunity to work at the forefront of clinical research, managing global end-to-end trial activities and ensuring alignment with clinical and regulatory milestones.
The successful candidate will bring a strategic mindset, operational excellence, and strong leadership skills to help advance the company’s clinical development goals in a dynamic and collaborative environment.
Key Responsibilities
- Lead day-to-day operations for global clinical trials across major functional areas, with an initial emphasis on start-up activities.
- Manage site feasibility, site selection, site initiation, and ongoing monitoring processes.
- Serve as the primary point of contact for all clinical trial stakeholders including internal teams, CROs, and other external vendors.
- Oversee financial aspects of the trial including vendor budgets, investigator grants, invoice reviews, and forecasting.
- Organize and lead clinical trial trainings such as investigator meetings and site initiation visits.
- Contribute to the development and finalization of key trial documents including study protocols and clinical study reports.
- Coordinate IRB/IEC and regulatory submissions to support global trial compliance and timelines.
- Champion proactive communication, accountability, and problem-solving across cross-functional teams.
- Conduct risk assessments and mitigation planning throughout trial execution.
- Support regulatory inspections and quality audits as a Subject Matter Expert (SME).
- Provide mentorship and leadership to junior Clinical Operations staff as needed.
Qualifications
- Bachelor’s degree (or equivalent experience), preferably in a life science or health-related discipline.
- Minimum of 8 years of experience in clinical trial management within pharmaceutical, biotech, or CRO settings.
- Proven expertise in global trial conduct, vendor oversight, and stakeholder management.
- Strong knowledge of clinical research methodologies, Good Clinical Practice (GCP), ICH guidelines, and global regulatory requirements.
- Effective at managing timelines, budgets, and collaborative vendor relationships.
- Demonstrated leadership in fostering cross-functional collaboration and delivering operational results.
- Willingness to travel up to 20% as needed.
Seniority level
- Seniority levelMid-Senior level
Employment type
Job function
- Job functionResearch and Management
- IndustriesBiotechnology Research, Pharmaceutical Manufacturing, and Hospitals and Health Care
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