Clinical Trial Manager

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Boston, Massachusetts (Hybrid – 2–3 days/week in-office)A growing, innovative biotech company is seeking a

Clinical Trial Manager

to 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 ResponsibilitiesLead 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.QualificationsBachelor’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 level Mid-Senior levelEmployment type

Employment type Full-timeJob function

Job function Research and ManagementIndustries Biotechnology Research, Pharmaceutical Manufacturing, and Hospitals and Health CareReferrals increase your chances of interviewing at Biotech Partners by 2xGet notified about new Clinical Trial Manager jobs in

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