1 week ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. Location: 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 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 level Mid-Senior level Employment type Employment type Full-time Job function Job function Research and Management Industries Biotechnology Research, Pharmaceutical Manufacturing, and Hospitals and Health Care Referrals increase your chances of interviewing at Biotech Partners by 2x Get notified about new Clinical Trial Manager jobs in Greater Boston . Senior Clinical Project Manager/Clinical Project Manager (Remote) Boston, MA $140,000.00-$160,000.00 6 days ago Waltham, MA $139,000.00-$191,000.00 5 days ago Boston, MA $65,000.00-$75,000.00 20 hours ago Sr. Clinical Trial Manager (Early Phase) Associate Director, Clinical Operations (Trial Master File) Clinical Research Manager – Cutaneous Oncology Senior Director, Global Clinical Development Woburn, MA $253,000.00-$299,000.00 1 week ago Sr. Clinical Trial Manager- Ophthalmology Associate Director, Clinical Outsourcing Waltham, MA $175,000.00-$200,000.00 1 week ago Clinical Research Manager – Genitourinary Oncology Senior Director, Clinical Operations/Development We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
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