Clinical Trial Manager

Biotech Partners

Boston

Hybrid

GBP 89,372 - 119,163

Full time

14 days+

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Job summary

A growing biotech company seeks a Clinical Trial Manager to drive the planning and execution of a First-in-Human clinical trial for a novel therapeutic. This role combines strategic oversight with operational execution while ensuring compliance with regulatory requirements and fostering collaboration across teams.

Qualifications

Bachelor’s degree or equivalent experience in life sciences.
8+ years of experience in clinical trial management.
Strong knowledge of GCP and ICH guidelines.

Responsibilities

Lead day-to-day operations for global clinical trials.
Manage site feasibility, selection, and initiation.
Oversee financial aspects including vendor budgets.

Skills

Leadership

Project Management

Operational Excellence

Clinical Research Knowledge

Education

Bachelor’s degree in Life Science or Health-related discipline

Job description

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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