Senior Clinical Trial Manager

BioTalent; Watertown (MA); Hybrid; USD 153,000 - 198,000; Full time

Job summary

BioTalent is hiring a Senior Clinical Trial Manager – Oncology in Watertown, MA. The role is hybrid and full-time, reporting to the VP of Clinical Operations. Base salary ranges from $153,000 to $197,600, depending on experience.

You will oversee oncology trials, manage CROs, coordinate cross-functional teams, and ensure regulatory compliance while maintaining study timelines and budgets.

Qualifications

• Bachelor’s degree in biomedical, life sciences, or related discipline.
• 5–8+ years of clinical trial management experience in biotechnology/pharma/CRO.
• Oncology clinical trial experience required.
• Strong knowledge of ICH/GCP and global regulatory requirements.
• Experience overseeing CROs and external study vendors.
• Understanding of study timelines, budgets, and deliverables.

Responsibilities

• Serve as Clinical Operations lead for execution of oncology studies in accordance with ICH/GCP and SOPs.
• Manage CROs and external vendors from engagement to final study deliverables.
• Lead external trial management teams ensuring studies meet regulatory standards and study requirements.
• Coordinate CRO activities across clinical monitoring, data management, medical monitoring, and statistics.
• Contribute to study documents including protocols, informed consent forms, CRFs, and study plans.
• Develop and maintain study timelines, milestones, and risk mitigation plans.
• Monitor enrollment and provide progress reporting; support TMF maintenance.
• Engage sites and vendors through pre-study visits, initiation visits, and ongoing PI interactions.

Skills

Organizational skills

Problem-solving

Interpersonal skills

Teamwork

Written communication

Verbal communication

Education

Bachelor’s degree in biomedical or life sciences

Job description

Senior Clinical Trial Manager – Oncology

Watertown, MA | Full-Time | Hybrid

Base Salary: $153,000–$197,600, based on experience

The Opportunity

A growing biotechnology company is seeking an experienced Senior Clinical Trial Manager to join its Clinical Development organization and support the execution of its oncology clinical programs.

Reporting to the VP of Clinical Operations, this individual will play a key role in the operational management and execution of clinical trials, working closely with internal cross-functional teams, investigational sites, CROs, and other external vendors.

The position will have responsibility across study planning and execution, CRO and vendor oversight, enrollment tracking, study documentation, timelines and deliverables, risk management, and site engagement.

Key Responsibilities

• Serve as a key Clinical Operations point of contact for the execution of clinical studies in accordance with ICH/GCP requirements, applicable regulatory guidelines, and internal SOPs/work instructions.
• Manage and oversee CROs and other clinical study vendors from initial engagement through final study deliverables.
• Lead external CRO trial management teams and ensure studies are conducted in accordance with applicable regulations, GCP, ICH guidelines, and study requirements.
• Coordinate CRO activities across functions including clinical monitoring, data management, medical monitoring, medical writing, biostatistics, and safety/pharmacovigilance.
• Provide operational input into key study documents, including clinical protocols, informed consent forms, CRFs, study plans, and CRO-generated documentation.
• Develop, manage, and maintain study timelines, operational plans, milestones, and deliverables in collaboration with internal and external stakeholders.
• Track study enrollment and provide appropriate study progress reporting.
• Proactively identify operational risks and develop appropriate mitigation and contingency plans.
• Develop and coordinate study training and supporting materials for internal study teams, investigational sites, and vendors in partnership with medical and scientific colleagues.
• Participate in both in-person and virtual site activities, including pre-study/selection visits, site initiation visits, and PI engagement meetings.
• Support the oversight, quality, and ongoing maintenance of the Trial Master File (TMF) maintained by the CRO.
• Build and maintain strong working relationships with investigational sites, CRO partners, vendors, and internal cross-functional stakeholders.

Qualifications

• Bachelor’s degree, or equivalent, in a biomedical, life sciences, or related discipline.
• 5–8+ years of clinical trial management experience serving as the primary Clinical Trial Manager or equivalent within a biotechnology, pharmaceutical, or CRO environment.
• Oncology clinical trial experience is required.
• Strong knowledge of ICH/GCP and global clinical research regulatory and compliance requirements.
• Demonstrated experience managing and overseeing CROs and external study vendors.
• Strong understanding of how operational decisions can impact study timelines, budgets, deliverables, and overall trial outcomes.
• Excellent organizational, problem-solving, interpersonal, and teamwork skills.
• Strong written and verbal communication skills.
• Ability to effectively collaborate with and influence internal and external stakeholders within a fast-paced, growing clinical development environment.

Location

This is a hybrid position based in Watertown, Massachusetts and is not a remote opportunity. Candidates must be able to work from the Watertown office and attend in-person study-related meetings or site visits as required.

Compensation

The anticipated base salary range for this position is $153,000–$197,600 annually. Final compensation will be determined based on relevant experience, education, qualifications, and other job-related factors.