Sr. Clinical Trial Manager

Senior Clinical Trial Manager

Location:

Boston, MA
Therapeutic Area:
Oncology (heme-onc)
Salary Range: $151,000–$175,000

An innovative, rapidly growing biotechnology company is seeking an experienced Senior Clinical Trial Manager to join its Clinical Operations team and lead the start-up and execution of large, global clinical trials.

The ideal candidate will thrive in a fast-paced, small-company environment where priorities can shift quickly, and success requires flexibility, strong judgment, and the ability to navigate uncertainty. This individual will be responsible for the management and oversight of CROs and external vendors while managing study timelines, budgets, and operational plans within a fully outsourced clinical trial model.

This position requires excellent global study management and communication skills, along with the ability to collaborate effectively across Clinical Development and other cross-functional teams.

Responsibilities Support the overall management of one or more global clinical trials, including study planning, start-up, execution, and closeout

Lead operational activities in alignment with clinical development plans, study objectives, timelines, and budgets.

Assist with the evaluation, selection, management, and oversight of CROs, vendors, and external consultants

Manage outsourced clinical activities and ensure CRO and vendor deliverables meet quality, timeline, and regulatory expectations

Contribute to the development and review of clinical documents, including protocols, informed consent forms, Investigator Brochures, trial reports, ASRs/DSURs, and study status updates.

Review and approve study-related operational plans generated by CROs and vendors.

Ensure clinical trial documentation is maintained in an audit-ready state, including the Trial Master File.

Review clinical monitoring visit reports and ensure outstanding follow-up items are addressed appropriately and on time.

Proactively identify study risks and develop and implement appropriate mitigation strategies.

Develop productive relationships with clinical sites and investigators to support effective Sponsor-site collaboration.

Assist with the planning and execution of investigator meetings.

Monitor clinical study progress and provide regular reporting on study activities, budgets, timelines, risks, and milestones.

Conduct periodic visits to clinical sites and/or CROs as necessary to evaluate study progress and protocol compliance.

Participate in the preparation and review of SOPs.Collaborate cross-functionally with Clinical Development, Data Management, Biostatistics, Regulatory, Pharmacovigilance, and other drug-development functions.

Requirements BA/BS degree required7+ years of applicable clinical trial experience

At least 5 years of CRO and vendor management experience

Experience managing Phase III oncology clinical trials required.

Strong experience managing global clinical studies

Experience operating within a fully outsourced clinical trial model.

Thorough knowledge of FDA, EMA, ICH and GCP requirements governing global clinical trials.

Demonstrated ability to manage complex study timelines, budgets, vendors, and competing priorities.

Strong understanding of the multidisciplinary functions involved in drug development, including Data Management, Biostatistics, Regulatory Affairs, and Pharmacovigilance.

Strong interpersonal and communication skills with the ability to effectively interact with investigators, vendors, and colleagues across all levels of an organization.

Self-motivated and proactive, with excellent organizational and relationship-building skills.

Ability to work effectively in a fast-paced, entrepreneurial biotechnology environment.

Strong working knowledge of Microsoft Office and electronic clinical…