Senior Clinical Trial Manager

Clinical Trial Manager

Location: Waltham, MA (Greater Boston Area) | Hybrid (2 days on-site per week)

Reports to: Chief Medical Officer

Employment Type: Full-time

Experience Level: 5+ years (Senior Manager to Associate Director level)

[Position Overview]

• Lead and provide hands-on operational support for clinical operations, collaborating closely with other Senior Clinical Operations Managers.
• Oversee and manage the day-to-day execution, tracking, and monitoring of clinical studies, ensuring all essential trial documentation (TMF) is accurately collected, maintained, and filed.
• Ensure all clinical trials are conducted in strict compliance with study protocols, SOPs, ICH/GCP guidelines, and all applicable regulatory requirements.

[Key Responsibilities]

Trial Oversight & Execution

• Drive study start-up, site activation, patient recruitment, and study conduct across global clinical sites.
• Oversee and coordinate the development, review, and tracking of essential regulatory documentation (e.g., financial disclosures, FDA 1572, GCPs, protocol amendments, and IRB/IEC submissions).
• Review Site Visit Reports (SQVs, SIVs, IMVs, COVs) for protocol adherence, quality, and resolution of site issues.
• Partner with internal and external supply teams to oversee Investigational Product (IP) accountability and logistics from release through final disposition.

Vendor & CRO Management

• Manage external study partners, including CROs, central laboratories, imaging vendors, and other specialized trial suppliers to ensure deliverables meet timeline, budget, and quality standards.
• Monitor study budgets, track clinical milestones, and review vendor invoices for accuracy and timely payment processing.

Quality, Compliance & TMF Management

• Maintain the Trial Master File (TMF/eTMF) in full adherence to applicable SOPs, WIs, policies, and regulatory guidelines, supporting regular quality control (QC) and reconciliation.
• Maintain continuous audit and inspection readiness; support preparations, conduct, and responses for internal reviews and regulatory inspections.
• Ensure trial, country, and site-level information is accurately maintained within Clinical Trial Management Systems (CTMS) and study repositories.

Protocol & Systems Collaboration

• Contribute to the development and user acceptance testing (UAT) of eTMF, EDC, and study-specific databases.
• Support the development and review of Case Report Forms (CRFs) and CRF Completion Guidelines (CCGs).
• Lead or participate in cross-functional study team meetings, investigator meetings, and Study Initiation Visits (SIVs), driving action items to timely resolution.
• Identify operational risks and proactively propose process improvements to optimize trial delivery.

[Qualifications]

Education

• BA/BS degree in Life Sciences, Nursing, or a related scientific discipline (Advanced degree preferred)

Required Experience

• 5+ years of direct clinical trial management experience within the biopharmaceutical industry or CRO setting.
• Demonstrated experience managing oncology clinical trials, preferably in early-phase (Phase 1/2) global or U.S. studies under an IND.
• Proven track record of managing CROs, vendors, and study budgets with a hands-on execution mindset.

Knowledge, Skills and Abilities

• In-depth knowledge of ICH/GCP guidelines, FDA regulations, and applicable global clinical trial standards.
• Proficiency in Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), and electronic TMF platforms (e.g., Veeva Vault).
• Excellent cross-functional collaboration, project management, and problem-solving skills.
• Strong attention to detail with the ability to prioritize and multitask effectively in a fast-paced, evolving biotech environment.
• Excellent written and spoken English communication skills.
• Flexibility to collaborate across international time zones (US and Asia/Korea).

[Working Arrangements & Location]

• Office Location: Waltham, MA (Applicants eligible to work in the Greater Boston Area).
• Work Model: Hybrid (2 days on-site in the Waltham office per week, with 3 days remote flexibility).

[Why Voronoi]

Join a dynamic oncology biotech where your scientific expertise directly contributes to advancing first-in-class therapies for patients with oncologic diseases worldwide.

At Voronoi, we value collaboration, integrity, and curiosity — and we empower every team

member to make a meaningful impact.

Voronoi is proud to be an equal opportunity employer. We are committed to fostering a diverse and inclusive workplace where every individual is valued, respected, and empowered to contribute to our

shared mission of advancing transformative oncology therapies. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or any other characteristic protected by applicable law.