Senior Oncology Trial Operations Lead

Treeline; Watertown (MA); On-site; USD 125,000 - 180,000; Full time

Job summary

Treeline is seeking a Senior Clinical Trial Manager to join its Clinical Development group. You will oversee trial management for oncology programs, report to the VP of Clinical Operations, and coordinate with CROs and internal teams to ensure compliant execution across studies.

Responsibilities include study material preparation, site/vendor management, risk assessment, and TMF oversight. Strong oncology trial experience and regulatory knowledge are essential.

Qualifications

• Bachelor’s degree, or equivalent, in a biomedical, life science or related field of study.
• 5-8+ years of trial management experience as primary Clinical Trial Manager; Oncology experience required.
• Strong understanding of global regulatory requirements for clinical research.
• Ability to influence and collaborate in a fast-paced environment.

Responsibilities

• Clinical Operations point of contact for execution of clinical studies in compliance with ICH/GCP, Regulatory Authorities' regulations/guidelines, and SOPs/Work Instructions.
• Manage clinical CRO(s) and other study vendors from initial contact through final study deliverables.
• Lead external (CRO) trial management team to ensure conduct in line with regulations and internal SOPs.
• Coordinate CRO activities including monitoring, data management, medical monitoring, medical writing, statistics and safety/pharmacovigilance.
• Provide operational input into study documents including protocol, informed consent, CRFs, and CRO study plans.
• Develop, manage, and maintain study deliverables (timelines, study plans) with stakeholders.
• Identify potential study risks and implement actions to mitigate them.
• Develop/coordinate study training and materials for study team, sites, and vendors.
• Attend site visits (pre-study, site initiation, PI engagement).
• Support TMF management with CRO.

Skills

Trial management

GCP & regulatory knowledge

Vendor management

Cross-functional collaboration

Education

Bachelor’s degree (biomedical/ life sciences)

Job description

Treeline is seeking a Senior Clinical Trial Manager to join its Clinical Development group. You will oversee trial management for oncology programs, report to the VP of Clinical Operations, and coordinate with CROs and internal teams to ensure compliant execution across studies.

Responsibilities include study material preparation, site/vendor management, risk assessment, and TMF oversight. Strong oncology trial experience and regulatory knowledge are essential.