Senior Clinical Trial Manager

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

We are seeking a Senior Clinical Trial Manager with relevant Clinical Operations experience to join our growing Clinical Development group who will be responsible for providing trial management support for our oncology programs. This role will report to the VP, Clinical Operations. Job responsibilities include, but are not limited to, preparation of study related materials, enrollment tracking and reporting, relationship management with study sites and vendors (in particular CROs), supervision of study-related activities, identification of project risks and contingency planning.

Responsibilities:

• Clinical Operations point of contact for execution of clinical studies in compliance with ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/Work Instructions
• Manage clinical CRO(s) and other study vendors from initial contact through to final study deliverables.
• Lead external (CRO) trial management team, to ensure conduct in accordance with State and Federal regulations, GCP regulations, ICH guidelines, and internal SOPs
• Ensure coordination of the CRO activities are timely, coordinated and complete, including but not limited to clinical monitoring, data management, medical monitoring, medical writing, statistics and safety/pharmacovigilance.
• Provide operational input into study documents including clinical protocol, informed consent, CRFs, any and all CRO study documents/study plans.
• Develop, manage, and maintain study deliverables [i.e. timelines, study plans, etc.] through collaboration with internal and external stakeholders
• Proactively identify potential study risks and develop/implement actions to avoid or mitigate potential risks
• Develop/coordinate study training and associated materials for study team, investigational sites, and vendors in collaboration with medical and scientific colleagues both internally and externally
• Attend (in person and virtual) study site visits, such as pre-study selection visits, site initiation visits, and PI engagement meetings
• Responsible for supporting the management, oversight and maintenance of the Trial Master File (TMF) held by the CRO

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 (or equivalent) within Pharma, Biotech or CRO; Oncology experience required.
• Strong understanding of global regulatory and compliance requirements for clinical research
• Strategic understanding of how outcomes, budgets, and timelines are impacted by decisions.
• Outstanding teamwork, organizational, interpersonal, and problem-solving skills
• Effective communicator both verbally and in written form
• Ability to influence and collaborate well with colleagues and partners in a fast-paced growing development company