Senior Clinical Trial Manager

Treeline; Watertown (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

Treeline is seeking a Senior Clinical Trial Manager with oncology-focused Clinical Operations experience to join our growing Clinical Development group. This role reports to the VP of Clinical Operations and will be responsible for providing trial management support for oncology programs, including study materials, enrollment tracking, and site and CRO/vendor relationship management.

Key duties include overseeing CRO activities to ensure compliance with ICH/GCP, regulatory rules, and SOPs;

Qualifications

• Bachelor’s degree or equivalent in biomedical or life science field.
• 5–8+ years of trial management experience as primary Clinical Trial Manager (or equivalent).
• Oncology experience required.
• Strong understanding of global regulatory and compliance requirements for clinical research.

Responsibilities

• Clinical Operations point of contact for execution of clinical studies in compliance with ICH/GCP and SOPs.
• Manage clinical CROs and study vendors from initial contact to final study deliverables.
• Lead external CRO trial management team to ensure conduct per regulations and SOPs.
• Coordinate CRO activities including monitoring, data management, medical monitoring, and safety.
• Provide operational input into study documents (protocols, informed consent, CRFs).
• Develop and maintain study deliverables (timelines, plans) with stakeholders.
• Identify and mitigate potential study risks.
• Develop training/materials for study team, sites, and vendors.
• Attend site visits and support TMF management.

Education

Bachelor’s degree, or equivalent, in a biomedical, life science or related field

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