Senior Clinical Trial Manager

Treeline Biosciences • Watertown, MA

123d

About The Position

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.

Requirements

• 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

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 101-250 employees