Senior Clinical Trial Manager

Treeline Biosciences; Watertown (MA); On-site; USD 90,000 - 150,000; Full time

Job summary

An established industry player is looking for a Senior Clinical Trial Manager to enhance their Clinical Development group. This pivotal role involves managing clinical trials for oncology programs, ensuring compliance with regulatory standards, and leading a team of external partners. The ideal candidate will possess extensive experience in trial management, particularly within Pharma or Biotech, and will be adept at navigating the complexities of clinical operations. Join a dynamic team where your expertise will directly contribute to advancing innovative treatments and improving patient outcomes. If you thrive in a collaborative environment and are passionate about clinical research, this opportunity is perfect for you.

Qualifications

• 5-8+ years of trial management experience in Pharma, Biotech or CRO.
• Strong understanding of global regulatory and compliance requirements.

Responsibilities

• Manage clinical CRO(s) and study vendors for trial execution.
• Develop and maintain study deliverables in collaboration with stakeholders.
• Identify project risks and implement mitigation strategies.

Skills

Clinical Operations Management

Regulatory Compliance

Risk Management

Team Collaboration

Effective Communication

Education

Bachelor’s degree in biomedical or 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:

1. Clinical Operations point of contact for execution of clinical studies in compliance with ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/Work Instructions.
2. Manage clinical CRO(s) and other study vendors from initial contact through to final study deliverables.
3. Lead external (CRO) trial management team, to ensure conduct in accordance with State and Federal regulations, GCP regulations, ICH guidelines, and internal SOPs.
4. 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.
5. Provide operational input into study documents including clinical protocol, informed consent, CRFs, any and all CRO study documents/study plans.
6. Develop, manage, and maintain study deliverables [i.e. timelines, study plans, etc.] through collaboration with internal and external stakeholders.
7. Proactively identify potential study risks and develop/implement actions to avoid or mitigate potential risks.
8. 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.
9. Attend (in person and virtual) study site visits, such as pre-study selection visits, site initiation visits, and PI engagement meetings.
10. Responsible for supporting the management, oversight and maintenance of the Trial Master File (TMF) held by the CRO.

Qualifications:

1. Bachelor’s degree, or equivalent, in a biomedical, life science or related field of study.
2. 5-8+ years of trial management experience as primary Clinical Trial Manager (or equivalent) within Pharma, Biotech or CRO; Oncology experience required.
3. Strong understanding of global regulatory and compliance requirements for clinical research.
4. Strategic understanding of how outcomes, budgets, and timelines are impacted by decisions.
5. Outstanding teamwork, organizational, interpersonal, and problem-solving skills.
6. Effective communicator both verbally and in written form.
7. Ability to influence and collaborate well with colleagues and partners in a fast-paced growing development company.

Please note: This role is based out of our Watertown, MA office and is not a remote role.