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 to Clinical Development leadership, relationship management between study sites and vendors (in particular CROs), supervision of study related activities, identification of project risks and contingency planning.
Responsibilities:
- Clinical Operations 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 the successful 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 such as 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
- Minimum of 5 years of trial management experience as primary Clinical Trial Manager (or equivalent) within Pharma, Biotech or CRO; Oncology experience required.
- Good understanding of global regulatory and compliance requirements for clinical research
- Solid teamwork, organizational, interpersonal, and problem-solving skills
- Critical thinking skills for problem solving and have the strategic thinking capacity to drive the study(ies) and understands the implications of decisions that affect study outcomes, budgets and timelines.
- Can effectively communicate both verbally and in written form
- Ability to influence and collaborate well with colleagues and partners in a fast-paced growing development company
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