We’re seeking a Senior Clinical Trial Manager with relevant clinical operations experience to join our Clinical Development group. Reporting to the Senior Director of Clinical Operations, the successful candidate will be responsible for providing trial management support for our oncology immunotherapy programs. Job responsibilities include, but are not limited to, preparation of study related materials, relationship management between study sites and vendors (in particular CROs), supervision of study related activities, identification of project risks and contingency planning. The successful candidate will excel in a highly collaborative work environment with a multi-disciplinary and diverse team. The work will be fast paced with evolving needs, requiring adaptability, curiosity, and grace under pressure.
- Primary operational contact for execution of the study in compliance with ICH/GCP, Regulatory Authorities’ regulations/guidelines, and applicable SOPs/Work Instructions
- Development, management, maintenance of study deliverables [i.e. timelines, study plans, etc.] through collaboration with internal and external stakeholders
- Proactive identification of potential risks and development/implementation of actions to avoid or mitigate
- Operational input into study documents such as synopsis, protocol, Informed Consent, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plan, etc.
- Participation in clinical service provider (vendor) selection, specification development, and management/oversight
- Development/coordination of study training and materials for study team, investigational sites, and vendors in collaboration with medical and scientific colleagues
- Lead both an internal and external/CRO trial management team, to ensure the successful conduct in accordance with State and Federal regulations, GCP regulations, ICH guidelines, and internal SOPs
- Contribute to development of proactive strategy and corrective action plan to address trial issues in collaboration with cross functional team
- Responsible for supporting the management, oversight and maintenance of the Trial Master File (TMF) held by the CRO
- Bachelor’s degree, or equivalent, preferably in a biomedical, life science or related field of study
- Minimum of 5 years of progressively increasing clinical trial management experience within the Pharma, Biotech or CRO; Oncology/Immuno-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 environment