Anya Mordehai

Clinical Trial Manager @Nektar Therapeutics

San Francisco, CA, US

Accountable for ensuring clinical trial activities and deliverables are completed on-time, within budget, and in a highly dynamic and complex environment in accordance with appropriate quality standards including GCP/ICH requirements and SOPs. Manage essential duties and responsibilities as independently as possible. Contributes to and supports the company’s research and development efforts to create high value therapeutics to address unmet medical needs. Oversee and manage all aspects of a clinical trial in accordance with SOPs, ICH/GCP regulations and study-specific manuals and procedures. Lead Study Management Team(s), including cross-functional team(s), CRO(s) and third-party vendors as applicable. Develop and manage effective relationships with key study stakeholders. Responsible for key study quality metrics. Assist in identification, evaluation and hiring of appropriate CROs and other study vendors in accordance with SOPs. Management of CROs and other third party vendors, including setting expectations, training, managing timelines and deliverables, and issue management. Managing assigned vendor budget(s). In collaboration with the Study Management Team, identify risks to study and develop risk mitigation plans, including communication with senior management.Write or contribute to preparation of clinical protocols, informed consent forms, study manuals, case report forms, and other clinical research related documents. Ensure clinical data are reviewed in accordance with study data review plans and that a final, clean dataset is provided upon database lock. Project and coordinate study supply and packaging requirements. Manage expert consultant activities for study related activities, including effective communication. Identify program/resource gaps and proposes solutions. Provide weekly enrollment and program updates to senior management. Lead or participate in functional initiatives and/or activities as assigned.

San Francisco State University

BS Cell & Molecular Biology, Biology, General