Sr Manager, Clinical Data Management

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

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Job Description

Senior Manager, Clinical Data Management (CDM) is primarily an oversight role, working cross-functionally with internal and external partners to support our efforts in this fast-growing and important area of cell therapy. The role will report to the Associate Director, CDM or higher.

The Senior Manager, CDM will be responsible for leading and overseeing all aspects of clinical data management for Kite sponsored Non-Interventional Studies (NIS) and provide support and expertise on non-Kite sponsored collaborative and Investigator Sponsored Research (ISR), where needed, with guidance from the Associate Director, CDM or Director, CDM. The Senior Manager, CDM will be the lead representative working with cross-functional teams such as Clinical Operations, Translational Medicine, Safety, Biometrics, Clinical Development, Medical Affairs, and Regulatory, as necessary.

This position may be responsible for managing data managers and data management associates, overseeing CDM vendors (external and/or CRO), overseeing the creation of project timelines and data management documentation to ensure effective study delivery across the program.

Responsibilities (include but are not limited to)

Drive and execute the management of CDM deliverables within the Kite sponsored NIS program (including Post-Marketing Required (PMR) studies and Expanded Access Programs (EAP)), in coordination with internal and external cross-functional teams

Provide support and expertise on non-Kite sponsored collaborative and Investigator Sponsored Research (ISR), where needed

Contribute to defining the Kite CDM strategy and processes for these types of studies

Build strong working relationships with Clinical Operations, Medical Affairs, and Translational Medicine to understand upcoming study requirements and provide effective study oversight

Recognizing the effects of study-level decisions at the Program Level and proactively communicating to the wider study team

Provide functional area expertise and guidance during study initiation and conduct, including during protocol design and input into operating model expectations

Communicate efficiently with the CRO counterpart (as needed) to define expectations, set DM timelines and oversee the study status and activities

Works collaboratively with Clinical and Statistical Programming, Clinical Operations, Medical Affairs, Translational Medicine, Biostatistics and other study team members to meet project deliverables and timelines

Anticipate obstacles and difficulties of stakeholders and staff and acts upon them in order to meet team goals

Review and manage the eTMF for completeness and accuracy, ensuring inspection readiness, as applicable