Sr Manager, Clinical Data Management

Gilead SciencesUnited States – Remoteremote$143k–$185kView the original posting at Gilead Sciences ↗

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. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows. 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 Oversight of study documentation, ensuring timely completion and ongoing adherence to regulatory expectations, relating to data integrity and patient safety Serve as a primary point of contact for internal and external study team members Oversee the completeness, accuracy, and consistency of clinical data and data structure across the program on an ongoing basis Perform management of CDM deliverables as described or provides oversight and guidance to Dat

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