Sr Manager, Clinical Data Management

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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

• 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 Data Manager leading CDM deliverables

• Lead CDM representative during internal audits as well as Health Authority audits

• Lead the development, review, and implementation of processes, policies, SOPs, and associated documents affecting CDM and cross-functional groups

• Lead and/or participate in CDM cross-functional initiatives

• Proactively provide input into CDM organizational strategy and implements departmental change

• Proactively provide input to continuous improvement activities within Clinical Data Management and leads the relevant support for implementation

• Flexible to changing priorities, detail-oriented, works well under pressure, and able to take on unfamiliar tasks

• Prioritize and effectively delegate study and initiative responsibilities

• Assume expanded scope of responsibility with respect to volume and complexity of clinical project work as well as direct report responsibility
• To be proficient in web-based Electronic Data Capture (such as Medidata Rave and other clinical data management systems)

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