Senior Manager, Clinical Data Management - CDM Lead

Kite Pharma, Inc.; United States; Remote; USD 120,000 - 190,000; Full time

Job summary

Kite Pharma, Inc. in the United States is seeking a Senior Manager, Clinical Data Management (CDM) to oversee all data management activities for Kite-sponsored non-interventional studies, and to support ISR and collaborations as needed.

The role reports to the Associate Director, CDM or higher, and works with Clinical Operations, Translational Medicine, Safety, Biostatistics, and Regulatory to ensure timely study delivery.

Responsibilities

• 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

Job description

Kite Pharma, Inc. in the United States is seeking a Senior Manager, Clinical Data Management (CDM) to oversee all data management activities for Kite-sponsored non-interventional studies, and to support ISR and collaborations as needed.

The role reports to the Associate Director, CDM or higher, and works with Clinical Operations, Translational Medicine, Safety, Biostatistics, and Regulatory to ensure timely study delivery.