Manager, Clinical Data Management

Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job

Job Description

We are seeking a highly motivated individual to join us as a Clinical Data Manager . You will work with the Biostatistics, Programming, and Clinical Operations teams in supporting our efforts in this exciting new area of cancer immunotherapy. This role will be a hands-on resource reporting to the Senior Manager, Clinical Data Management

The Clinical Data Manager will be responsible for overseeing all aspects of external data management for Kite's clinical development programs with guidance from the Senior Manager, CDM. This position will be responsible for clinical data collection and data review. The Clinical Data Manager will also work with Clinical Operations, Safety and Regulatory as necessary.

Responsibilities (include but are not limited to):

• Project level coordination and day to day oversight of External Data Management tasks
• Manage data management timelines to ensure goals of teams are met
• Manage vendors, and ensure appropriate resources are available to meet the demands of the assigned clinical trials
• Provide CDM expertise for external vendor data coordination, collection, and cleaning to efficiently ensure high quality data
• Manage CDM deliverables in coordination with internal and external cross functional teams.
• Review clinical data on an ongoing basis to ensure quality data
• Create Data Transfer Plans and other pertinent External Data documentation
• Review, query management, report delivery to study teams, study timeline and database snapshot coordination for analysis including Safety Review Team, Interim Analysis, etc.
• Flexible to changing priorities, detail-oriented, works well under pressure and able to take on unfamiliar tasks.

Requirements :

• BS/BA with 7+ years of experience in CDM within clinical development - OR - MS/MA with 5+ years of experience in CDM within clinical development
• Scientific background and experience with lab data handling
• Demonstrated knowledge of FDA, EMA, ICH guidelines and regulations covering clinical trials, statistics, and data management
• Experience managing clinical data management deliverables for regulatory filings
• Excellent verbal and written communication skills, including the ability to clearly describe critical technical CDM aspects to non-CDM staff

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.

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For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.