
Senior Manager, Clinical Programming
United States – RemoteClinical Development & Clinical OperationsRegularJob Description
Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Would you like to join us in this mission?
We are seeking a highly motivated individual to join us as a Senior Manager, Clinical Programming. 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 study support resource reporting to the Executive Director, Clinical Data Management.
The Senior Manager, Clinical Programming will be responsible for overseeing all aspects of database build and data reporting support for Kite’s clinical development programs with guidance from the Senior Data Management Staff. This position will be responsible for building clinical databases, performing migrations, programming quality reports, and assisting with the technical aspects of clinical databases necessary for clinical data collection, and data review. The Senior Manager, Clinical Programming will also be responsible for data reporting work on detailed data review for clinical trials.
Responsibilities of the Senior Manager, Clinical Programming include, but are not limited to the following:
- Build RAVE databases for new protocols
- Perform Database Migrations for all Kite studies
- Assist with standardization of Case Report Forms including SAS naming conventions for all data received (external and clinical database)
- Build and support data review reports in Data Reporting tool (e.g., JReview)
- Assist with clinical data management data review tasks, as needed
- EDC and Reporting technical Representative in the study teams
- Project level coordination and day to day oversight
- Manage EDC vendor for any issue resolution
- Lead EDC and Reporting deliverables in coordination with internal and external cross functional teams
- Support CDM on Study timeline and database snapshot coordination for analysis including Safety Review
Basic Requirements:
- PhD OR
- MS/MA in life sciences or related discipline and 6+ years of experience in Clinical Programming OR
- BS/BA in life science or related discipline and 8+ years of experience in Clinical Programming OR
- High School degree and 12+ years of experience in Clinical Programming
Preferred Requirements:
- Demonstrated knowledge of FDA, EMA, ICH guidelines and regulations covering clinical trials, statistics, and data management
- Experience with Medidata RAVE including database build, edit check programming, data extraction, and migrations
- Understanding of data standards (CDISC, CDASH) in the clinical trial environment
- Experience with SAS programming, preferred
- Experience with Spotfire and/or JReview programming, preferred
- Excellent verbal and written communication skills, including the ability to clearly describe critical technical CDM aspects to non-CDM staff
- 10+ years technical experience in clinical development
- Flexible to changing priorities, detail-oriented, works well under pressure, and able to take on unfamiliar tasks