Manager, Clinical Data Management
Kite Pharma•Santa Monica, CA
•$123,930 - $160,380
About The Position
The Manager, Clinical Data Management (CDM) will be a hands-on 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 Senior Manager, CDM or higher.
Requirements
- MS/MA in life sciences or related discipline and 4+ years of experience in Data Management OR BS/BA in life science or related discipline and 6+ years of experience in Data Management OR High School degree and 10+ years of experience in Data Management
Nice To Haves
- Experience as independent lead in managing clinical data management deliverables for regulatory filings
- At least 6 years of relevant industry experience with clinical trials and a successful track record of leading through influence, working across complex, global organizational matrices
- Experience in Industry Standards Guidelines (e.g., CDISC) in either the collection (CDASH), tabulation (SDTM), or analysis (ADaM) models
- Strong knowledge of industry-leading EDC tools (e.g., Medidata Rave, Veeva EDC, Medrio EDC, Oracle, TrialGrid, etc.) and well versed in industry trends and emerging technologies supporting data collection
Responsibilities
- Lead the management of CDM deliverables in coordination with internal and external cross-functional teams
- Lead by providing CDM expertise for data coordination, collection, and cleaning to efficiently ensure high quality data
- Perform the execution of end-to-end Data Management activities (e.g., eCRF development, Data Review, study lock) for multiple studies across therapeutic areas and/or indications
- Develop and manage data management timelines to ensure study goals and activities are met
- Oversee External Data Management activities by providing project level support of External Data Management tasks (development of Data Transfer Plans, coordination of file transfers to meet study deliverables etc.)
- Anticipate obstacles and difficulties of stakeholders and staff and acts upon them or escalates accordingly in order to meet team goals
- Manage the development and finalization of CDM documents to be filed in the eTMF
- Review and manage the eTMF for completeness and accuracy, ensuring inspection readiness
- Serve as a primary point of contact for internal and external study team members in relation to all Data Management activities
- Ensure completeness, accuracy, and consistency of clinical data and data structure across all projects on an ongoing basis
- Responsible for data review, query management, and metric report delivery to study teams
- Coordinate study timelines and database snapshots for analysis and safety review meetings
- Participate in and/or represent CDM during internal audits as well as Health Authority audits and inspections
- Participate in the development, review, and implementation of processes, policies, SOPs, and associated documents affecting CDM
- Participate in CDM and cross-functional initiatives
- Proactively provides input to continuous improvement activities within Clinical Data Management and provides the relevant support for implementation
- Flexible to changing priorities, detail-oriented, works well under pressure, and able to take on unfamiliar tasks
- Demonstrates an ability to prioritize and delegate effectively
- Demonstrates ability to assume expanded scope of responsibility with respect to volume and complexity of clinical project work
- Works collaboratively with Clinical and Statistical Programming, Clinical Operations, Biostatistics, and others study team members to meet project deliverables and timelines
- Demonstrates proficiency with web-based Electronic Data Capture (such as Medidata Rave and other clinical data management systems)
- Experienced with industry wide thesauri/dictionaries such as MedDRA and WHODD
- Demonstrates excellent verbal and written communication skills, including the ability to clearly describe critical technical CDM aspects to non-CDM staff
- Training and mentoring of junior CDM staff
- Communication and escalation of project level issues including processes, timelines, resourcing, performance, etc.
- May have direct report responsibilities including oversight and development
Benefits
- company-sponsored medical, dental, vision, and life insurance plans
- discretionary annual bonus
- discretionary stock-based long-term incentives
- paid time off
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
No Education Listed
