Senior Manager, Clinical Data Management
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Job Description
Clinical data management leader overseeing Kite’s non-interventional and investigator-sponsored studies. Supporting cancer immunotherapy development through CDM strategy, compliance, vendors, and cross-functional delivery.
Responsibilities:
- Lead and oversee all aspects of clinical data management for Kite-sponsored Non-Interventional Studies, including Post-Marketing Required studies and Expanded Access Programs
- Provide support and expertise for non-Kite-sponsored collaborative and Investigator Sponsored Research
- Contribute to Kite CDM strategy and processes
- Build working relationships with Clinical Operations, Medical Affairs, and Translational Medicine
- Communicate study-level decisions and impacts to wider study teams
- Provide functional expertise during study initiation and conduct, including protocol design and operating model expectations
- Define expectations, set data management timelines, and oversee study status and activities with CRO counterparts
- Collaborate with Clinical and Statistical Programming, Clinical Operations, Medical Affairs, Translational Medicine, Biostatistics, and other study team members
- Review and manage the eTMF for completeness, accuracy, and inspection readiness
- Oversee study documentation and adherence to regulatory expectations for data integrity and patient safety
- Serve as primary contact for internal and external study team members
- Oversee clinical data completeness, accuracy, consistency, and data structure across the program
- Manage or oversee CDM deliverables
- Lead CDM representation during internal and Health Authority audits
- Lead development, review, and implementation of CDM processes, policies, SOPs, and related documents
- Lead or participate in CDM cross-functional initiatives
- Provide input into CDM organizational strategy and implement departmental change
- Lead continuous improvement support and implementation within Clinical Data Management
- Prioritize and delegate study and initiative responsibilities
- Assume expanded responsibility for clinical project volume, complexity, and direct reports
- Manage data managers and data management associates, oversee CDM vendors, and oversee project timelines and data management documentation
- Train and mentor CDM staff
- Communicate and escalate project-level issues involving processes, timelines, resourcing, and performance
- Potentially oversee and develop direct reports
Requirements:
- High School degree and 12 years of experience OR Bachelor's Degree and Eight Years' Experience OR Masters' Degree and Six Years' Experience OR PhD / PharmD
- Experience as independent lead in managing clinical data management deliverables for regulatory filings
- Experience managing NIS studies in an oversight capacity
- At least 10 years of relevant industry experience with clinical trials
- Successful track record of leading through influence and working across complex, global organizational matrices
- Experience with Industry Standards Guidelines, including CDISC, CDASH, SDTM, or ADaM
- Strong knowledge of industry-leading EDC tools such as Medidata Rave, Veeva EDC, Medrio EDC, Oracle, or TrialGrid
- Experience interpreting Health Authority regulations and GCP/ICH guidelines
- Strong working knowledge of the overall pharmaceutical development process
- Proficiency in web-based Electronic Data Capture and clinical data management systems
- Experience with industry-wide thesauri/dictionaries such as MedDRA and WHODD
- Experienced project management skills
- Excellent verbal and written communication skills
- Training and mentoring experience in Clinical Data Management
- Ability to communicate and escalate project-level issues
- Flexible to changing priorities, detail-oriented, works well under pressure, and able to take on unfamiliar tasks
- Ability to prioritize and effectively delegate responsibilities
Benefits:
- Discretionary annual bonus
- Discretionary stock-based long-term incentives
- Paid time off
- Company-sponsored medical insurance
- Company-sponsored dental insurance
- Company-sponsored vision insurance
- Company-sponsored life insurance
- Benefits package
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