Sr Manager, Clinical Data Management

Gilead Sciences

2d • $143,225 - $185,350

About The Position

The Senior Manager, Clinical Data Management (CDM) is primarily an oversight role supporting Kite-sponsored Non-Interventional Studies (NIS) and providing expertise, as needed, for non-Kite-sponsored collaborative studies and Investigator Sponsored Research (ISR). The role leads and oversees clinical data management activities across the program and works with internal and external partners, including Clinical Operations, Translational Medicine, Safety, Biometrics, Clinical Development, Medical Affairs, and Regulatory. The position reports to the Associate Director, CDM, or higher.

The role may manage data managers and data management associates, oversee external and CRO vendors, and manage project timelines and documentation to support effective study delivery. The Senior Manager contributes to CDM strategy and processes, provides functional guidance from study initiation through conduct, ensures data quality and documentation readiness, and represents CDM in audits and cross-functional initiatives. The position may carry direct-report responsibilities and expanded responsibility for the volume and complexity of clinical projects.

Kite is a biopharmaceutical company developing cancer immunotherapies, including CAR and TCR engineered cell therapies. The position offers a salary range of $143,225 to $185,350 and may be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and company-sponsored medical, dental, vision, and life insurance plans.

Requirements

• High school degree and 12 years of experience; or bachelor's degree and 8 years of experience; or master's degree and 6 years of experience; or PhD/PharmD.
• Proficiency with web-based Electronic Data Capture systems, such as Medidata Rave and other clinical data management systems.
• Experience with industry thesauri and dictionaries, such as MedDRA and WHODD.
• Excellent verbal and written communication skills, including the ability to explain critical technical CDM topics to non-CDM staff.
• Project management skills.
• Ability to work flexibly amid changing priorities, with attention to detail and effectiveness under pressure.
• Ability to prioritize and delegate responsibilities.
• Ability to train and mentor CDM personnel.

Nice To Haves

• Experience independently leading 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 and a successful record of leading through influence across complex, global organizational matrices.
• Experience with industry standards guidelines such as CDISC, including CDASH, SDTM, or ADaM models.
• Strong knowledge of leading EDC tools such as Medidata Rave, Veeva EDC, Medrio EDC, Oracle, or TrialGrid, and familiarity with industry trends and emerging data-collection technologies.
• Experience interpreting Health Authority regulations and GCP/ICH guidelines, with a strong compliance background.
• Strong working knowledge of the pharmaceutical development process.
• Influential leadership and communication capabilities, with a proven ability to engage, manage, develop, and inspire a geographically diverse team.

Responsibilities

• Drive and execute clinical data management deliverables for Kite-sponsored NIS programs, including Post-Marketing Required studies and Expanded Access Programs, in coordination with internal and external cross-functional teams.
• Provide support and expertise for non-Kite-sponsored collaborative studies and Investigator Sponsored Research, as needed.
• Contribute to defining Kite CDM strategy and processes for these study types.
• Build working relationships with Clinical Operations, Medical Affairs, and Translational Medicine to understand study requirements and provide effective oversight.
• Recognize the program-level effects of study decisions and communicate them proactively to the wider study team.
• Provide functional expertise and guidance during study initiation and conduct, including protocol design and operating model expectations.
• Coordinate with CRO counterparts, as needed, to define expectations, establish data management timelines, and oversee study status and activities.
• Collaborate with Clinical and Statistical Programming, Clinical Operations, Medical Affairs, Translational Medicine, Biostatistics, and other study team members to meet deliverables and timelines.
• Anticipate stakeholder and staff obstacles and act to support team goals.
• Review and manage the eTMF for completeness, accuracy, and inspection readiness, as applicable.
• Oversee study documentation for timely completion and ongoing compliance with regulatory expectations related to data integrity and patient safety.
• Serve as a primary contact for internal and external study team members.
• Oversee clinical data and data structure across the program for completeness, accuracy, and consistency.
• Manage CDM deliverables or provide oversight and guidance to the Data Manager leading them.
• Lead the CDM function during internal and Health Authority audits.
• Lead development, review, and implementation of processes, policies, SOPs, and related documents affecting CDM and cross-functional groups.
• Lead or participate in CDM cross-functional initiatives.
• Provide input into CDM organizational strategy and implement departmental change.
• Contribute to continuous improvement activities within CDM and lead relevant implementation support.
• Adapt to changing priorities, work effectively under pressure, and take on unfamiliar tasks.
• Prioritize and delegate study and initiative responsibilities effectively.
• Assume expanded responsibility for clinical project volume and complexity, including direct reports where applicable.
• Use web-based electronic data capture systems and industry thesauri and dictionaries.
• Train and mentor personnel in CDM roles.
• Communicate and escalate project-level issues concerning processes, timelines, resourcing, and performance.
• If responsible for direct reports, oversee their development.

Benefits

• Potential eligibility for a discretionary annual bonus.
• Potential eligibility for discretionary stock-based long-term incentives; eligibility may vary by role.
• Paid time off.
• Company-sponsored medical insurance.
• Company-sponsored dental insurance.
• Company-sponsored vision insurance.
• Company-sponsored life insurance.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: High school or GED