Sr Manager, Clinical Data Management

Gilead Sciences Inc.; United States; Remote; USD 143,000 - 185,000; Full time

Job summary

Kite Pharma seeks a Senior Manager, CDM to oversee data management for NIS studies and support Investigator Sponsored Research. You will lead cross-functional teams, ensure data integrity, and drive timelines across internal and vendor partners.

Ideal candidates bring 10+ years in clinical data management with CDISC standards, strong leadership, and experience with major EDC systems. This role emphasizes regulatory readiness and collaboration across Clinical Operations and Medical Affairs.

Qualifications

• Lead in clinical data management deliverables for regulatory filings
• Experience managing NIS studies in an oversight capacity
• 10+ years of industry experience in clinical trials and leadership through influence
• Experience with CDISC standards (CDASH/SDTM/ADaM)

Responsibilities

• Drive and execute management of CDM deliverables within Kite sponsored NIS program.
• Provide support on non-Kite sponsored collaborative and ISR studies.
• Define Kite CDM strategy and processes for these studies.
• Build relationships with Clinical Operations, Medical Affairs, Translational Medicine to understand study requirements.
• Communicate DM timelines and oversee study status with CRO counterparts.
• Lead CDM representatives during internal and Health Authority audits.
• Develop and implement CDM processes, SOPs, and related documents.
• Mentor and train CDM roles; participate in cross-functional initiatives.

Skills

CDM leadership

Cross-functional collaboration

Project management

Communication

Mentoring

Education

Bachelor's Degree (or higher) in a related field

Masters' Degree (optional)

PhD / PharmD (preferred)

High School diploma with extensive experience

Tools

Medidata Rave

Veeva EDC

Medrio EDC

Oracle

TrialGrid

Job description

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

Job Description

Senior Manager, Clinical Data Management (CDM) is primarily an oversight 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 Associate Director, CDM or higher.

The Senior Manager, CDM will be responsible for leading and overseeing all aspects of clinical data management for Kite sponsored Non-Interventional Studies (NIS) and provide support and expertise on non-Kite sponsored collaborative and Investigator Sponsored Research (ISR), where needed, with guidance from the Associate Director, CDM or Director, CDM.

The Senior Manager, CDM will be the lead representative working with cross-functional teams such as Clinical Operations, Translational Medicine, Safety, Biometrics, Clinical Development, Medical Affairs, and Regulatory, as necessary.

This position may be responsible for managing data managers and data management associates, overseeing CDM vendors (external and/or CRO), overseeing the creation of project timelines and data management documentation to ensure effective study delivery across the program.

Responsibilities (include but are not limited to)

• Drive and execute the management of CDM deliverables within the Kite sponsored NIS program (including Post-Marketing Required (PMR) studies and Expanded Access Programs (EAP)), in coordination with internal and external cross-functional teams
• Provide support and expertise on non-Kite sponsored collaborative and Investigator Sponsored Research (ISR), where needed
• Contribute to defining the Kite CDM strategy and processes for these types of studies
• Build strong working relationships with Clinical Operations, Medical Affairs, and Translational Medicine to understand upcoming study requirements and provide effective study oversight
• Recognizing the effects of study‑level decisions at the Program Level and proactively communicating to the wider study team
• Provide functional area expertise and guidance during study initiation and conduct, including during protocol design and input into operating model expectations
• Communicate efficiently with the CRO counterpart (as needed) to define expectations, set DM timelines and oversee the study status and activities
• Works collaboratively with Clinical and Statistical Programming, Clinical Operations, Medical Affairs, Translational Medicine, Biostatistics and other study team members to meet project deliverables and timelines
• Anticipate obstacles and difficulties of stakeholders and staff and acts upon them in order to meet team goals
• Review and manage the eTMF for completeness and accuracy, ensuring inspection readiness, as applicable
• Oversight of study documentation, ensuring timely completion and ongoing adherence to regulatory expectations, relating to data integrity and patient safety
• Serve as a primary point of contact for internal and external study team members
• Oversee the completeness, accuracy, and consistency of clinical data and data structure across the program on an ongoing basis
• Perform management of CDM deliverables as described or provides oversight and guidance to Data Manager leading CDM deliverables
• Lead CDM representative during internal audits as well as Health Authority audits
• Lead the development, review, and implementation of processes, policies, SOPs, and associated documents affecting CDM and cross-functional groups
• Lead and/or participate in CDM cross‑functional initiatives
• Proactively provide input into CDM organizational strategy and implements departmental change
• Proactively provide input to continuous improvement activities within Clinical Data Management and leads the relevant support for implementation
• Flexible to changing priorities, detail-oriented, works well under pressure, and able to take on unfamiliar tasks
• Prioritize and effectively delegate study and initiative responsibilities
• Assume expanded scope of responsibility with respect to volume and complexity of clinical project work as well as direct report responsibility
• To be proficient in 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
• Have excellent verbal and written communication skills, including the ability to clearly describe critical technical CDM aspects to non‑CDM staff
• Experienced project management skills
• Training and mentoring of all roles in CDM
• Communication and escalation of project level issues including processes, timelines, resourcing, performance, etc.
• Potential for direct report responsibility including oversight and development

Basic Qualifications

• High School degree and 12 years of experience
• Bachelor's Degree and Eight Years' Experience
• Masters' Degree and Six Years' Experience
• PhD / PharmD

Preferred Qualifications

• 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 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
• Experience interpreting Health Authority regulations and GCP/ICH guidelines with a strong compliance background
• Strong working knowledge of the overall pharmaceutical development process
• Influential leadership and communication capabilities with a proven ability to engage, manage, develop and inspire a geographically diverse team

People Leader Accountabilities

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving feedback and insight needed to grow, develop and realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem

Salary and Benefits

The salary range for this position is: $143,225.00 - $185,350.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing

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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