Sr Manager, Clinical Data Management

Kite Pharma, Inc.; Santa Monica (CA); Híbrido; USD 143 000 - 185 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Discretionary bonus

Stock options

Paid time off

Medical insurance

Dental insurance

Vision insurance

Resumo da oferta

Kite Pharma, Inc. is seeking a Senior Manager, Clinical Data Management to oversee data management for Kite-sponsored non-interventional studies and ISR collaborations.

The role partners with Clinical Operations, Biostatistics and Medical Affairs to ensure timely, compliant data delivery. Responsibilities include leading CDM deliverables, managing data managers and CRO vendors, ensuring data integrity and audit readiness, and shaping CDM processes across programs.

Qualificações

• Bachelor's degree or higher required with relevant clinical data management experience.
• Experience leading CDM deliverables for NIS or ISR programs.
• Strong knowledge of CDISC standards (CDASH/SDTM/ADaM) and regulatory expectations.
• Proven project management and cross-functional leadership skills.

Responsabilidades

• Lead and oversee all CDM deliverables for Kite-sponsored NIS programs.
• Coordinate with Clinical Operations, Medical Affairs, Translational Medicine and Biostatistics.
• Manage CDM timelines, data management documentation and vendor oversight.
• Ensure data integrity, regulatory compliance and audit readiness across studies.

Conhecimentos

Leadership

CDM

Project management

Cross-functional

Regulatory knowledge

Communication

CDISC standards

Formação académica

Bachelor's degree

Masters' degree

PhD/PharmD

High School diploma

Ferramentas

Medidata Rave

Veeva EDC

Medrio EDC

Oracle

TrialGrid

Descrição da oferta de emprego

Sr Manager, Clinical Data Management### Sr Manager, Clinical Data ManagementApply: Remote: United States – Remote: Full time: Posted Yesterday: R0055878We’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 DescriptionSenior 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 experienceORBachelor's Degree and Eight Years' ExperienceORMasters' Degree and Six Years' ExperienceORPhD / 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 ecosystemThe 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\\*.For additional benefits information, visit:https://www.gilead.com/careers/compensation-benefits-and-wellbeing\\* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.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.