Sr Manager, Clinical Data Management

Kite Pharma; Oregon; Hybride; USD 143 000 - 185 000; Plein temps

Résumé du poste

Kite Pharma, Inc. is seeking a Senior Manager, Clinical Data Management (CDM) to oversee data management for Kite-sponsored non-interventional studies and ISR collaborations, reporting to the Associate Director, CDM or higher.

The role will manage data managers, CROs, project timelines, and data documentation, ensuring regulatory compliance and study delivery across programs worldwide.

Qualifications

• Bachelor's degree required with 8+ years CDM experience.
• Masters' degree preferred with 6+ years in data management.
• PhD/PharmD or equivalent highly regarded for senior leadership.

Responsabilités

• Oversee CDM deliverables for Kite-sponsored NIS studies.
• Provide guidance on ISR and collaboration studies as needed.
• Lead CDM process development and regulatory-ready documentation.
• Coordinate with CROs and internal stakeholders to ensure data integrity.

Connaissances

CDM oversight

Cross-functional

Project management

Medidata Rave

EDC tools

Formation

High School degree

Bachelor's Degree

Masters' Degree

PhD / PharmD

Outils

Medidata Rave

Veeva EDC

Medrio EDC

Oracle

Description du poste

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.

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

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 teamsProvide support and expertise on non-Kite sponsored collaborative and Investigator Sponsored Research (ISR), where neededContribute to defining the Kite CDM strategy and processes for these types of studiesBuild strong working relationships with Clinical Operations, Medical Affairs, and Translational Medicine to understand upcoming study requirements and provide effective study oversightRecognizing the effects of study-level decisions at the Program Level and proactively communicating to the wider study teamProvide functional area expertise and guidance during study initiation and conduct, including during protocol design and input into operating model expectationsCommunicate efficiently with the CRO counterpart (as needed) to define expectations, set DM timelines and oversee the study status and activitiesWorks collaboratively with Clinical and Statistical Programming, Clinical Operations, Medical Affairs, Translational Medicine, Biostatistics and other study team members to meet project deliverables and timelinesAnticipate obstacles and difficulties of stakeholders and staff and acts upon them in order to meet team goalsReview and manage the eTMF for completeness and accuracy, ensuring inspection readiness, as applicableOversight of study documentation, ensuring timely completion and ongoing adherence to regulatory expectations, relating to data integrity and patient safetyServe as a primary point of contact for internal and external study team membersOversee the completeness, accuracy, and consistency of clinical data and data structure across the program on an ongoing basisPerform management of CDM deliverables as described or provides oversight and guidance to Data Manager leading CDM deliverablesLead CDM representative during internal audits as well as Health Authority auditsLead the development, review, and implementation of processes, policies, SOPs, and associated documents affecting CDM and cross-functional groupsLead and/or participate in CDM cross-functional initiativesProactively provide input into CDM organizational strategy and implements departmental changeProactively provide input to continuous improvement activities within Clinical Data Management and leads the relevant support for implementationFlexible to changing priorities, detail-oriented, works well under pressure, and able to take on unfamiliar tasksPrioritize and effectively delegate study and initiative responsibilitiesAssume expanded scope of responsibility with respect to volume and complexity of clinical project work as well as direct report responsibilityTo 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 WHODDHave excellent verbal and written communication skills, including the ability to clearly describe critical technical CDM aspects to non-CDM staffExperienced project management skillsTraining and mentoring of all roles in CDMCommunication 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

Compensation

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*. For additional benefits information, visit:careers/compensation-benefits-and-wellbeing* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

Company Information

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.

Equal Employment Opportunity

For jobs in the United States: Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or