Sr Manager, Clinical Data Management

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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

OR

Bachelor's Degree and Eight Years' Experience

OR

Masters' Degree and Six Years' Experience

OR

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

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.
 

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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 other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.

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Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the  legal duty to furnish information; or (d) otherwise protected by law.
 

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