Senior Manager, Clinical Programming- Clinical Data Standards Management
Kite Pharma · NAMER
- Remote
- Full-time
- $175,000 / year
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Job highlights
- Develop global clinical data standards.
- Utilize CDISC SDTM and controlled terminology.
- Manage library objects and resolve issues.
- Act as SME for operational data standards.
- Lead strategic initiatives and provide training.
About the role
About Kite Pharma
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
Responsibilities include but are not limited to:
- Participate in the development and maintenance of global clinical data standards, including operational (eCRF and non-eCRF (e.g., lab, Imaging, or ECG)) data mappings.
- To develop operational mappings, utilize Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM), controlled terminology, and other applicable industry standards.
- Manage work assignments to ensure timely delivery of global library objects.
- Identify and resolve issues that may negatively impact the delivery of global library objects and escalate to leadership as needed.
- Serve as a Subject Matter Expert (SME) on operational data standards utilizing SDTM standards and CDISC controlled terminology in developing operational data standards.
- Support and participate in the Standards Core Committee (SCC).
- Partner with functional area stewards.
- Organize standards topics to be reviewed and ensure decisions are made on time.
- Document meeting minutes and other discussions.
- Provide input and information to facilitate critical discussions and decisions regarding standards use and implementation.
- Support preparation of materials for the Standards Governance Committee (SGC) and address all comments received until all objects in scope get approved.
- Build, maintain, and document Medidata Rave global library standard objects (e.g., eCRF forms, edit checks) to facilitate the creation of study-level databases.
- Work with Data Managers and EDC Programmers to implement new or modified global library objects (e.g., ensure DM and EDCP clearly understand global library objects).
- Build and maintain CRF Completion Guidelines for all standard forms.
- Follow procedural documents and participate in reviewing and updating documents to ensure they reflect industry standards and are easily followed.
- Communicate and reinforce content and interpretation of Kite data standards to project and study teams to ensure consistency in understanding and implementing standards across a project.
- Participate in relevant study and project team meetings as a standards SME and provide input for standards components, such as CRF design, CRF Completion Guidelines, programmed edit checks, Data transfer specifications, mapping specifications, and annotated CRF.
- Contribute to developing and applying smart systems and optimal approaches to support data collection.
- Independently identify and propose process improvements while maintaining a strategic focus.
- Share new industry standards and best practices with project and study teams and departments as required.
- Liaise with and review work delivered by external partners (e.g., Function Service Providers, CROs, technology providers, etc.).
- Develop strong and productive working relationships with key stakeholders throughout CDMs, Clinical Ops, and Kite with the ability to think strategically across a broad portfolio and effectively express their views to senior management.
- Participate and/or lead in strategic initiatives, special projects, and working groups contributing to business decisions and process changes.
- Participate and/or lead in developing Global Clinical Data Standards and other cross-functional SOPs, Working Procedures, Guidance documents, and job aids.
- Participate and/or lead in identifying, reviewing, evaluating, and implementing new data standards-related technologies.
- Develop training materials and provide training on CDSM and GLIB-developed processes.
- Provide mentoring, coaching, and escalation support to more junior personnel or contract staff, as required.
- Represent the Company in interactions with key external partners as part of any committee or industry group.
Requirements:
- PhD in life sciences or related discipline and 2+ years of experience OR
- MS/MA in life sciences or related discipline and 6+ years of experience in Clinical Data Standards OR
- BS/BA in life science or related discipline and 8+ years of experience in Clinical Data Standards OR
- High School degree and 12+ years of experience in Clinical Data Standards
Preferred Qualifications:
- MS/MA in life sciences or related discipline and 4+ years of experience in Clinical Data Standards
- 6+ 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 (e.g., CDISC) in either the collection (CDASH), tabulation (SDTM), or analysis (ADaM) models.
- At least 8 years of clinical database developer experience in Rave with expertise in global library development and development of standard data collection objects.
- Strong understanding of the drug development process with proven expertise in clinical trial execution and global library development/clinical database development in a global arena.
- Strong knowledge of industry-leading EDC tools (e.g., Medidata Rave, Veeva, Medrio, Oracle, TrialGrid, etc.) and well-versed in industry trends and emerging technologies supporting data collection.
- Understanding of database and dictionary structures (e.g., MedDRA, WHODrug).
- Experience interpreting Health Authority regulations and GCP/ICH guidelines with a strong compliance background.
- Strong working knowledge of the overall pharmaceutical development process.
- Strong working knowledge of SDTM and creating data mapping specifications and annotated CRFs.
- Knowledge of requirements of define.xml.
- Experience in CRF design, query resolution, and general data validation.
- Technical expertise, technical writing ability, and proficiency in Systems Development Life Cycle (SDLC) principles.
- Excellent verbal and written communication skills, high ability to communicate standards-related issues, options, and their impact to project teams and within the department.
- Diverse and sufficient technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory & quality, etc.).
- Influential leadership and communication capabilities with a proven ability to engage, manage, develop and inspire a geographically diverse team.
Compensation
The salary range for this position is: $153,935.00 - $199,210.00. 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.
About Kite Pharma
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
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.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
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.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Kite Pharma Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
Key skills/competency
- Clinical Data Standards Management
- CDISC SDTM
- Medidata Rave
- Clinical Data Management
- Life Sciences
- Data Collection
- Process Improvement
- Regulatory Compliance
- Technical Writing
- Leadership
Skills & topics
- Senior Manager
- Clinical Data Standards
- Data Management
- CDISC
- SDTM
- Medidata Rave
- Clinical Trials
- Biopharmaceutical
- Oncology
- Leadership
How to get hired
- Tailor your resume: Highlight experience with CDISC, SDTM, and Medidata Rave.
- Quantify achievements: Use numbers to show impact in clinical data standards.
- Showcase leadership: Emphasize experience leading teams and projects.
- Prepare for technical questions: Be ready to discuss data standards and regulations.
- Understand Kite's mission: Align your application with their goal to cure cancer.
Technical preparation
Behavioral questions
Frequently asked questions
- What are the key industry standards for clinical data management at Kite Pharma?
- Kite Pharma emphasizes the use of industry standards such as CDISC Study Data Tabulation Model (SDTM) and controlled terminology. They also utilize CDASH for data collection and ADaM for analysis. Experience with these standards is crucial for success in the Senior Manager, Clinical Data Standards Management role.
- What specific EDC tools are important for this Senior Manager role?
- Medidata Rave is a critical EDC tool mentioned for this role, particularly for global library development and standard data collection objects. Familiarity with other industry-leading EDC tools like Veeva, Medrio, or Oracle is also beneficial.
- What is the expected experience level for a Senior Manager, Clinical Data Standards Management at Kite Pharma?
- Kite Pharma requires a minimum of a PhD with 2+ years of experience, or an MS/MA with 6+ years, or a BS/BA with 8+ years in Clinical Data Standards. Preferred qualifications include an MS/MA with 4+ years and overall 6+ years of industry experience with clinical trials.
- How does Kite Pharma approach clinical trial execution and data collection?
- Kite Pharma focuses on developing innovative cancer immunotherapies. For clinical trials, they leverage industry standards, EDC tools like Medidata Rave, and robust data management processes to ensure data quality and support the drug development lifecycle, aiming for rapid, long-term durable responses.
- What opportunities are there for career growth in clinical data standards at Kite Pharma?
- As a Senior Manager, you will have opportunities to lead strategic initiatives, mentor junior staff, and represent the company in external committees. Kite Pharma's commitment to evolving medical science suggests a dynamic environment for career advancement within clinical data standards management.
- What is the role of CDISC in Kite Pharma's clinical data standards?
- CDISC standards, specifically SDTM and controlled terminology, are fundamental to Kite Pharma's clinical data standards management. They are used for developing operational data mappings and ensuring consistency across global library objects and study databases.
- How does Kite Pharma foster an inclusive work environment?
- Kite Pharma is committed to equal employment opportunities and fostering an inclusive work environment with diverse perspectives. They prohibit discrimination and encourage a culture that respects individual differences and celebrates the unique contributions of their team members.