Clinical Data Management Manager

Kite Pharma • Santa Monica, CA

1d

About The Position

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 At Gilead/Kite our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As a Manager, Clinical Data Management (CDM), at Gilead you will ... You will be a hands-on 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 Senior Manager, CDM or higher. The Manager, CDM will be responsible for leading and overseeing all aspects of clinical data management for Kite’s clinical development programs with guidance from the Senior Manager, CDM or Associate Director, CDM. The Manager, CDM will be the lead representative working with cross-functional teams such as Clinical Operations, Safety, Biometrics, Clinical Development, and Regulatory as necessary. This position will be responsible for managing other data management roles, overseeing CDM vendors (external and/or CRO), creating and maintaining project timelines and data management documents, working with Clinical Programming to create clinical databases and data quality reports, leading clinical data collection and data review activities, and study closure.

Requirements

• MS/MA in life sciences or related discipline and 4+ years of experience in Data Management OR BS/BA in life science or related discipline and 6+ years of experience in Data Management

Nice To Haves

• Experience as independent lead in managing clinical data management deliverables for regulatory filings
• At least 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 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
• 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 the 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.

Responsibilities

• Lead the management of CDM deliverables in coordination with internal and external cross-functional teams
• Lead by providing CDM expertise for data coordination, collection, and cleaning to efficiently ensure high quality data
• Perform the execution of end-to-end Data Management activities (e.g., eCRF development, Data Review, study lock) for multiple studies across therapeutic areas and/or indications
• Develop and manage data management timelines to ensure study goals and activities are met
• Oversee External Data Management activities by providing project level support of External Data Management tasks (development of Data Transfer Plans, coordination of file transfers to meet study deliverables etc.)
• Anticipate obstacles and difficulties of stakeholders and staff and acts upon them or escalates accordingly in order to meet team goals
• Manage the development and finalization of CDM documents to be filed in the eTMF
• Review and manage the eTMF for completeness and accuracy, ensuring inspection readiness
• Serve as a primary point of contact for internal and external study team members in relation to all Data Management activities
• Ensure completeness, accuracy, and consistency of clinical data and data structure across all projects on an ongoing basis
• Responsible for data review, query management, and metric report delivery to study teams
• Coordinate study timelines and database snapshots for analysis and safety review meetings
• Participate in and/or represent CDM during internal audits as well as Health Authority audits and inspections
• Participate in the development, review, and implementation of processes, policies, SOPs, and associated documents affecting CDM
• Participate in CDM and cross-functional initiatives
• Proactively provides input to continuous improvement activities within Clinical Data Management and provides the relevant support for implementation
• Flexible to changing priorities, detail-oriented, works well under pressure, and able to take on unfamiliar tasks
• Demonstrates an ability to prioritize and delegate effectively
• Demonstrates ability to assume expanded scope of responsibility with respect to volume and complexity of clinical project work
• Works collaboratively with Clinical and Statistical Programming, Clinical Operations, Biostatistics, and others study team members to meet project deliverables and timelines
• Demonstrates proficiency with 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
• Demonstrates excellent verbal and written communication skills, including the ability to clearly describe critical technical CDM aspects to non-CDM staff
• Training and mentoring of junior CDM staff
• Communication and escalation of project level issues including processes, timelines, resourcing, performance, etc.
• May have direct report responsibilities including oversight and development

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees