Job Description

Job Description

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

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 Gilead and help create possible, together.

Manager, Clinical Data Management (CDM) 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 global clinical development programs with guidance from the Senior Manager, CDM or above.

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 overseeing other data management roles and CDM vendors (external and/or CRO), creating and maintaining project timelines and data management documents, working with EDC Programming and Clinical Programming to create clinical databases and data quality reports, leading clinical data collection and data review activities, and study closure.
It is essential to be able to speak fluent Japanese and English for this role.

Responsibilities (include but are not limited to):

• 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 global/regional 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, Clinical Development, 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 English 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.

Basic Qualifications

• 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 OR
• High School degree and 10+ years of experience in Data Management
• Must be fluent in Japanese and English language

Preferred Qualifications

• 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 and data review tools (e.g., Medidata Rave, Veeva EDC, Medrio EDC, Oracle, TrialGrid, JReview, etc.) and well versed in industry trends and emerging technologies supporting data collection

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.

Job Tags

Similar Jobs