Clinical Data Management Manager in Uxbridge

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.

As a Manager, Clinical Data Management (CDM), at Gilead 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.

Key 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.
• Anticipate obstacles and difficulties of stakeholders and staff and act upon them or escalate accordingly.
• 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.
• Proactively provide input to continuous improvement activities within Clinical Data Management.
• Demonstrate an ability to prioritize and delegate effectively.
• Work collaboratively with Clinical and Statistical Programming, Clinical Operations, Biostatistics, and other study team members to meet project deliverables and timelines.
• Demonstrate proficiency with web‑based Electronic Data Capture (such as Medidata Rave and other clinical data management systems).
• 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.

Preferred Qualifications:

• Experience as independent lead in managing clinical data management deliverables for regulatory filings.
• Relevant industry experience with clinical trials and a successful track record of leading through influence.
• Strong knowledge of industry‑leading EDC tools 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.
• Empower Teams – connect the team to the organization by aligning goals, purpose, and organizational objectives.

Equal Employment Opportunity (EEO): It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates to recruit, select and employ the most qualified persons available for positions throughout the Company.