Associate Director, Clinical Records & Information Management - REMOTE

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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.
 

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Job Description
 

The Associate Director, Clinical Records & Information Management reports to Global Head, Clinical Records and Information Management, partnering with cross functional teams as well as Clinical Research Organizations (CRO) and Functional Service Providers (FSP) to ensure TMF compliance with industry standards and regulations with the goal of Inspection Ready for clinical studies.

This role is a member of the Clinical Records leadership team accountable for end to end delivery of TMF integrations/migrations for acquired assets, asset divestiture and partnerships and Inspection Readiness across the clinical portfolio.

The ideal candidate will have a proven track record of innovation and creative solutions to deliver on business expectations, improve overall TMF Compliance and Inspection Readiness capabilities.

PRIMARY RESPONSIBILITIES:

• Lead end to end TMF migrations and integrations in support of asset acquisitions, divestitures and partnerships
• Oversee standards and process to partner with study teams to conduct quality checks of the TMF for inspection readiness and audit/inspection preparation, with regulations, ICH guidelines, and internal procedural requirements
• Oversee standardized TMF practices across clinical trial teams to ensure consistency and adherence to best practices
• Responsible for overseeing the activities of clinical teams and external vendors ensuring study documents are managed with adherence to ICH-GCP guidelines, other regulatory requirements, and internal and external standard operating procedures (SOPs) and that their assigned studies are inspection-ready
• Partner with Quality Assurance/Compliance teams in support of risk mitigation strategies, corrective and preventative actions, and issue resolution, along with proactively communicating changes, updates, and issues to TMF stakeholders
• Collaborate with key internal and external stakeholders to assess process alignment and prioritize procedural and TMF system changes to ensure continued improvements and compliance
• Participate in internal process improvement projects/initiatives to continuously improve operational excellence in support of inspection readiness
• Review data quality outputs and audit outputs to identify trends; develop process improvements, includes reviewing and reporting metrics established for performance TMF reviews and providing action plans as appropriate
• Proven ability to drive process improvements and manage multiple projects simultaneously
• Ensures reports and dashboards are developed and available for teams in eTMF
• May recruit, hire, mentor, and manage direct reports and support their professional development.
• Strong communication and influe