Sr Clinical Data Management Manager

• Serves as the CDM subject matter expert for eCOA and other patient-centric data collection technologies across one or more studies, programs, or therapeutic areas.
• Provides oversight of eCOA vendors and technology partners to ensure successful implementation, quality, compliance, and delivery of patient-reported and other patient-centric clinical trial data.
• Reviews study protocols and participates in study planning activities to ensure patient-centric data collection requirements are appropriately incorporated into study execution.
• Leads the review of vendor requirements, specifications, and study documentation to ensure alignment with protocol objectives, business requirements, and operational standards.
• Lead the evaluation, adoption, and implementation of innovative technologies, automation capabilities, and digital solutions that enhance Clinical Data Management processes, vendor oversight, and study delivery.
• Provides oversight of user acceptance testing (UAT) activities, including strategy, planning, execution support, issue tracking, and final readiness recommendations.
• Oversees vendor issue management processes, including identification, escalation, tracking, trending, root cause analysis, and resolution of operational issues.
• Monitors vendor performance, quality metrics, timelines, risks, key performance indicators, and service levels to ensure successful delivery of study objectives.
• Collaborates with Clinical Operations, Biostatistics, Statistical Programming, Technology teams, and external partners to support implementation, testing, data review, issue management, and operational excellence.
• Support the design, implementation, and continuous improvement of digital solutions that strengthen Clinical Data Management operations, efficiency, and business objectives.
• Establish and maintain processes, standards, and governance frameworks that support the effective adoption of automation, emerging technologies, and technology-enabled solutions within Clinical Data Management.
• Identifies, assesses, and mitigates operational and vendor-related risks impacting study execution, data quality, timelines, or compliance.
• Utilizes operational reports, dashboards, and metrics to identify trends, monitor vendor performance, and support management decision-making.
• Provides subject matter expertise on eCOA platforms, patient-centric data collection technologies, digital health solutions, analytics, reporting capabilities, and operational technology innovations.
• Leads or participates in initiatives focused on standardization, process optimization, operational excellence, and continuous improvement of vendor oversight and technology implementation processes.
• Evaluates and supports implementation of innovative technologies, emerging digital capabilities, and automation solutions that improve operational efficiency, data quality, and study execution.
• Supports regulatory submissions and contributes to audit and inspection readiness activities related to eCOA vendors, systems, processes, and documentation.
• Ensures compliance with applicable regulations, GCP requirements, SOPs, quality standards, and organizational expectations.
• Develops and delivers training, guidance, and best practices to study teams, CROs, and vendors regarding eCOA processes, technology platforms, and operational expectations.
• Leads or supports development and maintenance of SOPs, work instructions, standards, templates, and governance processes related to eCOA and patient-centric technologies.
• Participates in cross-functional initiatives focused on advancing patient-centric technologies, operational innovation, digital capabilities, analytics solutions, and process optimization opportunities.
• Acts as a key stakeholder in vendor governance activities, business reviews, escalation management, and continuous improvement initiatives.

Requirements

• PhD in Life Sciences or related discipline with 2+ years of relevant Clinical Data Management or related data management experience preferred.
• MS/MA in Life Sciences or related discipline with 4+ years of relevant Clinical Data Management or related data management experience.
• BS/BA in Life Sciences or related discipline with 6+ years of relevant Clinical Data Management or related data management experience.
• Experience leading clinical data management activities for multiple studies or programs.
• Experience managing cross-functional relationships and external vendors within clinical development environments.
• Experience supporting patient-centric data collection technologies, including eCOA, ePRO, eDiary, decentralized trial technologies, digital health technologies, or related platforms.

• Demonstrated understanding of eCOA/ePRO technologies, implementation approaches, vendor oversight, and operational management within clinical trials.
• Strong understanding of vendor governance, quality oversight, risk management, escalation management, and performance monitoring.
• Advanced knowledge of FDA/EMA regulations, GCP, and applicable regulatory requirements.
• Strong project, operational, and risk management skills.
• Knowledge of patient-centric data collection technologies, digital solutions, and clinical trial technology ecosystems.
• Demonstrated ability to identify, communicate, and escalate project and operational risks.
• Experience reviewing requirements documentation, facilitating testing activities, and supporting system implementation efforts.
• Experience using metrics, dashboards, analytics, and operational reports to support oversight and decision-making.
• Experience leveraging technology, analytics, and automation capabilities to improve operational efficiency, data quality, and business processes.
• Experience with data analytics, scripting, programming, or reporting technologies (e.g., Python, SQL, R, Power BI, Tableau, or similar tools) is preferred.
• Experience evaluating and implementing emerging technologies, digital solutions, or process improvement initiatives within a regulated environment is preferred.
• Strong facilitation, presentation, communication, and organizational skills.
• Demonstrated interest in technology innovation, automation, and data-driven process improvement within clinical development environments.
• Ability to influence and collaborate across multiple functional areas and external partners.
• Demonstrated ability to identify and implement process improvements.
• Ability to coach and mentor less experienced colleagues.
• Flexible and adaptable to change.
• Ability to travel when needed.

The salary range for this position is: $157,590.00 - $203,940.00. Gilead 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.

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