Sr Clinical Data Management Manager

Gilead Sciences•Foster City, CA

19h

About The Position

Clinical Data Management (CDM) supports drug discovery, development and marketed products across Gilead by ensuring the accurate and timely acquisition, analysis and reporting of diverse clinical data through CRF / eCRF design, editing specifications and query resolution processes. CDM also manages data transfers from vendors, such as central labs and others including eCOA providers and other external technology partners. You will serve as a Sr. Clinical Data Management Manager with primary responsibility for the oversight and operational management of patient-centric data collection technologies, including eCOA and related digital solutions across the clinical development portfolio. In this role, you will provide leadership and oversight for eCOA vendors, ensuring the successful implementation, quality, compliance, and delivery of patient-reported and other patient-centric clinical trial data. You will partner closely with Clinical Operations, Biostatistics, Statistical Programming, Technology teams, CROs, and external vendors to support technology implementation and study execution activities, including requirements review, system and study design discussions, user acceptance testing (UAT), issue management, risk identification and mitigation, vendor governance, and operational oversight. You will monitor vendor performance through key metrics and quality indicators, manage escalations, identify process improvement opportunities, and help drive consistency, efficiency, and inspection readiness across studies. In addition, you will contribute to the evaluation and adoption of innovative technologies, analytics, automation, and digital capabilities that improve operational efficiency, vendor oversight, study execution, and data quality. You may also lead cross-functional initiatives focused on process optimization, standards development, and continuous improvement of patient-centric data collection solutions and associated business processes.

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.
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.

Nice To Haves

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.

Responsibilities

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.