Clinical Data Management Manager

About the role

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. 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.

You will act as CDM lead and provide oversight for the execution of CDM activities at the project level, e.g., for a product or multiple complex studies within an indication. You will lead the preparation of CRF/eCRF design, review study protocols, and lead the planning and implementation of CDM portions of clinical studies. You will oversee vendors to ensure high-quality processes for data review, data transfers, and reporting, and use reports to track study progress to meet timelines and quality expectations. You will provide guidance and training to contract research organizations (CROs), vendors, investigators, and study coordinators on CDM requirements, support regulatory submissions, and assist with CDM-related questions in response to audits and inspections. You may also lead special projects that benefit multiple CDM teams or team members.

Responsibilities

• Serves as lead for one or more studies or projects of increasing complexity, including participating in or leading cross-functional working groups.
• Reviews study protocols and assists site coordinators, investigators, and field clinical staff in collecting routine data to meet protocol requirements in a timely manner.
• Identifies, tracks, and resolves CDM queries and issues.
• Acts as a point of contact for study management teams and for Clinical Development regarding data management issues.
• Works collaboratively with other colleagues to meet project deliverables and timelines for clinical data acquisition, quality checking, and reporting.
• Ensures completeness, accuracy, and consistency of routine clinical data and data structure.
• Ensures adherence to standard business processes within CDM systems to assure compliance with regulatory requirements.
• Leads the design and implementation of the CDM process with vendors, including data entry, data quality checking, data transfer, reporting, backup, and recovery.
• Educates study teams and vendors on CDM processes and deliverables, including deviations from established processes.
• Leads the preparation of CRF/eCRF design. Utilizes reports to track study progress and ensures timeliness and quality expectations are met.
• Addresses needs or issues with regulatory submissions and assists with responses to regulatory/compliance audits and inspections.
• Provides technical and business process expertise on new and emerging technologies/vendors for clinical trial execution.
• Leads or otherwise participates in the development, review, and implementation of continuous improvements, processes, policies, SOPs, and other guidance/process documents for CDM.
• Leads or otherwise participates in initiatives to gather, organize, and analyze interim clinical data from various data sources.
• Designs and uses all available vehicles for effective scientific communication within and outside Gilead.
• Trains and mentors less experienced colleagues in CDM processes, projects, programs, and tools.
• Ensures assigned work complies with established practices, policies, and processes and any regulatory or other requirements.

Requirements

• Bachelor's Degree and six years' experience OR Master's Degree and four years' experience.

Preferred Qualifications

• Relevant CDM or other data analytics/data management experience.
• Multiple years’ CDM or other data analytics/data management experience, including experience leading small projects and project teams.
• Demonstrated proficiency in leading CDM or related deliverables, including understanding of project timelines and metrics to ensure databases are delivered as needed and in accordance with established timelines.
• Demonstrated understanding of how CDM impacts product development goals, including understanding of the implications of data collection and handling decisions with cross-functional stakeholders.
• Advanced knowledge of FDA/EMA regulations, NDA and other regulatory requirements, and web-based EDC and CDM systems, as evidenced by increasing independence in managing CDM or related responsibilities.
• Strong project and risk management skills, including demonstrated ability to work within budget constraints while using resources efficiently and in a fiscally responsible manner.
• Knowledge of CDM or general data analytics and data management best practices and tools, and ability to apply this to improve decision-making effectiveness and efficiencies.
• Demonstrated ability and effectiveness identifying, communicating, and escalating project-level issues, such as processes, timelines, resourcing, performance, etc.
• Strong facilitation/presentation skills and ability to appropriately delegate tasks to others.
• Able to coach less experienced colleagues in solving problems.
• Demonstrated ability to be a fast learner.
• Demonstrated ability to be flexible and adaptable to change, to move between projects easily, and provide support/expertise where needed.
• Strong communication and organizational skills.
• Ability to travel when needed.

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 - Understanding the skills, experience, aspirations, and potential of their employees and coaching them on current performance and future potential. Ensuring employees receive the feedback and insight needed to grow, develop, and realize their purpose.
• Empower Teams - Connecting the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. Providing the support needed to remove barriers and connect their team to the broader ecosystem.

Pay

The salary range for this position is $136,340.00 - $176,440.00. 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

• Company-sponsored medical, dental, vision, and life insurance plans.

Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.