Manager, Clinical Data Management
United States - California - Foster City
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossibleFor Current Gilead Employees and Contractors:
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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 lead and manage a small team of direct reports. You may act as CDM lead for one or more projects; providing oversight for the execution of CDM activities at the project level for a product or multiple complex studies within an indication. You may represent CDM on cross-functional teams. You will provide guidance and training to contract research organizations (CROs), vendors, investigators and study coordinators on CDM requirements. You will also support regulatory submissions of assigned projects and assist with CDM-related questions in response to audits and inspections. You may participate in the development, review and implementation of CDM policies, SOPs, processes, documentation and other tools. You may also lead special projects that benefit multiple CDM teams / team members.EXAMPLE RESPONSIBILITIES:
- Manages a small CDM team, including responsibilities to hire, develop and retain diverse top talent in the team. Sets clear and elevating goals for the team and individual direct reports. Coaches direct reports on their performance, development and career interests.
- May serve 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.
- May lead or otherwise oversees 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.
- May lead or otherwise oversees 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 in colleagues in CDM processes, projects, programs and tools.
- Adheres to regulatory requirements, industry standards and Gilead SOPs and ensures the same across own team.
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.Minimum Education & Experience
Knowledge & Other Requirements
- PhD in life sciences or related discipline. PhD with 2+ years' relevant CDM or other data analytics / data management experience is preferred.
- MA / MS in life sciences or related discipline with 4+ years' relevant CDM or other data analytics / data management experience.
- BA / BS in life sciences or related discipline with 6+ years' 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 abilities to effectively lead and manage a team of direct reports, either through past effective matrix or direct line management and/or effectiveness coaching and mentoring less experienced colleagues.
- 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.
- Demonstrates 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.
- Has strong project and risk management skills, including demonstrated ability to work within budget constraints while using resources efficiently and in a fiscally responsible manner.
- Has knowledge of CDM or general data analytics and data management best practices and tools and has shown 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.
- Demonstrates strong facilitation / presentation skills and ability to appropriately delegate tasks to others.
- 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.
- When needed, ability to travel.
The salary range for this position is: $129,540.00 - $167,640.00. 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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