Clinical Data Management Manager

Key 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 assist 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 in colleagues in CDM processes, projects, programs and tools.
• Ensures assigned work complies with established practices, policies and processes and any regulatory or other requirements

Basic Qualifications:

• Bachelor's Degree and Six Years' Experience
• OR
• Masters' Degree and Four Years' Experience

Preferred qualifications:

• Relevant CDM or other data analytics / data management experience is preferred
• 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.
• 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.
• 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.
• When needed, ability to travel.
• 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 - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem
• 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 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.
• Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact [email protected] for assistance.
• For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
• NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
• YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
• Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
• Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
• Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
• Please apply via the Internal Career Opportunities portal in Workday.

For jobs in the United States:

For Current Gilead Employees and Contractors: