Job Description

At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.

Job Description

Manager, Clinical Data Management (CDM) will be a hands-on role working cross functionally with the Biostatistics, Programming, and Clinical Operations teams in supporting our efforts in this exciting area of Cancer \Immunotherapy. The role will report into the Senior Manager, CDM or higher and will lead and manage the Data Manager role.

The Manager, CDM will be responsible for leading and overseeing all aspects of clinical data management for Kite’s clinical development programs with guidance from the Senior Manager, CDM or Associate Director, CDM. This position could be responsible for managing data manager roles, CDM vendors (external and/or CRO), project timelines, working with Programming to create data quality reports, clinical data collection, data review and study closure. The Manager, CDM will be the lead representative working with cross-functional teams such as Clinical Operations, Safety and Regulatory as necessary.

Responsibilities (include but are not limited to):

• Lead the management of CDM deliverables in coordination with internal and external cross functional teams
• Lead by providing CDM expertise for data coordination, collection, and cleaning to efficiently ensure high quality data
• Perform the execution of Data Management activities (e.g., eCRF development, Data Review, study lock) for multiple studies across therapeutic areas and/or indications.
• Develop and manage data management timelines to ensure study goals and activities are met
• Initiates and leads project level coordination and day to day oversight of External Data Management tasks (development of Data Transfer Plans, coordination of file transfers to meet study deliverables etc.)
• Anticipates obstacles and difficulties of stakeholders and staff and acts upon them or escalates accordingly in order to meet team goals
• Manage the development and finalization of CDM documents to be placed in the eTMF with guidance from Sr. Manager CDM if necessary
• Reviews and manages the eTMF for completeness and accuracy, ensuring inspection readiness
• Serves as a primary point of contact for internal and external study team members
• Ensures completeness, accuracy and consistency of clinical data and data structure across all projects on an ongoing basis.
• Review, query management, report delivery to study teams, study timeline and database snapshot coordination for analysis including Safety Review Team
• Performs management of CDM deliverables as described or could possibly provide oversight and guidance to Data Manager leading CDM deliverables
• Possibly direct report responsibility including oversight and development
• Responsible to lead end-to-end clinical data management activities
• Participate and/or represent CDM during internal audits as well as Health Authority audits and inspections
• Participate in the development, review and implementation of processes, policies, SOPs and associated documents affecting CDM.
• Participate in CDM and cross-functional initiatives
• Proactively provides input to continuous improvement activities within Clinical Data Management and provides the relevant support.
• Flexible to changing priorities, detail-oriented, works well under pressure and able to take on unfamiliar tasks
• Demonstrates an ability to prioritize and delegate effectively.
• Demonstrates ability to assume expanded scope of responsibility with respect to volume and complexity of clinical project work.
• Works collaboratively with Programming (Clinical and Statistical) Clinical Operations, Biostatistics and others study team members to meet project deliverables and timelines.
• Ability to manage moderately complex clinical data acquisition, quality checking and reporting.
• Training and mentoring of junior CDM staff on business process and clinical programs.
• Communication and escalation of project level issues including processes, timelines, resourcing, performance, etc.
• May have direct report responsibilities including oversight and development

Basic Qualifications

• MS/MA in life sciences or related discipline and 4+ years of experience in Data Management OR
• BS/BA in life science or related discipline and 6+ years of experience in Data Management OR
• High School degree and 10+ years of experience in Data Management

Preferred Qualifications

• Demonstrated knowledge of FDA, EMA, ICH guidelines and regulations covering clinical trials, statistics, and data management
• Experience lead in managing clinical data management deliverables for regulatory filings independently or with oversight support
• Excellent verbal and written communication skills, including the ability to clearly describe critical technical CDM aspects to non-CDM staff

The salary range for this position is: $117,725.00 - $152,350.00. 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.

For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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 careers@gilead.com for assistance.

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