Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted
virtually and some roles will be asked to temporarily work from home. Over the coming weeks and
months, we will be implementing a phased approach to bringing employees back to site to ensure
the health and safety of our teams.
Please log onto your Internal Career Site to apply for this job.Job Description
Clinical data managers work collaboratively with internal and external colleagues and vendors to support Gilead’s business objectives by ensuring the accurate and timely acquisition of diverse clinical data through efficient CRF/eCRF design, edit specifications, and query resolution processes.
- Capable of handling studies that are complex in scope and volume.
- Effectively interacts with vendors to communicate expectations for study timelines and milestones.
- May lead the design and implementation of the clinical data management process with lvendors including data entry, data quality checking, data transfer, reporting, backup, and recovery.
- Demonstrates ability to appropriately delegate tasks to CDMA I and CDMA II staff members.
- Provide technical and business process input/expertise on new and emerging technologies/vendors for clinical trial execution.
- Demonstrates strong facilitation/presentation skills.
- Demonstrates the ability to lead multiple studies with minimal supervision
- Works collaboratively with Programming (Clinical and Statistical), Clinical Operations, Biostatistics and others such as Clinical Research, Global Patient Safety, Regulatory and Project Management staffs to meet project deliverables and timelines for non- routine clinical data acquisition, quality checking and reporting.
- Ensures completeness, accuracy and consistency of clinical data and data structure.
- Ensures adherence to standard business processes within CDM systems to ensure compliance to regulatory bodies.
- May lead in the design and implementation of clinical data management process with vendors including data entry, data quality checking, data transfer and reporting.
- Leads the preparation and design of CRF/eCRF’s.
- Reviews study protocols and assist in the planning and implementation of the data management portions of clinical studies.
- Interact with site coordinators, investigators, and field clinical staff in collecting data and resolving queries to meet the protocol requirements in a timely manner.
- Utilizes reports to track study progress and ensure timeliness and quality expectations are met.
- Excellent verbal and written communication skills and interpersonal skills are required.
- The ability to problem solve. Exceptional people/project leadership skills are required.
- General knowledge of FDA/EMA regulations and with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA is also required.
Education and Experience:
- 5 years of experience and a BS degree.
- 3 years of experience and a MS degree.
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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 [email protected] for assistance.
For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster.
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For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.