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Please log onto your Internal Career Site to apply for this job.Job DescriptionJob Description
CLINICAL OPERATIONS: Clinical Operations is responsible for the execution of all Phase 1-4 clinical trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and Development Operations functions, ensures that all clinical trial activities are performed in accordance with all applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of Gilead’s products.
Clinical Trials Management Associate, Clinical Operations (CTMA)
Openings across all Therapeutic Areas- Oncology, Virology, Inflammation & Early Development. Positions can be located in Foster City CA, Seattle WA, or New Jersey office sites.
We are seeking a talented, experienced, and highly motivated candidate to join the Clinical Operations team.
Specific Responsibilities and Skills for Position:
- Must be familiar with routine medical/scientific terminology
- Maintains internal Clinical Operations databases and document repositories
- Under supervision may serve as the key operational contact for Gilead (GS) studies, providing assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs
- Under supervision may serve as the key operational contact and coordinate with vendors like central lab, IVRS for study implementation
- May assist to set up, organize and maintain clinical study documentation (e.g. Trial Master Files) including preparation for internal/external audits, final reconciliation and archival
- Under supervision may assist in preparation and development of protocols, informed consents, monitoring plans and other study related plans.
- Under supervision may assist in review of case report forms, abstracts, presentations, manuscripts and clinical study reports.
- May monitor or co-monitor study sites, performing routine data collection, source data verification, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs and Monitoring Plan, as required
- May resolve routine monitoring issues
- Proactively identifies potential operational challenges and in collaboration with senior team members provides solutions to ensure study execution remains on track
- Assists in preparation of safety, interim and final study reports, including resolving data discrepancies
- May assist with Investigator Meeting coordination, activities preparation and where required review meeting minutes
- Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision
- May contribute to SOP development
- Travel may be required
- Excellent verbal, written, interpersonal and presentation skills are required
- Knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies
- Working knowledge and experience with Word, PowerPoint and Excel
Experience and Skills:
- At least 2+ year of relevant experience and a BS or BA in a relevant scientific discipline or
- At least 2+ year of experience and an RN (2 or 3 year certificate)
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 [email protected] for assistance.
For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster.
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Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.