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Clinical Trials Management Associate, Clinical Operations - Oncology, Virology, Inflammation & Early Development

Company: Gilead Sciences, Inc.
Location: San Mateo
Posted on: May 3, 2021

Job Description:

Clinical Trials Management Associate, Clinical Operations - Oncology, Virology, Inflammation & Early DevelopmentUnited States - California - Foster CityUnited States - Washington - SeattleGilead 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 scaleInclusion 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 #CreatingPossibleJob DescriptionCLINICAL 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 terminologyMaintains internal Clinical Operations databases and document repositoriesUnder 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 CROsUnder supervision may serve as the key operational contact and coordinate with vendors like central lab, IVRS for study implementationMay assist to set up, organize and maintain clinical study documentation (e.g. Trial Master Files) including preparation for internal/external audits, final reconciliation and archivalUnder 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 requiredMay resolve routine monitoring issuesProactively identifies potential operational challenges and in collaboration with senior team members provides solutions to ensure study execution remains on trackAssists in preparation of safety, interim and final study reports, including resolving data discrepanciesMay assist with Investigator Meeting coordination, activities preparation and where required review meeting minutesMust be able to participate in departmental or interdepartmental strategic initiatives under general supervisionMay contribute to SOP developmentTravel may be requiredKnowledge:Excellent verbal, written, interpersonal and presentation skills are requiredKnowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studiesWorking knowledge and experience with Word, PowerPoint and ExcelExperience and Skills:At least 2+ year of relevant experience and a BS or BA in a relevant scientific discipline orAt 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 for assistance.For more information about equal employment opportunity protections, please view the EEO is the Law' poster.NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACTYOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTPAY TRANSPARENCY NONDISCRIMINATION PROVISIONOur 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.For Current Gilead Employees and Contractors:Please log onto your Internal Career Site to apply for this job.To apply, visit 2017 Inc. All rights reserved.Posted by the FREE value-added recruitment advertising agency jeid-7ef91b0c074b9b42829b514e1bf815f3

Keywords: Gilead Sciences, Inc., San Mateo , Clinical Trials Management Associate, Clinical Operations - Oncology, Virology, Inflammation & Early Development, Other , San Mateo, California

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