Clinical Records Manager, Clinical Operations

Company: Gilead Sciences, Inc.
Location: San Mateo
Posted on: January 20, 2023

Job Description:

Clinical Records Manager, Clinical OperationsUnited States - RemoteUnited States - New Jersey - Morris PlainsUnited 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 For Current Gilead Employees and Contractors:Please log onto your Internal Career Site to apply for this job.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 DescriptionThe Clinical Records Manager position is the subject matter expert to ensure a complete and accurate Trial Master File (TMF) though documentation quality and consistency across clinical trials and programs. This position will provide TMF quality support to the study teams, functional areas, and third-party vendors. Specific Education & Experience Requirements:

• 8+ years of experience in the pharmaceutical industry and a BS or BA in a relevant scientific discipline
• 10+ years or experience in the pharmaceutical industry and an AS or AA
• Experience with electronic TMF systems
• Understanding of the dynamics between Sponsor and CRO
• Experience as a Clinical Trial Associate or Clinical Research AssociateThe successful candidate will partner with cross functional teams as well as Clinical Research Organization (CRO) and Functional Service Provider (FSP) to ensure timely and quality delivery of the TMF. Specific Job Responsibilities:
• Participate in the review and approval of TMF Management Plans with the study teams.
• Manage the quality control of documents submitted to the TMF.
• Participate in study team meetings and provide or present regular TMF metric updates.
• Maintain awareness of study events and associated documentation requirements through collaboration with study team.
• Support study teams in understanding TMF-related responsibilities, requirements, and expectations.
• Initiate and manage interim functional quality checks and clinical research organization TMF oversight activities.
• Act as point of contact for study team TMF questions and manages close-out of TMF related issues.
• Support study team in TMF retrieval during internal audits and external inspections.
• Oversee future document migrations.
• Maintain thorough and current knowledge and understanding of GCP, ICH and GLP regulations associated with the maintenance and retention of clinical trial documentation.
• Ability to participate in and/or lead departmental or interdepartmental strategic initiatives.
• Excellent verbal, written, interpersonal and presentation skills are required.Some travel may be required.For Colorado Job Applicants: The salary range for this position is:$119,040.00 - $178,560.00Gilead considers a range of factors, including background and experience, when determining base compensation. These considerations means actual compensation will vary. Position is also eligible for bonus and benefits. For more information, visit 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.Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S., Canada, Australia, Singapore, and Hong Kong employees and contractors to receive the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation. 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 PAY TRANSPARENCY NONDISCRIMINATION PROVISION 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.For Current Gilead Employees and Contractors:Please log onto your Internal Career Site to apply for this job.
  
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Keywords: Gilead Sciences, Inc., San Mateo , Clinical Records Manager, Clinical Operations, Executive , San Mateo, California