Clinical Records Assoc III
Clinical Records Assoc III
United States Remote
Gilead 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. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats 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 #CreatingPossible
Job Description - Clinical Records Associate III
Specific Education & Experience Requirements:
- 6+ years of experience in the pharmaceutical industry and a BS or BA in a relevant scientific discipline
- 8+ years or experience in the pharmaceutical industry and an AS or AA
- Experience with Veeva Vault eTMF is required
- Understanding of the dynamics between Sponsor and CRO
- Experience as a Clinical Trial Associate or Clinical Research Associate
The 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 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 firstname.lastname@example.org for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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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.
To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States--Remote/Clinical-Records-Assoc-III_R0021619-1
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