Clinical Records Manager, Clinical Operations
Company: Gilead Sciences, Inc.
Location: San Mateo
Posted on: January 20, 2023
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
- 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
- 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
Keywords: Gilead Sciences, Inc., San Mateo , Clinical Records Manager, Clinical Operations, Executive , San Mateo, California
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