Clinical Trials Manager
Company: Gilead Sciences, Inc.
Location: San Mateo
Posted on: May 14, 2022
Job 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 Manager (CTM), Clinical Operations - Late
PhaseSpecific Responsibilities and Skills for Position:The CTM-Late
Phase plays a vital role in the successful implementation of
important Gilead Sponsored Non-Interventional Studies.For Gilead
Sponsored Non-Interventional Studies (e.g., Post Authorisation
Safety Studies, Patient Registries, HCP Survey, Patient Survey,
Real World Evidence, Prospective and Retrospective data collection
studies):
- Drafts and coordinates review of relevant documents including
protocols, informed consents, case report forms, monitoring plans,
investigator brochures and clinical study reports
- Must be able to understand, interpret and explain protocol
requirements to others
- Maintains study timelines
- Coordinates review of data listings and preparation of
interim/final clinical study reports
- Assists in determining the activities to support a project's
priorities within functional area
- Contributes to development of RFPs and participates in
selection and management of CROs/vendors, investigator/site
selection, ongoing coordination of study sites, either directly or
via CROs
- May be asked to train CROs, vendors, investigators and study
coordinators on study requirements
- Contributes to development of study budget
- Collaborate with colleagues in Clinical Operations, Medical
Affairs, Clinical Research, Pharmacovigilance, Real World Evidence,
Project/Portfolio Management, Regulatory, Data Science, Quality
Compliance and within the U.S. and EU as required ensuring delivery
of assigned studies
- May serve as a resource for others within the company for
clinical trials management expertise
- Able to examine functional issues from an organizational
perspective
- Participates in the recruiting and hiring process for
CPA/CTMA/Sr. CTMA and support their professional development
- May contribute to development of abstracts, presentations and
manuscripts
- Under supervision, may design scientific communications within
the company
- Must be able to participate in multiple departmental or
interdepartmental strategic initiatives under limited
supervision
- Must have a general, functional expertise to support SOP
development and implementation
- Travel may be requiredAdditionally may manage and support the
following:
- Investigator Sponsored Research/Collaborative Research studies
including Fair Market Value and feasibility assessment, contract
milestone advice, tracking and publication follow-up as
required
- Compassionate Use programsKnowledge:
- Excellent teamwork, communication, decision-making and
organizational skills are required
- Thorough 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
ExcelExperience and Skills:
- At least 5+ years of experience and a BS or BA degree in a
relevant scientific discipline
- At least 3+ years of experience and a Masters' degree or
higher; scientific discipline preferredExperience working at a
Sponsor or CRO on interventional and/or non-interventional studies
requiredFor 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. 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 'EEO is the Law' 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 Trials Manager, Executive , San Mateo, California
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