Sr. Clinical Trials Management Associate

Location
Foster City, CA
Posted
Nov 26, 2021
Ref
2667493
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Sr. Clinical Trials Management Associate
United States - California - Foster City

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. 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 scale
Inclusion 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 #CreatingPossible


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.

Senior Clinical Trials Management Associate, Clinical Operations (Sr. CTMA)

Specific Job Responsibilities:
  • Monitors clinical trial sites.
  • Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, and monitoring plans.
  • Contributes to development of RFPs and participate in selection of CROs/vendors.
  • Manage CROs/vendors.
  • Coordinates review of data listings and preparation of interim/final clinical study reports.
  • May contribute to development of abstracts, presentations, and manuscripts,
  • Ensures effectiveness of site budget/contract process.
  • May be asked to train CROs, vendors, investigators, and study coordinators on study requirements.
  • Assists in determining the activities to support a project's priorities within functional area.
  • Some travel may be required.
  • Excellent teamwork, communication, decision-making and organizational skills are required.
  • Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
  • Must be able to generally understand, interpret, and explain protocol requirements to others.
  • Must be able to prioritize multiple tasks.
  • May serve as a resource for others within the company for clinical trials management expertise.
  • Under general supervision, is able to examine functional issues from an organizational perspective.
  • 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.


Specific Education & Experience Requirements:
  • 3+ years of experience and a BS or BA in a relevant scientific discipline.

OR
  • 3+ years 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 careers@gilead.com 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.

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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:

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