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Gilead Sciences, Inc. Clinical Trials Management Associate (CTMA) in Morris Plains, New Jersey

Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

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 Management Associate, Clinical Operations - Oncology (CTMA)

We are seeking a talented, experienced, and highly motivated candidate to join the Oncology Clinical Operations team. This position will be located in either Foster City, Seattle, WA or Morris Plains, NJ

Specific Responsibilities and Skills for Position:

  • Must be familiar with routine medical/scientific terminology

  • Maintains internal Clinical Operations databases and document repositories

  • Under supervision may serve as the key operational contact for Gilead (GS) studies, providing assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs

  • Under supervision may serve as the key operational contact and coordinate with vendors like central lab, IVRS for study implementation

  • May assist to set up, organize and maintain clinical study documentation (e.g. Trial Master Files) including preparation for internal/external audits, final reconciliation and archival

  • Under supervision may assist in preparation and development of protocols, informed consents, monitoring plans and other study related plans.

  • Under supervision may assist in review of case report forms, abstracts, presentations, manuscripts and clinical study reports.

  • May monitor or co-monitor study sites, performing routine data collection, source data verification, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs and Monitoring Plan, as required

  • May resolve routine monitoring issues

  • Proactively identifies potential operational challenges and in collaboration with senior team members provides solutions to ensure study execution remains on track

  • Assists in preparation of safety, interim and final study reports, including resolving data discrepancies

  • May assist with Investigator Meeting coordination, activities preparation and where required review meeting minutes

  • Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision

  • May contribute to SOP development

  • Travel may be required

Knowledge:

  • Excellent verbal, written, interpersonal and presentation skills are required

  • 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 Excel

Experience and Skills:

  • At least 2+ year of relevant experience and a BS or BA in a relevant scientific discipline or

  • At least 2+ year of experience and an RN (2 or 3 year certificate)

  • Prior oncology clinical trials experience is preferred

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.​

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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 (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

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 be fully vaccinated against COVID-19 as a condition of employment. The health of our employees, contractors, their loved ones, our partners and the communities and people we serve is a top priority. Vaccination is the most effective way currently available to deliver on that priority.

The purpose of the vaccination requirement is to minimize the spread of COVID-19 in the workplace and support the health and safety of our communities. A person is considered fully vaccinated two weeks after the second dose of a two-dose vaccine or two weeks after 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 an accommodation.

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