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Gilead Sciences, Inc. Clinical Trials Manager 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.

We are seeking a talented, experienced, and highly motivated candidate to join the Clinical Operations team.

Clinical Trials Manager, Clinical Operations (CTM)

Specific Responsibilities and Skills for Position:

  • Drafts or reviews relevant documents including protocols, informed consents, case report forms, monitoring plans, other study plans, and clinical study reports

  • Must be able to understand, interpret and explain protocol requirements to others

  • Creates or maintains study timelines, including timelines for datasweep and CSR activities

  • 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 a functional area

  • Facilitate meetings, such as the cross-functional Study Management Team meetings or internal Clinical Operations team meetings

  • Contributes to development of RFPs and participates in selection of CROs/vendors

  • May be asked to train CROs, vendors, investigators and study coordinators on study requirements

  • Manage vendors, such as CRO, IXRS, and central laboratory vendors

  • Contributes to development of study budget

  • May serve as a resource for others within the company for clinical trials management expertise

  • Able to examine functional issues from an organizational perspective and work collaboratively with cross-functional team members

  • Participates in the recruiting and hiring process for CPA/CTMA/Sr. CTMA and support their professional development

  • May 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 required

Knowledge:

  • 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 Excel. Experience with Microsoft Project preferred.

  • Experience with regional or vendor management

Experience and Skills:

  • At least 5+ years of experience and a RN (2 or 3 year certificate) or BS/BA in a relevant scientific discipline

  • At least 3+ years of experience and a Masters' degree or higher; scientific discipline 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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