Clinical Trials Manager

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
 

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
 

• Must meet all requirements for Senior Clinical Research Associate position and have demonstrated proficiency in all relevant areas.

• Coordinating and supervising all aspects of a clinical study. Monitors clinical trial sites.

• Assists Clinical Program Manager in overall study management.

• Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports.

• Maintains study timelines.

• Contributes to development of study budget.

• 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.

• Under supervision, may design scientific communications within the company.

• Travel is 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:

• 6+ years of experience and a BS or BA in a relevant scientific discipline.

• 6+ years of experience and an RN (2 or 3 year certificate).

• Specific Job Responsibilities:

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, 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 [email protected] for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the  legal duty to furnish information; or (d) otherwise protected by law.
 

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.

Please apply via the Internal Career Opportunities portal in Workday.