Clinical Trials Manager

Gilead Sciences

5d•$133,195 - $172,370

About The Position

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.

Requirements

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

Nice To Haves

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

Responsibilities

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.