Sr. Clinical Trials Manager, Clinical Operations (Oncology)

For Current Gilead Employees and Contractors:

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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
 

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.

**This position can be based at either Parsipanny, NJ or Foster City, CA. This is NOT a remote position***

RESPONSIBILITIES: 

• In partnership with Clinical Program Manager or Associate Director, provides guidance and daily oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines

• Communicates with functional peers regarding project status and issues and ensure project team goals are met

• Oversees operational aspects of assigned clinical trial(s) and oversees clinical trial conduct including study start-up, enrollment, maintenance and close-out.

• Prepares and/or contributes to development of study-related documents (e.g., Clinical protocols, Informed consent forms, Pharmacy Manual, Monitoring Plan, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans, Clinical Study Report

• Coordinates data review to support interim/final data analysis 

• Participates in study strategy development.

• Maintains study timelines.

• Contributes to development of study budget.

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

• Provide guidance and training to CROs, vendors such as IWRS, Central lab, eCOA, recruitment vendors,investigators and study coordinators on study requirements

• Manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management). 

• Proactively identifies potential study issues/risks and recommends/implements solutions.

• Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings.

• May participates in the recruiting and hiring process for CTMs and supports their professional development

• May mentor other junior team members

• Coaches members of a work team and ensures adherence to established guidelines

KNOWLEDGE: