Clinical Trials Manager

Job Description

Gilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercialises innovative medicines in areas of unmet medical need. With each new drug discovery and investigational candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include liver viral illnesses, inflammatory diseases, and cancer.

Position Overview

CTM is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Clinical Operations plays a key role in ensuring all Gilead clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of Gilead’s products.

Job Responsibilities

• Provide guidance and daily oversight for the successful management of all aspects of Phase I to IV within designated program budgets and timelines

• Typically serves as the key operational contact for Gilead studies, providing oversight for the site evaluation, initiation, and close-out visits in addition to routine monitoring visits, either directly or through CROs

• Participates in and manages project meetings and conference calls with CROs, other vendors and cross-functional teams

• Provide guidance and training to CROs, vendors, investigators and study coordinators on study requirements

• Resolve issues using national and international regulations, guidelines, and investigator interaction

• Leads or otherwise assists in the preparation of safety, interim and final study reports, including resolving any data discrepancies.

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

• Participates in multiple departmental or interdepartmental strategic initiatives under limited supervision

• Domestic and/or International travel is required

Essential Duties

• To serve as the local Clinical Operations representative and point of contact for key stakeholders of the responsible project

• To collaborate with study team across the world and CRO to meet the cross functional study timelines and troubleshoot country/site specific operations issues

• To conduct or support site/country feasibility assessment and site selection

• To develop and make a good relationship with investigators and site staffs

• To leverage local knowledge and relationships and to work collaboratively with Gilead affiliate personnel (Medical Affairs, Regulatory, Patient Safety) to ensure optimal support for Gilead’s clinical development programs and to ensure relevant information from sites is triaged and communicated to the study teams and TA Leads as necessary

• To leverage local knowledge and relationships to ensure optimal support for Gilead’s clinical development programs and relevant information from sites is triaged and communicated to the study teams and TA Leads as necessary

Requirements

• At least 5+ years of experience in clinical trials (oncology preferred) and a BS/ BA/ RN in a relevant scientific discipline

• Excellent interpersonal skills and demonstrated ability to lead is required

• Working knowledge and experience with Word, PowerPoint and Excel