Clinical Trials Manager
3 개월전에
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.
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
Gilead Core Values
Integrity (always doing the right thing)
Teamwork (collaborating in good faith)
Excellence (working at a high level of commitment and capability)
Accountability (taking personal responsibility)
Inclusion (encouraging diversity)
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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