Clinical Trials Manager

Company: Gilead Sciences, Inc.
Location: San Mateo
Posted on: May 14, 2022

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.Clinical Trials Manager (CTM), Clinical Operations - Late PhaseSpecific Responsibilities and Skills for Position:The CTM-Late Phase plays a vital role in the successful implementation of important Gilead Sponsored Non-Interventional Studies.For Gilead Sponsored Non-Interventional Studies (e.g., Post Authorisation Safety Studies, Patient Registries, HCP Survey, Patient Survey, Real World Evidence, Prospective and Retrospective data collection studies):

• Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures and clinical study reports
• Must be able to understand, interpret and explain protocol requirements to others
• Maintains study timelines
• Coordinates review of data listings and preparation of interim/final clinical study reports
• Assists in determining the activities to support a project's priorities within functional area
• Contributes to development of RFPs and participates in selection and management of CROs/vendors, investigator/site selection, ongoing coordination of study sites, either directly or via CROs
• May be asked to train CROs, vendors, investigators and study coordinators on study requirements
• Contributes to development of study budget
• Collaborate with colleagues in Clinical Operations, Medical Affairs, Clinical Research, Pharmacovigilance, Real World Evidence, Project/Portfolio Management, Regulatory, Data Science, Quality Compliance and within the U.S. and EU as required ensuring delivery of assigned studies
• May serve as a resource for others within the company for clinical trials management expertise
• Able to examine functional issues from an organizational perspective
• Participates in the recruiting and hiring process for CPA/CTMA/Sr. CTMA and support their professional development
• May contribute to development of abstracts, presentations and manuscripts
• Under supervision, may design scientific communications within the company
• 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
• Travel may be requiredAdditionally may manage and support the following:
  • Investigator Sponsored Research/Collaborative Research studies including Fair Market Value and feasibility assessment, contract milestone advice, tracking and publication follow-up as required
  • Compassionate Use programsKnowledge:
    • Excellent teamwork, communication, decision-making and organizational skills are required
    • Thorough knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies
    • Working knowledge and experience with Word, PowerPoint and ExcelExperience and Skills:
      • At least 5+ years of experience and a BS or BA degree in a relevant scientific discipline
      • At least 3+ years of experience and a Masters' degree or higher; scientific discipline preferredExperience working at a Sponsor or CRO on interventional and/or non-interventional studies requiredFor jobs in the United States:As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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 for assistance.Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.---For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION 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.For Current Gilead Employees and Contractors:Please log onto your Internal Career Site to apply for this job.
        
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Keywords: Gilead Sciences, Inc., San Mateo , Clinical Trials Manager, Executive , San Mateo, California