Clinical Trials Manager

Location
Foster City
Salary
See job description.
Posted
August 07 2021
Ref
R0021367
Position Type
Full Time
Organization Type
Pharma
Job Type
Manager


Clinical Trials Manager
China - Beijing

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible


Management:
  • Mentors junior team members
  • Manages vendors
  • Task management may be required
  • May contribute to employee performance management

    Project Involvement:
  • Manages geographical region(s) of a large complex clinical trial
  • Independently manages all components of a small less complex study
  • Has budget responsibility
  • Independently runs Phase 1 studies
  • Manages cross functional timelines
  • Applicable for biomarker operations
  • Collaborates with local medical affairs colleagues on country specific studies and initiatives
  • Provides knowledge and expertise on country specific regulations and site experience and suitability for development studies

    Key Differentiating Contributions
  • Advanced project management skills adequate to manage the entire process of a clinical trial
  • Ability to identify issues and adapt to changes.
  • Ability to lead cross-functional teams internally and externally
  • Mentors team members
  • Ability to work independently with minimal oversight
  • Will incorporate study logistics and planning to accomplish study objectives

    Job Responsibilities and Skills
  • Must meet all requirements for Sr. CTMA position and have demonstrated proficiency in all relevant areas
  • 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 of CROs/vendors
  • May be asked to train CROs, vendors, investigators and study coordinators on study requirements
  • Contributes to development of study budget
  • 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 CPAs and CTMAs 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
  • Excellent teamwork, communication, decision-making and organizational skills are required
  • Thorough knowledge of FDA and EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies
  • Working knowledge and experience with Word, PowerPoint and Excel
  • Travel is required

    Minimum Education and Experience
  • At least 5+ years of experience and a BS or BA in a relevant scientific discipline



    1-4 SOP

    Management:


    Project Involvement:


    Key Differentiating Contributions


    Job Responsibilities and Skills
    • CTMA
    • /
    • RFPCRO /
    • CRO
    • CPACTMA
    • SOP
    • FDAEMAICHGCP
    • WordPowerPointExcel


    Minimum Education and Experience
    • 5BS BA

    For Current Gilead Employees and Contractors:

    Please log onto your Internal Career Site to apply for this job.


    To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/China---Beijing/Clinical-Trials-Manager_R0021367





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