• Associate Manager, Clinical Operations

    Job Location(s) GT-Guatemala City
    Job Number
    Job Category
    Clinical Trial Management
    Position Type
    Hidden (2052)
  • Job Overview

    This position is located in Guatemala City, Guatemala.


    • Management and conduct of on-site Clinical Quality Control Visits for Clinical Operations staff, including the identification, training and development of CDC Assessors from within Clinical Operations (e.g. Sr. CRAs).
    • Responsible for dotted-line management of CQC Assessors with regard to responsibilities associated with the conduct of CQC visits for Early Clinical Development.
    • Serves as a primary point of contact for EDC to CQC leadership team within the Project Management Office.
    • Responsible for developing and maintaining close ties with Quality Assurance group.
    • Measure performance indicators for assigned staff within Clinical Operations.
    • Escalate potential individuals training needs and assist in the conduct of training and development efforts, regionally.
    • Effectively communicate management strategies, policies and procedures in conjunction with leadership teams.
    • Maintain good working relationships with internal and external clients to ensure opportunity for acquiring additional new business.
    • May be responsible for the supervision of assigned direct reports, which would include:1) responsibility for detailed performance review and management of assigned direct reports including: Annual Performance Management  and Development (PMD), Individual Development Plan (IDP), Line of Sight Goals and "Shoves & Tugs"; 2) responsibility for appropriate management and resolution of performance issues; 3) developing and maintaining effective relationships with management team to manage Clinical Operations Staff in a matrix environment.




    + University/college degree -life sciences preferred or certification in a related allied health

    profession from an appropriately accredited institution (e.g., nursing certification, medical or

    laboratory technology)

    + In lieu of this required educational background the following relevant work history may be


    o Minimum of two (2) years supervisory experience in a health care or clinical research

    setting and

    o Minimum of six (6) years relevant clinical research experience in a pharmaceutical



    + Masters or other advanced degree


    + Relevant clinical research experience in a pharmaceutical company or CRO

    o Individual is proficient with on site monitoring activities (including pre-study,

    initiation, routine monitorRing and closeout visits)

    o Minimum of four ( 4) years relevant clinical research experience in a pharmaceutical


    o Thorough knowledge of drug development process

    o Thorough knowledge of relevant SOPs, ICH, and GCP guidelines

    + Relevant supervisory experience

    o Some experience as a Line Manager or Project Manager preferred

    o Demonstrated ability to lead by example and to encourage team members to seek


    o Proven interpersonal skills

    o Demonstrated ability to successfully participate as a member of a project team

    Demonstrated ability to successfully manage multiple competing priorities

    o Advanced planning and organizational skills

    o Advanced oral, written and presentation skills


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