Covance

  • Clinical Team Lead, Ukraine

    Job Location(s) UA
    Job Number
    2018-18841
    Job Category
    Clinical Operations
    Position Type
    Full-Time
  • Job Overview

    You would be responsible and accountable for management of the Clinical Operations team with particular emphasis on teamwork, quality and compliance with the project plans and managing the clinical operations timelines.

     

    Other responsibilities include:

    • Participate in internal project review meetings
    • Ensure that all clinical operations staff allocated to assigned projects adhere to professional standards, ICH/GCP guidelines, project plans and SOPs
    • Responsible for timely and appropriate communication to the clinical operations team
    • Provide performance feedback of team members to respective supervisors
    • Ensure accurate and timely trip report review
    • Follow project issue escalation process and Corrective Action Issue Resolution (CAIR) process for clinical operations issues
    • Responsible for clinical operations Corrective and Preventative Action plans
    • Perform co-monitoring visits when necessary
    • Ensure clinical operations sections of the central TMF are complete
    • Ensure investigator documentation (including IRB/IEC/regulatory documentation) is complete and audit ready
    • Coordinate archival of the central clinical operations and investigator sections of the TMF
    • The CTL may perform other tasks as assigned by the project team

    Education / Qualifications

    • University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution
    • Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
    • Thorough understanding of the drug development process
    • Experience as a Senior Clinical Research Associate, whether internal or external
    • Leadership Competencies
    • Proven relevant clinical research experience with an ability to demonstrate comprehensive understanding of: ICH/GCP guidelines; Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs;Site monitoring and study site management requirements; Applicable regional regulatory requirements; Trip report review, risk planning, study plan development, resource planning and data management oversight.

    Experience

    • Demonstrated ability to work with minimal supervision
    • Demonstrated good planning and organization skills
    • Good computer skills with good working knowledge of a range of computer packages
    • Demonstrated effective and professional verbal and written communication skills
    • Ability to train, lead and develop junior staff
    • Ability to understand and work with financial information
    • Ability to resolve project-related problems and prioritizes workload for self and team
    • Ability to work collaboratively within a project team
    • Ability to work efficiently and effectively in a matrix environment.

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