Covance

  • Centralized Study Specialist I (eTMF Periodic review) (Clin Ops)

    Job Location(s) IN-Mumbai
    Job Number
    2019-35530
    Job Category
    Clinical Operations Management
    Position Type
    Full-Time
  • Job Overview

    Job Location: Mumbai, India

     

    Essential Job Duties: 

    1. Follow all applicable departmental Standard Operating Procedures and Work Instructions.
    2. Complete required trainings according to required timelines.
    3. Complete day-to-day tasks ensuring quality and productivity.
    4. Manage project and technical documentation in an appropriate manner.
    5. Provide administrative and technical support to internal departments and teams as needed.
    6. Perform checks to ensure quality of work completed.
    7. Ensure timely escalation and issue resolution as needed.
    8. Execute high quality, timely monitoring and reporting plan(s) including specialized monitoring requests for approved protocols
    9. Support implementation of new monitoring tools
    10. Track and report metrics as determined by management according to required timelines.
    11. Proactively identify opportunities for process improvements and support the implementation of process improvement activities.
    12. Support the implementation of tools internally to enhance deliverables
    13. Ability to mentor and train others
    14. Assist in the document management (including document template creation, collection, review, processing and tracking up to eTMF filing) for all documents in the scope of agreed processes/activities or within the scope of GSDM throughout the study duration.
    15. Assist in the preparation of new investigator submission packages for site/regulatory submission.
    16. Support study team for contracts and budgets activities for investigative sites
    17. Assist the study start up teams with tasks required for site start up activities.
    18. Review, Support, Manage or assist in Managing the site clinical trial contracts in accordance with defined processes and timelines
    19. Other duties/activities as assigned by study management team, but not limited to:
      • Manage clinical systems
      • Manage study documents and support eTMF management
      • Maintain study databases (CTMS, IWRS, EDC etc.)
      • Track and follow up with CRAs for outstanding issues
      • Support in generating the study specific reports.
      • Manage internal/external communications
      • Assist in ensuring training compliance for study teams
      • Assist in study payments (Site and Vendor)

    Education/Qualifications

     

    University/College Degree (Life Science preferred), or certification in an allied health profession from an appropriate accredited institution (Ex: Nursing certification, Medical or laboratory technology) and 05-08 years of work experience in clinical research, including a strong working knowledge of the ICH-GCP guidelines and all other applicable guidelines and regulations.

    In addition to above, Candidates without life sciences background but with relevant domain knowledge or experience may be considered, if deemed appropriate for specific tasks and activities.

     

    Experience

    Minimum Required:

    1. Years of experience in the job discipline: 05-08 Years
    2. Years of experience in other professional roles: 00-05 Years
    3. Other required work-related experiences:
    • Demonstrated ability to plan, prioritize, organize and communicate effectively.
    • Demonstrated ability to pay attention to detail.
    • Strong interpersonal skills with ability to work well with others.
    • Ability to deliver consistent high quality of work.
    • Strong interpersonal skills.
    • Ability to Influence others.
    • Ability to facilitate meetings.
    • Ability to lead process improvement initiatives

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