Covance

  • Centralized Study Associate II (eTMF upload) (Clin Ops)

    Job Location(s) IN-Mumbai
    Job Number
    2019-35509
    Job Category
    Clinical Operations Entry Level
    Position Type
    Full-Time
  • Job Overview

    1. Follow applicable departmental Standard Operating Procedures and Work Instructions.
    2. Complete required trainings according to required timelines.
    3. Manage 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 as needed.
    6. Perform checks to ensure quality of work completed.
    7. Ensure timely escalation and issue resolution.
    8. Track and report metrics as determined by management according to required timelines.
    9. Assist with the implementation of revised processes and procedures.
    10. Other duties as assigned by management.
    • Manage clinical systems
    • Manage study documents
      • Maintain study databases (CTMS, IWRS, EDC etc.

    Education/Qualifications

    Minimum Required:

    Years of experience in the job discipline:2-3 Years

    Years of experience in other professional roles: 0-3 Years

    Other required work-related experiences:

    • Demonstrated ability to organize and communicate effectively.
    • Demonstrated ability to pay attention to detail.

    • Ability to work well with others.

    Experience

    Recommended:

     

    Universiry/College Degree (Life Science preferred) , or certification in a allied health profession from an appropriate accredited institution (E.g Nursing certification, Medical or laboratory  technology) and 0-2 years of work experience in clinical research, including a strong working knowledge of the iCH guidelines and FDA,IRB/IEC regulations.

     

    In Lieu of the above requirement, candidate with one (1) or more years of relevant clinical research experience in Pharmaceutical or CRA Industries may be considered

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