Covance Job - 31247906 | CareerArc
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Company: Covance
Location: Bengaluru, KA, India
Career Level: Associate
Industries: Healthcare, Pharmaceutical, Biotech

Description

Job Overview:

  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. Ability to work on Multiple studies and prioritize depending on conflicts
  11. Track and report metrics as determined by management according to required timelines.
  12. Proactively identify opportunities for process improvements and lead the implementation of process improvement activities to enhance deliverables.
  13. Support the implementation of tools internally to enhance deliverables
  14. Able to mentor and train others
  15. Work with Global Stakeholders
  16. 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.
  17. Assist in the preparation of new investigator submission packages for site/regulatory submission.
  18. Support study team for contracts and budgets activities for investigative sites including but not limited to Investigatory Payment, Pass through payment processing & tracking
  19. Assist the study start up teams with tasks required for site start up activities.
  20. Review, Support, Manage or assist in Managing the site clinical trial contracts in accordance with defined processes and timelines
  21. Other duties/activities as assigned by study management team, but not limited to:
    • Manage clinical systems
    • Manage study documents and support eTMF management
    • Support study teams to resolve data management queries
    • 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
    • Manage study payments (Site and Vendor) – Ex: Payment reconciliation and release
    • Review study performance dashboard
Education/Qualifications: Recommended:

Universiry/College Degree (Master's 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 6-8 years of work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA,IRB/IEC regulations.

Experience: Minimum Required:

Years of experience in the job discipline: 6-8Years

Years of experience in other professional roles: 0-5Years

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.
  • Ability to use computer and departmental tools.
  • Strong interpersonal skills.
  • Ability to Influence and Lead.
  • Ability to facilitate meetings.
  • Ability to lead process improvement initiatives.


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