Global Trial Specialist

3 - 8 years

11 - 12 Lacs

Posted:22 hours ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

  • Understands study level tools and plans.
  • Provides support to the GTM along with the appropriate teams for response to country/regulatory and IRB/IEC.
  • Provides operational input and participates in operational processes in support of the startup maintenance and close out of studies.
  • Assist the GTM in driving study execution.
  • Learns, observes and performs core GTS tasks and escalates appropriately.
  • Facilitates vendor creation and payment processing in conjunction with the appropriate stakeholders.
  • Raises possible issues for potential escalation to the appropriate colleagues.
  • Follows instructions, determines level of understanding and seeks clarification when needed.
  • Seeks guidance to navigate undefined tasks, challenges, and study tools/resources.
  • Develops, updates, and submits Transfer of Obligations to Regulatory Authorities.
  • Manages global vendor site lists and resolve issues related to global site lists.
  • Manages study mail-groups/distributions and SharePoint/Study Directory updates.
  • Participates, sets up agendas, and captures meeting minutes in study team meetings for assigned protocols.
  • Identifies issues and risks, develops mitigations, and escalates appropriately.
  • Participates in filing activities and any associated audits as applicable.

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