Senior Clinical Site Quality Manager

1 week ago

Davangere, Karnataka, India beBeeClinicalResearchAssociate Full time ₹ 5,00,000 - ₹ 10,00,000
Site Report Specialist

The Site Report Specialist plays a critical role in ensuring the quality and integrity of site visit reports. They review SVRs to ensure compliance with IQVIA SOP, ICH/GCP guidelines, and protocol requirements.

Key Responsibilities:
  • Oversee a caseload of SVRs for assigned studies, ensuring compliance to the protocol, processes, timelines, IQVIA/applicable SOPs, and GCP guidelines.
  • Provide guidance to Clinical Project Managers (CPMs) at project start-up and throughout the study and partner with the project team members to decrease the level of corrections/additions needed on reports by providing insight and training of the SVR annotations.
  • Provide coaching to CRAs to decrease the level of corrections/additions needed on reports.
  • Identify and track the project team compliance to SOPs for submission and approval of the SVRs through communication with the CRAs and line managers.
  • Participate on the project team for all SVR review activities and identifies and escalate CRA and/or site issues, relevant trends, and related risk factors to the project team and appropriate parties in a timely manner to optimize quality of project delivery.
Required Skills and Qualifications:
  • 4-6 years relevant experience as a Clinical Research Associate.
  • Minimum of 3 to 4 years on-site monitoring experience.
  • Basic therapeutic and protocol knowledge.
Benefits:

This is an exciting opportunity for experienced Clinical Research Associates to develop their skills and advance their careers.

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