Associate Srs 1

5 days ago

Thane, India IQVIA Full time

Manage and oversee a caseload of visit report reviews for assigned studies, ensuring compliance to the protocol, processes, timelines, IQVIA applicable SOPs, and GCP guidelines independently.
- Lead a comprehensive review of the visit reports in order to ensure all site issues are adequately documented, reported and followed up to resolution, as well as, assuring a high quality of SVRs.
- Develop, in collaboration with CLs at project start-up and throughout the study, site visit report annotations, guidelines, and assure efficient completion of visit reports by the CRAs.
- Provide training for CRAs of study site visit report annotations and reports writing.
- Manage and oversee the project team compliance to SOPs for submission and approval of the visit report through direct communication with the CRA.
- Review the visit reports to ensure documentation and implementation of e.g. audit or inspections, findings or focused site visit observations requiring corrective and /or preventative action plans.
- Attend regular teleconferences with CTMs to discuss any SVR review issues illustrative of quality/performance deficiencies across PIs/sites and CRAs in a given project. Assist the CTMs with review of the trends emerging from the Issues observed.
- Work with the project team members to decrease the level of corrections/additions needed on reports, provide continuous support to CRAs with regard to reports’ writing requirements, providing ongoing mentoring, coaching and better understanding of the SVR annotations.
- Work with CRAs and study teams to support Open Action Items Management.
- Provide additional team SRS support through other activities such as quality checks, data trending, providing back up support, mentoring and coaching of junior SRSs.

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