Shivani Kaushal

I am a clinical research professional with 8 years of progressive experience in site management, clinical operations, and feasibility outreach across India. I focus on site startup activities, regulatory submissions, and ensuring sites are inspection-ready and compliant with ICH-GCP.

I have led pre- and post-award feasibility for diverse therapeutic areas, performed remote pre-study visits, and acted as a Site Navigator to build strong site relationships and enable timely study initiation. I use data-driven scoring and tools like UCV and Smartsheet to support accurate oversight.

My experience spans roles at Fortrea Development, IQVIA (Avacare), KlinEra Global Services, and Fortis Hospital, supporting oncology, gastroenterology, ophthalmology, vaccine, and numerous other indications. I have hosted regulatory and accreditation inspections and supported investigators through start-up and monitoring activities.

I bring strong documentation, regulatory, and site engagement skills complemented by proficiency in eTMF, IVRS, eCRF management, and MS Office. I am adaptable, reliable, and committed to delivering compliant, high-quality trial execution.