Ritish sharma

Manage global study documentation and eTMF accuracy, oversee TMF setup and reconciliation, and coordinate vendors and CROs to ensure study deliverables and timelines are met across stakeholders.

Conducted IMV/SIV/COV site monitoring, verified clinical data and source documents, supported site selection and training, and managed essential documents and EC dossier submissions to maintain GCP and regulatory compliance.

Monitored site performance through IMV/SIV/COV visits, verified data integrity and regulatory documents, and prepared monitoring visit reports and study progress documentation to ensure protocol adherence.

Coordinated daily clinical trial operations, managed informed consent and participant follow-up, maintained source documents and EDC entries, and submitted regulatory documents to IEC/IRB to ensure data integrity and compliance.

Managed site-level trial operations including consent, participant scheduling, source document maintenance, EDC data entry, and regulatory submissions to ensure protocol compliance and accurate data capture.

Assisted site preparation, supported CTMS data entry and tracking, coordinated meetings and administrative tasks, and helped implement corrective actions to support study readiness and documentation.

Completed an Advanced Post Graduate Diploma in Clinical Research and Pharmacovigilance in 2018 focusing on clinical trial operations and safety reporting.

Earned a Bachelor of Pharmacy degree with coursework in pharmaceutical sciences and clinical trial-related topics.