Pooja Sharma

I've supported global clinical studies at SIRO Clinpharm, managing study start-up activities, regulatory documentation, and Trial Master Files from activation through closeout.

As a Site Manager, I coordinated sponsors, CRAs, project managers, CROs, and study teams to collect, review, and file essential documents. I maintained TMF plans, indexes, expected document lists, and trackers while supporting CTMS and Veeva Vault eTMF activities.

Previously, I prepared inspection-ready eTMFs, supported ethics committee submissions, site initiation preparation, audits, closeout, and financial reconciliation. I also trained new Document Management Associates and contributed to SOP and process-improvement initiatives.

My clinical research experience includes hospital-based study coordination at Kokilaben Dhirubhai Ambani Hospital and studies across oncology, cardiology, rheumatology, pulmonology, neurology, gastroenterology, and medical devices. I bring a strong focus on ICH-GCP compliance, document quality, and accurate study records.