🔹 Lead end-to-end clinical trial operations, including study planning, execution, monitoring, and closure, ensuring timely delivery of clinical studies.
🔹 Develop and implement study operational strategies while managing clinical study protocols, operational plans, and project timelines.
🔹 Manage clinical vendors/CROs, ensuring effective selection, oversight, quality execution, budget adherence, and timely study delivery.
🔹 Ensure regulatory compliance by maintaining TMF, SOPs, ICH-GCP standards, documentation, and supporting regulatory inspections and audits.
🔹 Review and finalize key clinical documents, including Clinical Trial Protocols, Clinical Study Reports (CSRs), regulatory submissions, and trial documentation.
🔹 Coordinate cross-functional teams to drive study execution, staff training, clinical trial schedules, and overall operational excellence.
🔹 Support quality assurance activities through facility/site audits, document archival, process standardization, and continuous process improvements.
🔹 Lead the Clinical Affairs function by managing team recruitment, training, performance monitoring, and overall departmental operations.