Hinal Patel

- Coordinated Phase I–III clinical trial activities, ensuring strict protocol and regulatory compliance to facilitate successful outcomes.

- Collaborated with sponsors, CROs, investigators, and study participants, enhancing communication and support for effective trial execution.

- Maintained accurate study documentation, regulatory files, and participant records, streamlining preparation for monitoring visits.

- Coordinated operational activities across 10+ concurrent Phase I–III clinical trials, ensuring study timelines and key milestones were achieved.

Served as primary liaison among sponsors, CROs, investigators, regulatory teams, and internal stakeholders to facilitate effective communication and collaboration.

- Monitored enrollment, study metrics, protocol deviations, CAPA activities, and operational deliverables for leadership reporting to ensure compliance and project visibility.

- Supported study start-up, IRB submissions, regulatory documentation, TMF/eTMF maintenance, and sponsor monitoring visits.

- Collaborated with cross-functional teams to streamline workflows and optimize clinical operations.

- Managed vendor communications, logistics, and scheduling to ensure smooth project execution

- Organized documentation systems and improved tracking processes to ensure timely delivery of project deliverables

- Identified process inefficiencies and implemented improvements to streamline operations and reduce delays

- Supported leadership with reporting, updates, and operational coordination across teams

- Coordinated meetings, prepared agendas, and documented meeting minutes to enhance stakeholder communication