Shilpa Mandava

Organize and maintain Trial Master Files/eTMFs across studies, lead TMF transfers and inspection readiness activities, and drive TMF health, milestones, access and purchase request processes to ensure regulatory compliance.

Owned eDMS release management and acted as CDGM liaison to deliver compliant eDMS releases, drive backlog prioritization, manage incidents/changes and support audits and CAPA activities to improve system operations.

Led records management projects, coordinated document retrieval and study transfers, trained staff on records policies, and ensured filing accuracy and compliance with SOPs and client file plans.

Maintained Central Files and electronic document systems, ensured TMF completeness prior to study close/export, and supported EDC user management and quality control procedures.

Led records management projects including retrievals and closed-study transfers, trained teams on file plans and SOPs, and managed inventory, transfers and disposition of study records.

Reviewed project-specific documents for quality, led work allocation and quality checks, mentored team members and maintained project communications and documentation to meet timelines.

Processed study documents per SOPs, handled receipt, scanning, indexing and archiving activities, supported audits and client requests, and contributed to departmental reporting.

Managed protocol familiarity, participant screening and consent processes, coordinated participant procedures and data collection, and maintained site study documentation and timelines.

Completed a Post Graduate Certificate course in Clinical Research Management focusing on clinical trial processes and regulations.

Graduated with a degree in biotechnology covering core subjects in molecular biology, genetics, and bioprocessing.