Pratyaksha Singh

About Pratyaksha Singh

Clinical Research Enthusiast | Honor Society Member | Biotech Maven Passionate…

Experience

1. Records Management Specialist- Archivist

   PharmaLex

   Feb 2024 — Present · Lexington, MA, US

   Support the administration of the Clinical Records Management Programs, ensuring records are managed and maintained according to company policies and procedures, departmental guidelines, and defined retention times and legal holds for our client, Takeda Pharmaceuticals.• Manage the archival and indexing of both critical and non-critical physical records, including processing, maintaining, and tracking document collections. Provide guidance and assistance to staff on record searches and retrieval requests.• Oversee the archiving of Clinical Research physical records stored at external vendors, serving as the primary contact for offsite storage and retrieval of records, with a specific focus on the needs of Takeda Pharmaceuticals.• Manage the on-site clinical records room, ensuring timely access to records and acting as the primary contact for on-site records management.•Facilitate access to records during regulatory inspections, collaborating with Clinical Document Management and Trial Support and other relevant functions, particularly for Takeda Pharmaceuticals.• Actively manage and maintain the electronic archive database, including coordination with vendors on system implementations or updates.• Execute inventories of physical records in accordance with Clinical Records procedures.• Complete all required training satisfactorily, adhering to departmental requirements.