Shivalee Bade

Manager Regulatory Records (E-tmf) @Syneos Health

Gurgaon, IN

Performing oversight, hiring, training and management of TMF Support Operations team members such as interviewing, selection and task management.• Collaborate between TMF Leads, TMF Operations Strategic Manager, IT and Vendor with study specific EDMS enhancements, electronic TMF transfers.• Participates in bid defense meetings and general capabilities presentations to grow TMF Operations Portfolio of work and providing electronic Trial Master File system demonstrations• Collaborates with client, TMF Lead, and TMF Operations Strategic Manager to establish EDMS processes and metrics to ensure TMF objectives are met• Lead discussions regarding EDMS enhancements, electronic TMF transfers, and bridging with other systems as needed.• Implements processes and manages access/training for the company’s and/or Sponsor electronic Trial Master File technologies.• Oversee systems development, validation and integration work (for incoming/ outgoing data) for quality and integrity, as assigned.• Organize and develop training for department upgrades/enhancements affecting the EDMS and Participate in delivery of training as applicable.• Presents TMF related training effectively to the company’s Sponsor and Vendor project team members.• Applies combination of industry/clinical research and TMF systems knowledge to support end-Users of assigned system(s) according to current support guidelines in a professional and timely manner• Maintains knowledge of assigned system(s) and develops necessary technical skills associated with the system usage, Maintains knowledge and technical skills associated with the usage of the company’s incident management system.• Maintains and continually monitors operational indicators to identify critical business issues and Keeps departmental leadership apprised of emerging/actual issues.• Routinely generate reports for Executive Leadership; drawing conclusions and making recommendations based on expertise.

Indira Gandhi National Open University

Master of Business Administration (MBA), pune

Nucleus Institute of Clinical research

Post graduate diploma in clinical research and regulatory, Pharmacovigilance

KEM Hospital

Post Graduate Diploma in Hospital Managment, Hospitality Administration/Management

S.T College of Pharmacy, Pune

Bachelor of Pharmacy (B.Pharm.), Pharmaceutical Sciences