Sandesh Mohole

About Sandesh Mohole

Over a decade and a half of experience in the pharmaceutical sector, focusing on…

Experience

1. Manager, Cdma - Clinical Operations (Ctsm)

   Biocon Biologics

   Jun 2024 — Present

   Evaluation and Selection of vendors/service providers for supply management and provide oversight throughout.Managing vendor qualification process, and proper communication handling between sites, sponsor and management team for clinical trial supplies.Forecast clinical (Investigational and comparator, other Products) and ancillary (non-drug product) supply requirements and lead independently all aspects of trial supplies for assigned clinical trials.Liaise with internal functions of Biocon and external partners and providers (CRO, others) in driving the clinical supplies shipments.Oversee set up of IXRS tools, monitor the supply utilization, accountability, and reconciliation throughout the trial and destruction processes completed after trial completion.Reviews clinical trial protocol and develop packaging design according to clinical trial supply design and visit schedule. Co-ordinate and review the Product labels to be used for primary and secondary labeling including expiry date extension if any and oversee the label design and approval processes.Oversee the procurement of comparator and any additional drug products as required for clinical trials with necessary documents.Oversee and monitor drug product expiry and re-supply strategyDevelops contingency planning and risk mitigation strategies to ensure successful provision of all required clinical trial vendors.Monitor temperature excursion(s), and co-ordinate for necessary approvals as needed.Drive inventory of trials at depot level for each country/ region.Create or update SOPs required for clinical trial supply management.

Education

• University of Mumbai

  Bachelor of Pharmacy - BPharm