Job Description

CDMA-Clinical Trials Supply Manager- Job Description 1. Lead & keep oversight independently all aspects of the clinical trial supplies for assigned clinical trials. 2. Evaluation and Selection of vendors/service providers for clinical trial supply management. 3. Oversee set up of IxRS tools, monitor the supply utilization, optimization, resupply, accountability, re-conciliation throughout the trial and destruction processes completed after trial completion. 4. Forecast clinical (Investigational and comparator, other Products) and ancillary (non-drug product) supply requirements. 5. Calculate clinical supply requirements and provide the requirements to internal team for supply readiness proactively. 6. Oversee the procurement of comparator and any additional drug products as required for clinical trials with necessary documents. 7. Co-ordinate and review the packaging & labelling activities including design of Product labels and expiry extension if any and oversee the label design and approval processes. 8. Liaise with internal functions of Biocon and external partners and providers (CRO, others) in driving the clinical supplies shipments and monitor the temperature excursions accordingly. 9. Create or update SOPs required for clinical trial supply management.