IRT Manager - Clinical Supplies & IRT Makro Group

5.0 - 8.0 years

4 - 8 Lacs

Hyderabad, Madhapur

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Key Tasks & Responsibilities: The IRT Manager assumes responsibility for operational execution of the IRT system used in clinical studies in development phases I to IV within clinical operations development operations The IRT is a critical system in ensuring safety of all patients taking investigational medicinal product (IMP,) and if not set-up correctly, could jeopardize the usability of data obtained within the clinical studies. As an expert in IRT, the Manager leads the set-up and testing of the system, ensuring it meets the requirements of the clinical study protocol and that all associated processes are fully compliant with GxP regulations. Revises / develops the clinical study protocol with particular focus on the attributes of study drugs including comparators, medical devices, randomization and blinding. Ensures appropriate supply of study medication for all patients in a clinical trial by implementing optimal IRT supply strategies. The Manager continues to assume accountability of the IRT during the systems life cycle, implementing all required amendments. Leads the IRT cross-functional sub-team and is accountable for the set-up and maintenance of the IRT System with special attention to the proper and correct supply of study sites with study medication, including the correct drug dispensation according to the study protocol. Responsible for providing guidance and training to study teams. Qualifications & Competencies: Bachelors Degree or equivalent. Pharmacist degree preferred 5 to 8 years of relevant healthcare clinical development experience Profound knowledge in drug development Profound knowledge in setting up Interactive Response (IRT) Systems Profound knowledge in GCP and knowledge of GMP Excellent project management skills Excellent communication skills (including fluent English).

Posted 2 days ago

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Clinical Trials Supply Manager Biocon Biologics Limited

9 - 14 years

11 - 21 Lacs

Bengaluru

Work from Office

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.

Posted 2 months ago

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