Clinical supply Chain Manager

Role: Clinical Supply Chain Manager

Skill: End-to-end clinical supply chain management

Mode: Homebased

Experience: 5- 10 years

Job Location: Hyderabad/Bangalore/Mumbai

Educational Qualification: BE + MBA/PGDM ,BPharm + MBA/PGDM, Science degree + MBA/PGDM

Job Overview

The Clinical Supply Chain Manager is responsible for the strategic planning and execution of new clinical trial supply chains. This involves the ability to interpret a clinical trial protocol in conjunction with other key study information in order to create an appropriate kit design and formulate a strong supply plan. The Clinical Supply Chain Manager will lead internal and external partners, to ensure delivery of the supply plan in accordance with study timelines.

Essential Functions
• Interpret clinical trial protocols to create and execute an effective clinical trial supply chain solution
• Create master English label text in accordance with relevant regulatory framework (e.g. Annex 13)
• Create and maintain demand forecasts and packaging plans so that packed clinical supplies are readily available in accordance with the project requirements
• Initiate packaging campaigns with the assigned vendor and provide oversight to ensure on-time delivery
• Setup, monitor, and where necessary, update study assigned Interactive Response Technology (IRT) systems to ensure study inventory is effectively managed
• Create an appropriate distribution plan and have oversight of the assigned vendor(s) executing it
• Ability to work independently and proactively to ensure that the supply of all trial materials is delivered to the right place at the right time
• Provide ongoing budget tracking activities so that projects are run efficiently and in accordance with client approved quotations
• Maintains 100% compliance on all assigned training and applies learnings to everyday practice
• Remain up to date in all GxP and regulatory requirements applicable to the role
• Leads client and vendor related meetings where necessary to discuss clinical supply chain topics or status updates
• Creates a Temperature Excursion management plan
• Manages the review and assessment process of Temperature Excursions reported to the IQVIA Clinical Trial Supplies team
• Conducts thorough and regular risk management assessments to ensure all risks are systematically reviewed and appropriate mitigations are executed

Qualifications
• Bachelor's Degree Degree in a science or business function (Preferred not essential) Req
• 5-10 Years related industry experience in Clinical Trials (Essential).
• 5-10 Years experience in Clinical Supply Chain Management (Essential).
• Ability to demonstrate good project management skills.
• Ability to create effective working relationships with internal and external stakeholders.
• Ability to demonstrate effective communication and direction.
• Ability to problem solve.
• Strong Microsoft Office skills (Word, Excel, PowerPoint etc).
• Proficient in the English language.

The ideal candidate should have experience in:
• End-to-End Clinical Supply Chain Management: Including study protocol interpretation, demand forecasting, supply, and distribution planning, managing labelling, primary/secondary packaging, and release-related activities.
• Exposure to IRT/IWRM/IVRS: Set-up, UAT, and working knowledge to manage day-to-day activities.
• Knowledge of GxP Guidelines.
• Experienced in working with CMOs/CDMOs & 3rd party logistic partners (3PLs)