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Trial Supplies Manager

2+ years
Not Disclosed
10 Feb. 24, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Trial Supplies Manager

Location: Hyderabad, Telangana, India
Department: Global Clinical Supply Chain (GCSC)
Reports To: Senior Manager/Director, Clinical Supply Chain


Job Summary

The Trial Supplies Manager is responsible for creating and maintaining supply strategies for all investigational products, ensuring alignment with regulatory and scientific requirements. The role involves collaborating with cross-functional teams to ensure timely, efficient, and compliant delivery of clinical supplies for global studies.


Key Responsibilities

1. Clinical Supply Chain Management

  • Develop and implement clinical supply strategies to align with study and corporate goals.

  • Collaborate with internal teams (GCSC, R&D, Pharmaceutical Development, Quality, External Vendors, and Medical) to meet supply needs.

  • Define and communicate supply chain strategies for global clinical studies, ensuring optimal use of investigational products.

  • Influence clinical development timelines, study designs, and country selection based on supply chain insights.

  • Ensure compliance with global regulatory and quality requirements.

2. Forecasting & Inventory Management

  • Develop supply forecasts by analyzing clinical development plans and study protocols.

  • Monitor inventory levels and drug utilization, adjusting forecasts as needed.

  • Issue Manufacturing and Packaging/Labeling requests in alignment with study plans.

  • Track investigational drug expiry dates and coordinate Use Date Extension (UDE) activities with logistics teams.

3. Vendor & External Collaboration

  • Oversee Clinical Supply Operations (CSO), ensuring efficient packaging, labeling, and distribution of investigational products.

  • Work closely with Interactive Response Technology (IRT) teams to develop distribution strategies.

  • Support the procurement of commercial drugs, ensuring alignment with country regulations and study needs.

4. Compliance & Risk Management

  • Ensure adherence to Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Distribution Practices (GDP).

  • Support regulatory inspections, audits, and compliance reporting.

  • Identify and implement continuous improvement initiatives for clinical supply processes.

5. Cross-functional Collaboration & Leadership

  • Lead Trial Supply Management meetings, providing insights on risks and mitigation strategies.

  • Act as the primary clinical supply contact for assigned compounds and studies.

  • Support budget planning by maintaining supply and demand estimates.

  • Manage deviations, product complaints, and change controls, collaborating with quality teams.


Qualifications & Experience

Education:

  • Bachelor’s or Master’s degree in Pharmaceutical Sciences, Life Sciences, Supply Chain, or a related field.

Experience & Skills:

  • 2+ years of pharmaceutical industry experience, with at least 1 year in clinical supply chain or clinical development.

  • Strong knowledge of global drug development processes and regulatory requirements.

  • Experience in forecasting, inventory planning, and supply chain operations.

  • Proficiency in Interactive Response Technology (IRT), Clinical Trial Management Systems (CTMS), and related industry tools.

  • Strong project management, analytical, and negotiation skills.

  • Ability to manage conflicts and lead cross-functional teams effectively.

  • Excellent communication and stakeholder management skills.


Work Environment & Travel

  • Hybrid or remote work flexibility, based in Hyderabad, India.

  • Occasional travel may be required for vendor meetings, audits, and study-related activities.


Why Join Bristol Myers Squibb?

At BMS, we are dedicated to transforming patients’ lives through science. Our inclusive, diverse, and innovation-driven culture empowers employees to make a difference in the world of clinical research and pharmaceuticals.

Apply today and be part of a team that’s changing lives!