Highlights
Creates and maintains complete and accurate clinical supply demand for assigned study in alignment with protocol requirements, key study parameters and milestones, patient projections, with appropriate overage and by using defined processes and systems. Major AccountabilitiesRepresents GCS as a core member in the Clinical Trial Team (CTT); defines and advises the CTT on the optimal clinical trial supply strategy in terms of, but not limited to, packaging design, technical and timeline feasibility, efficiency, and risk management.
Numbers & Facts
| Location | East Hanover, NJ |
| Industry | Biotechnology/Pharmaceuticals |
| Company Size | 10,000 employees or more |
| Year Founded | 1996 |
Description
Job ID
REQ-10085514
Aug 15, 2026
India
Available in: English
Summary
Clinical Trial Supply Manager (CTSM) defines and executes an optimal clinical trial supply strategy for a clinical trial including effective risk management to ensure supply continuity to patients.The CTSM is the GCS single point of contact at trial level for the respective core CTT (Clinical trial team) and/or CTT Sub-Team they represent, as standing member or contributing expert. The CTSM is responsible for clinical trial supply deliverables within GCS and all other relevant associated sub-functions, maintaining Quality and Compliance through all activities.Has operational end to end responsibility for assigned activity. Leads and manages all project and local network activities and participates in cross-functional teams.
About the Role
Major AccountabilitiesRepresents GCS as a core member in the Clinical Trial Team (CTT); defines and advises the CTT on the optimal clinical trial supply strategy in terms of, but not limited to, packaging design, technical and timeline feasibility, efficiency, and risk management.Reviews overall clinical trial protocol/protocol amendments, provides inputs to develop optimal packaging design, clinical trial supply design and visit schedule.Creates and maintains complete and accurate clinical supply demand for assigned study in alignment with protocol requirements, key study parameters and milestones, patient projections, with appropriate overage and by using defined processes and systems.Creates and drives finalization of the packaging design (Clinical Packaging Request) and a comprehensive label strategy for all participating countries in the clinical trial.Defines clinical supply parameters for IRT set up and initiates subsequent updates throughout the duration of the clinical trial.Develops and executes a trial-level project plan together with all other relevant roles.Identifies, assesses, and proactively communicates supply risks to all relevant stakeholders along with appropriate mitigation strategies to ensure supply continuity.Collaborates with all relevant line function partners for country submission and approval timelines to develop optimal supply strategy.Generates optimal distribution plans for investigational medicinal products (IMPs), jointly with partner functions. Triggers and tracks shipments of IMPs from central depot to regional hubs and local depots.Develops, maintains, and executes an optimal resupply strategy with proactive planning, appropriate lead-time, and replenishment quantities to ensure compliance and continuity of clinical supplies, including proactive expiry management of clinical supplies.Is responsible to consolidate, maintain and track the clinical trial budget with key stakeholders for overall GCS external cost (e.g., labels, packaging, distribution, and comparators).Actively contributes to the GCS sub team as a full member. Ensures adequate, proactive exchange of relevant knowledge & information between the GCS sub team and the CTT. Fully supports, prepares the GCS PL to adequately address GCS-considerations at various cross-functional teams e.g., TRD sub team, ICT, etc.Minimum Requirement>5 years of practical experience in clinical supplies within the pharmaceutical industryStrong operational excellence with high attention to detail. Advanced project management, good organization, and planning skillsBroad technical knowledge in appropriate Supply Chain systems used for forecasting and demand planning (minimum 3 years of expertise with SAP). Data & Digital savviness with high learning agilityKnowledge of relevant regulations (e.g., GMP, HSE etc.)Master's or Doctorate in life sciences (or MBA with bachelor's degree, or equivalent experience in life science)
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-cultureBenefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally.Read our handbook (PDF 30 MB)
Division
Development
Business Unit
Development
Location
India
Site
Hyderabad (Office)
Company / Legal Entity
IN10 (FCRS = IN010) Novartis Healthcare Private Limited
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regular
Shift Work
No
Accessibility and accommodationNovartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Research & Development Development India
Job ID
REQ-10085514
Clinical Trial Supply Manager
Apply to Job
Job ID
REQ-10085514
Clinical Trial Supply Manager
Apply to Job
About Company
Novartis provides healthcare solutions that improve and extend people’s lives. We use science-based innovation to address some of society’s most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible. Our company is focused on industry-leading divisions with innovation power and global scale: pharmaceuticals, eye care and generic medicines Novartis is headquartered in Basel, Switzerland. Novartis Group companies employ approximately 120,000 associates and its products are available in more than 180 countries around the world.