Clinical Trial Supply Manager (Hyderabad)

Clinical Trial Supply Manager (Hyderabad)

16 Aug
|
Novartis
|
Hyderabad

16 Aug

Novartis

Hyderabad

Job Description 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.

Job Description
Major Accountabilities
Represents 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 st

📌 Clinical Trial Supply Manager (Hyderabad)
🏢 Novartis
📍 Hyderabad

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