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Clinical Trial Supply Manager
2 weeks ago
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
Main activities
- 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 NIRT 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.
Experience/Professional requirement:
5 years of practical experience in clinical supplies within the pharmaceutical industry.
- Strong operational excellence with high attention to details.
- Advanced project management, good organization, and planning skills.
- Broad 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 agility
- Knowledge of relevant regulations (e.g., GMP, HSE etc.) and Novartis specific standards.
