Clinical Trial Supply Manager

BandLevel 4Job Description SummaryGCS 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 integrated Clinical Trial Team (iCTT). 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 DescriptionMajor accountabilities: Represents GCS as a core member in the integrated Clinical Trial Team (iCTT); defines and advises the iCTT 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 trialDevelops 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 continuityCollaborates with all relevant line function partners for country submission and approval timelines (including IND-IMPD amendment) 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 subteam 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.Key performance indicators: Accountability for quality, quantity and timelines for all assigned tasks/projectsGMP Compliance (number of deviations, technical issues, audit / inspection findings)Adherence to Novartis standards and Values & Behaviors, in particular, quality, ethical, health, safety, and environment standards (HSE), and information security standards (ISEC).Refer to annual individual and team objective Unit KPIs. Cross-functional KPIs (if applicable)Minimum Requirements: ·       Degree in science, engineering or equivalent. ·       >5 years of practical experience in chemical / pharmaceutical industry or > 3 years of experience in field of expertise·       Good expertise in related field. Good knowledge about the Drug Development process·       Basic project management , good organization and planning skills·       Knowledge of relevant regulations (e.g. GMP, HSE etc.) and Novartis specific standards.·       Demonstrates problem-solving and idea generation skills·       Good presentation skills; Fundamental Leadership skills. ·       Very good communication, negotiation and interpersonal skills. Ability to work in interdisciplinary teams.Skills DesiredContinual Improvement Process, Master Data, Materials Management, Materials Requirements Planning (MRP), Production Planning, Project Management, Supply Chain Management (SCM), Supply Chain Planning (SCP), Technical Requirements, Warehouse Management System (WMS)