Global Project/Study Manager (m/f/d)

Global Project / Study Manager

m / f / d)

Freelance / temporary employment for a project Basel Stadt Start date : asap Reference number : 774908 / 1

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Responsibilities

• 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 comprehensivelabel 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.

Develop and execute 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 (including INDIMPD 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 ( labels, packaging, distribution and comparators)

Profile

• Solid 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
• Solid SAP experience
• Data & Digital savviness with high learning ability
• Knowledge of relevant regulations ( GMP, HSE etc...)
• Accountability and Leadership
• IRT (Interactive Response Technology) system knowledge

Benefits

• Very renowned pharmaceutical company
• International environment
Vor 30+ Tagen