Clinical Trial Supply Manager, Basel
Posted on Nov 14, 2020 by Michael Bailey Associates - UK Contracts
Our Client, a Global Pharmaceutical who is currently on an exciting growth curve are seeking a Clinical Trial Supply Manager to be based at their Basel site for an initial 12-month contract with a strong likelihood for extension.
Key responsibilities will include:
- 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 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 (eg 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 Global Clinical Supply (GCS) sub team and the Clinical Trial Team (CTT).
- Fully supports, prepares the GCS PL to adequately address GCS considerations at various cross-functional teams eg TRD sub team, ICT, etc.
The successful incumbent will possess:
- University degree in science, engineering or equivalent. Fluent in English
- min. 5 years of practical experience in chemical/pharmaceutical industry, min. 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 (eg GMP, HSE etc.)
Michael Bailey International is acting as an Employment Business in relation to this vacancy.