Beschreibung
- As a modern company, our client manages to constantly develop further and break new ground.
Clinical Trial Supply Manager NOVJP (m/f)
Reference: -en
Start: asap
Duration: 12 MM++
Main tasks:
- Represent GCS as a core member in the integrated Clinical Trial Team (iCTT); define and advise 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
- Review overall clinical trial protocol/protocol amendments, provide inputs to develop optimal packaging design, clinical trial supply design and visit schedule
- Create and maintain 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
- Create and drive finalization of the packaging design (Clinical Packaging Request) and a comprehensive label strategy for all participating countries in the clinical trial
- Define clinical supply parameters for NIRT set up and initiate subsequent updates throughout the duration of the clinical trial
- Develop and execute a trial-level project plan together with all other relevant roles
- Identifie, assesse and proactively communicate supply risks to all relevant stakeholders along with appropriate mitigation strategies to ensure supply continuity
- Collaborate with all relevant line function partners for country submission and approval timelines (including INDIMPD Amendment) to develop optimal supply strategy
- Generate optimal distribution plans for investigational medicinal products (IMPs), jointly with partner functions
- Trigger and track shipments of IMPs from central depot to regional hubs and local depots
- Develop, maintain and execute 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
- 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
- Ensure adequate, proactive exchange of relevant knowledge and information between the GCS sub team and the CTT
- Fully support, prepare the GCS PL to adequately address GCSconsiderations at various cross-functional teams e.g. TRD sub team, ICT, etc.
Main qualifications
- University degree in science, engineering or equivalent
- Fluent in English
- Profound practical experience in chemical / pharmaceutical industry, solid experience in field of expertise or 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.)
- Demonstrates problem-solving and idea generation skills
- Good presentation skills and fundamental Leadership skills
- Very good communication, negotiation and interpersonal skills. Ability to work in interdisciplinary teams
Main advantages:
- A very renowned company
- A highly motivated team and an open way of communication
- A city with a high quality of life that perfectly embraces both modern and traditional values
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
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