Global Study Manager (m/f/d)
Responsibilities
- Project/Study managers will be responsible for study supply leadership to ensure timely planning and execution of supply strategy for continued supply of clinical finished goods (supply drugs) to patients
- Study managers provides inputs in clinical study protocol, understand study design and are responsible for optimal clinical trial supply strategy in terms of packaging design, pro- active planning following a risk-based approach
- Represent Global Clinical Supply as a single point of contact (SPOC) at trial level for the integrated Clinical Trial team (iCTT)
- 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 (including INDIMPD
Profile
- Practical experience in clinical supplies within the pharmaceutical industry
- IRT (Interavtive Response Technology) system perfect knowledge
- Strong operational excellence with high attention to details
- Broad technical knowledge in appropriate Supply Chain systems used for forecasting and demand planning (solid experience with SAP)
- Data and Digital savviness with high learning ability
- Knowledge of relevant regulations (e.g GMP, HSE etc...)
Benefits
- Growth within the company
- Internationally recognised pharmaceutical company
- Multi-national environment
About Hays
With over 15 years of experience in the pharmaceutical and chemical industry as well as in 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 experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.
Staffing process for freelance specialists
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
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1. Analysis of qualifications
We carry out a detailed analysis of your technical qualifications on the basis of your CV, your application documents and your profile.
Contact at Hays
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