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Clinical Trial Supply Manager
Eingestellt von Michael Bailey Associates - Zurich
Gesuchte Skills: Design
Projektbeschreibung
We are searching for the experienced clinical trial supply manager to define and execute clinical trial supply strategy for projects in the assigned area.
Tasks:
- Defines and advises 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 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 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 external cost (eg labels, packaging, distribution and comparators).
- Actively contributes to the subteam as a full member. Ensures adequate, proactive exchange of relevant knowledge & information
Requirements:
Life Sciences Degree
5 years of practical experience in chemical/pharmaceutical industry
Good expertise in related field.
Good knowledge about the Drug Development process
project management, good organization and planning skills
Knowledge of relevant regulations (eg 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.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Tasks:
- Defines and advises 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 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 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 external cost (eg labels, packaging, distribution and comparators).
- Actively contributes to the subteam as a full member. Ensures adequate, proactive exchange of relevant knowledge & information
Requirements:
Life Sciences Degree
5 years of practical experience in chemical/pharmaceutical industry
Good expertise in related field.
Good knowledge about the Drug Development process
project management, good organization and planning skills
Knowledge of relevant regulations (eg 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.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design