Clinical Trial Supply Manager

Beschreibung

Job title: Clinical Trial Supply Manager

The Clinical Trial Supply Manager (CTSM) defines and executes an optimal clinical trial supply strategy for a clinical trial including effective risk management to ensure supply continuity to patients. The CTSM is the single point of contact in GCS (Global Clinical Supply) at trial level for
the integrated Clinical Trial Team (iCTT). Is responsible for clinical trial supply deliverables within GCS and all other relevant associated sub-functions, maintaining Quality and Compliance through all activities. Has operational end to end responsibility for assigned activity. Leads and manages all project and local network activities and participates in cross-functional teams.

Major accountabilities
1. 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.
2. Reviews overall clinical trial protocol/protocol amendments, provides inputs to develop optimal packaging design, clinical trial supply design and visit schedule.
3. 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.
4. Creates and drives finalization of the packaging design (Clinical Packaging Request) and a comprehensive label strategy for all participating countries in the clinical trial.
5. Defines clinical supply parameters for NIRT set up and initiates subsequent updates throughout the duration of the clinical trial
6. Develops and executes a trial-level project plan together with all other relevant roles.
7.Identifies, assesses and proactively communicates supply risks to all relevant stakeholders along with appropriate mitigation strategies to ensure supply continuity
8. Collaborates with all relevant line function partners for country submission and approval timelines (including INDIMPD
amendment) to develop optimal supply strategy.

>And much more included!

Minimum requirements:
University degree in science, engineering or equivalent. Fluent in English
1. min. 5 years of practical experience in chemical / pharmaceutical industry, min. 3 years of experience in field of expertise
2. Good expertise in related field.
3. Good knowledge about the Drug Development process
4. Basic project management , good organization and planning skills
5. Knowledge of relevant regulations (e.g. GMP, HSE etc.)
8. Fundamental Leadership skills.

Michael Bailey International is acting as an Employment Business in relation to this vacancy.