GCS Clinical Trial Supply Manager

Only English-written CV will be accepted.

Please note that only selected candidates will be contacted.

For our Client in BASEL, we are looking for a GCS CLINICAL TRIAL SUPPLY MANAGER, for a 12 MONTHS contract.

Duration: 01/07/2018 to 30/06/2019

Location: Basel

Workload: 100%

Job Purpose:

GCS 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.

Major Responsibilities:

- 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.
- Develops and executes a trial-level project plan together with all other relevant roles.
- 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 GCS external cost (eg labels, packaging, distribution and comparators).
- Actively contributes to the GCS subteam as a full member. Ensures adequate, proactive exchange of relevant knowledge & information between the GCS sub team and the CTT.
- Fully supports, prepares the GCS PL to adequately address GCS-considerations at various cross-functional teams eg TRD sub team, ICT, etc.
- Proactively communicate key issues and any critical topic in a timely manner to the appropriate management level and to/or any other relevant project team members. Interpret results, evaluate data, draw conclusions and report back to team and management.

Candidate's Profile:

Languages: Fluent in English

Experience:

- 5 years of practical experience in chemical/pharmaceutical industry
- 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.)
- 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.

Education: Degree in science, engineering or equivalent.

For further details please contact Aleksandra Sztajerowska.