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Ricerca per "Clinical Trial Supply Manager (f/m/d) 80-100% [34825]"

Clinical Trial Supply Manager (f/m/d) 80-100% [34825]  

Sede

Svizzera, Basilea Città, Basel

Settore:

Industria farmaceutica

Ruolo:

Altro

Data ultimo aggiornamento: 22/06/2022

attività 

Descrizione annuncio

At nemensis ag, we connected thousands of applicants with their dream jobs and gave them the opportunity to develop or re-enter the job market. For our client, an international company in Basel, we are in search for a Clinical Trial Supply Manager (f/m/d).

 

Employment type: Temporary via nemensis ag

Remote work: no

Duration: asap - 31/05/2023

Salary rate: CHF 56 - 62.- / h

 

Your role:

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.
 

Your 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.
  • 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 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 (e.g., labels, packaging, distribution, and comparators).
  • Actively contributes to the GCS sub team 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 e.g., TRD sub team, ICT, etc.


Your Profile:

  • Minimum Bachelor Degree.
  • Experience in the pharmaceutical industry.
  • Fundamental leadership skills.
  • Fluent in English.
  • Analytical / critical thinking enjoying working with data and digital and attention to detail.
  • Basic project management experience.
  • Good organization and planning skills.
  • Demonstrates problem-solving and idea generation skills.
  • Good presentation skills.
  • Very good communication, negotiation, and interpersonal skills.
  • Ability to work in interdisciplinary teams.

 

We look forward to receiving your application!

For further questions please contact:

Annika Schelp, +41 61 205 98 78, Annika.Schelp@nemensis.com

Più dettagli

Tipo di contratto: Lavoro temporaneo

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