POS 3889
Status 5

Clinical Trial Supply Manager

Beschreibung: For one of our Swiss Pharma clients we are seeking temporary support as: Clinical Trial Supply Manager (M/F/*)
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  • 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
  • Single point of contact at trial level for the integrated Clinical Trial Team (iCTT)
  • 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
  • Ensure compliance of processes with regulations as well as internal procedures and GxP requirements
  • Give guidance to team members. Provide coaching and technical training as subject matter expert or recognized technical expert. Act as mentor for junior and senior associates
  • Monitor and report Key Performance Indicators (KPI) and performance measures to enable strategic objectives to be met, or corrective action to be taken
  • Reviews overall clinical trial protocol/protocol amendments, provides inputs to develop optimal packaging design, clinical trial supply design and visit schedule
  • Creates and drives finalization of the packaging design (Clinical Packaging Request) and a comprehensive label strategy for all participating countries in the clinical trial
  • Collaborates with all relevant line function partners for country submission and approval timelines (including IND-IMPD amendment) to develop optimal supply strategy
  • Accountability for quality, quantity and timelines for all assigned tasks/projects
  • GMP Compliance (number of deviations, technical issues, audit / inspection findings)
  • Adherence to standards and Values & Behaviors, in particular, quality, ethical, health, safety, and environment standards (HSE), and information security standards (ISEC)
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  • Bachelor or master’s degree in science, engineering or equivalent
  • 5 years of practical experience in chemical / pharmaceutical Industry
  • 10 years of experience in field of expertise
  • Strong GMP, GCP experience, ideally with clinical supply experience
  • Strong SAP experience, system savvy
  • Strong planning skills, operational excellence & discipline
  • Good knowledge about the Drug Development process
  • Basic project management
  • Knowledge of relevant regulations (e.g. GMP, HSE etc.)
  • Fundamental Leadership skills
  • Languages: Fluent in English
Bemerkungen: Bitte kontaktieren Sie Franziska Spindler ( // +49 89 189 099 8 51) Skills: Clinical Supply Management, English, GCP (Good Clinical Practice), GMP (Good Manufacturing Practice), Pharma
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Interesse geweckt?
Auf geht's!
Beginn: 01.09.2020
Laufzeit: 12 months
Einsatzort: Basel
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