ID EXISTS
POS 3889
Status 5
DJM 1

Clinical Trial Supply Manager

Beschreibung: For one of our Swiss Pharma clients we are seeking temporary support as: Clinical Trial Supply Manager (M/F/*)
K-RECRUITING Life Sciences Personalberatung - flip image
Tasks:
  • 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)
K-RECRUITING Life Sciences Personalberatung - box background image
Qualification:
  • 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 (franziska.spindler@k-recruiting.com // +49 89 189 099 8 51) Skills: Clinical Supply Management, English, GCP (Good Clinical Practice), GMP (Good Manufacturing Practice), Pharma
K-RECRUITING Life Sciences Personalberatung - parallax image
Interesse geweckt?
Auf geht's!
Beginn: 01.09.2020
Laufzeit: 12 months
Einsatzort: Basel
WhatsApp-Service: Mit WhatsApp zum nächsten Projekt!

Bei uns sind Sie richtig. Nicht nur dank perfekt passender Projekte.

UNSERE LEISTUNGEN

Was Sie als Consultant von uns erwarten können.

IHRE VORTEILE

Weshalb sich eine Zusammenarbeit mit uns für Sie lohnt.

WHATSAPP SERVICE

Jetzt registrieren und zukünftig passende Projekte direkt über WhatsApp erhalten.

60
Neu