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Clinical Trial Supplies Manager (Denmark) - Sponsor-dedicated

Description

Clinical TrialSupplies Manager

Sponsor-dedicated

Denmark,Copenhagen

Office-based or home-based

Permanentcontract

Here at SyneosHealth we are currently recruiting for a Clinical Trial Supplies Manager to workfor one the world’s leading Pharmaceutical companies. The ClinicalTrial Supplies Manager (CTSM) will be responsible for management of theclinical trial supplies.

JobDetails:

  • Outsourcing and coordinate clinical trial suppliesbased on the Trial outline(TO) forassigned clinical trials
  • Plan and coordinate timelines between relevantparties
  • Ensure optimal collaboration and processes withstakeholders
  • Compile and trace budget for assigned clinicaltrials
  • Prepare Request for Proposal/Service
  • Ensure protocol is consistent from a trial suppliespoint of view
  • Review and or approve documents in accordance withdepartmental Standard Operating Procedures
  • Sourcing/request relevant bulk (InvestigationalMedicinal Products - IMP, Non- Investigational Medicinal Products orComparator)
  • Approving study related invoices
  • Determine relevant and correct master label textaccording to legislation
  • Identify and produce the new SOP´s as applicable
  • Follow up on External Packaging Facilities used forlabelling, packaging and distribution
  • Keep up to date with Authorities ‘GMP, GDP and GCPrequirements for packaging and distribution and ensure that these requirementsare met
  • Participate in relevant cross organizational GMP,GDP and GCP related tasks (e.g. GMP, GDP and GCP committees and inspections)
  • RepresentingCTS in relevant Clinical Study Teams, Clinical Focus Teams and QualityFocus Teams
  • Comply with applicable Company Group Policies, GroupGuidelines, Standard operating Procedures and Work Instructions
  • Biological IMP expert
  • Participate/Present at Investigator/Monitor Meetingsglobally
  • Quality management, Temperature handling,Deviations, Change requests
  • Distribution management
  • Ancillary Management,request for sourcing, set-up
  • MP Management, Forecasting, waste reduction, IMPHandling Manual, Destruction
  • Project Management. Lead optimization projects tobenefit GCO
  • Import/Export management
  • Forecast calculations
  • Temperature Deviation expert
  • Qualifications

    Eligibility/Qualifications/Requirements

    The ideal candidate will need the followingexperience / skills to be considered:

  • MSc. Pharm.,Pharmaconomy or similar education or experience
  • Knowledge of GMP, GDPand GCP
  • Fluent in oral andwritten English
  • Ability to investigationthe issues
  • Processing Details
  • Ability to working withstructuring tasks
  • Very good communicationskills and ability to sharing the necessary information
  • Showing Resilience
  • Ability to building goodrelationships
  • Stakeholder Focus
  • Integrity and trust
  • We have a comprehensive benefits package andoffer highly competitive remuneration.

    If you have the required experience for this position and are eligible to workin the required location then please apply by CV.

    To find outmore about our company and search and apply for other open jobs please visitour website


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