Clinical Trial Supplies Manager (Denmark) - Sponsor-dedicated

Employer
Syneos Health
Location
Denmark (DK)
Salary
negotiable
Closing date
25 Sep 2020

View more

Discipline
Clinical Research, Clinical Supplies
Hours
Full Time
Contract Type
Permanent
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Clinical Trial Supplies Manager

Sponsor-dedicated

Denmark, Copenhagen

Office-based or home-based

Permanent contract

Job Details:

  • Outsourcing and coordinate clinical trial supplies based on the Trial outline  (TO) for assigned clinical trials
  • Plan and coordinate timelines between relevant parties
  • Ensure optimal collaboration and processes with stakeholders
  • Compile and trace budget for assigned clinical trials
  • Prepare Request for Proposal/Service
  • Ensure protocol is consistent from a trial supplies point of view
  • Review and or approve documents in accordance with departmental Standard Operating Procedures
  • Sourcing/request relevant bulk (Investigational Medicinal Products - IMP, Non- Investigational Medicinal Products or Comparator)
  • Approving study related invoices
  • Determine relevant and correct master label text according to legislation
  • Identify and produce the new SOP´s as applicable
  • Follow up on External Packaging Facilities used for labelling, packaging and distribution
  • Keep up to date with Authorities ‘GMP, GDP and GCP requirements for packaging and distribution and ensure that these requirements are met
  • Participate in relevant cross organizational GMP, GDP and GCP related tasks (e.g. GMP, GDP and GCP committees and inspections)
  • Representing  CTS in relevant Clinical Study Teams, Clinical Focus Teams and Quality Focus Teams
  • Comply with applicable Company Group Policies, Group Guidelines, Standard operating Procedures and Work Instructions
  • Biological IMP expert
  • Participate/Present at Investigator/Monitor Meetings globally
  • Quality management, Temperature handling, Deviations, Change requests
  • Distribution management
  • Ancillary Management,  request for sourcing, set-up
  • MP Management, Forecasting, waste reduction, IMP Handling Manual, Destruction
  • Project Management. Lead optimization projects to benefit GCO
  • Import/Export management
  • Forecast calculations
  • Temperature Deviation expert

Eligibility/Qualifications/Requirements

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

  • MSc. Pharm., Pharmaconomy or similar education or experience
  • Knowledge of GMP, GDP and GCP
  • Fluent in oral and written English
  • Ability to investigation the issues
  • Processing Details
  • Ability to working with structuring tasks
  • Very good communication skills and ability to sharing the necessary information
  • Showing Resilience
  • Ability to building good relationships
  • Stakeholder Focus
  • Integrity and trust

Syneos-header

Syneos Health™ (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry leading companies – INC Research and inVentiv Health – we bring together more than 23,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. To learn more about how we are shortening the distance from lab to life® visit syneoshealth.com.

Please visit our Careers Hub on PharmiWeb.Jobs:www.pharmiweb.jobs/minisites/syneos-careers-hub/

Contact Us
  • Corporate Headquarters
  • 3201 Beechleaf Court
  • Morrisville
  • 27560
  • US
  • +1 919 844 7100
  • Mini-site: Syneos Health
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