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Clinical Supply Project Coordinator

Employer
Planet Pharma Staffing Limited
Location
Wavre
Salary
Competitive Hourly Rate
Start date
23 Oct 2019
Closing date
8 Nov 2019

Job Details

Overview of Project 

The Clinical Supply Project Coordinator will be accountable for the coordination and implementation of the sponsor name change activity linked to IMP supply. You will coordinate and communicate the necessary activities for all impacted departments during this change. You will work closely with Master Planners to implement the strategy defined in collaboration with stakeholders and provide visibility on the progress on a monthly basis.

Scope: All clinical trials (phase 1-4)

 

Responsibilities:

  • In alignment  with the sponsor name change implementation deadline and the IMP production plan provided by the master planner, build the implementation plan for Packaging Operations
  • Collect input from Regulatory department regarding the protocol amendment timelines and planned submission dates per country and incorporate these information in the implementation plan
  • Provide monthly updates per study and share visibility on the progress to the Clinical, Regulatory, Legal and Clinical Trial Supplies  Departments
  • Follow up on all activities defined in the change control for this project
  • Proactively identify and highlight issues to the key stakeholders
  • Uses project management techniques to manage effectively and efficiently the sponsor name change project for all impacted  studies
  • Creates and maintains project plans, defining and achieving through the lead of crossfunctional teams the planned milestones regarding the  activities including packaging, labeling, distribution and other supply systems
  • Secures optimal transfer of information
  • Drives strong partnership with stakeholders (CTS functions, Clinical Team, Global Distribution and Logistics (GDL), QA, Legal, Regulatory), participating/leading all required meetings as a liaison for CTS
  • Supply Chain Expertise: understands key supply chain processes and can balance cost and service to patients, including advanced understanding of the regulatory and GxPs requirements for IMP's as well as clinical trial distribution particularities

 

Requirements:

  • Pharmaceutical supply chain knowledge including labelling and label change experience
  • Advanced understanding of the regulatory and GxP requirements for IMP's as well as clinical trial distribution particularities
  • Experience planning and orchestrating Projects and are able apply project management techniques in day to day activities
  • Augmented Analytics: is able to build queries and summarize data

 

To apply 
If you would like to discuss this vacancy further or to discuss your career options in confidence, please call Tiffany Gardner on 02039288385 or email: tgardner@planet-pharma.co.uk

If this role isn’t suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!

 

About Planet Pharma
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

www.planet-pharma.com

Company

Planet Pharma was founded by a dedicated team of professionals with extensive experience supporting the pharmaceutical, biotechnology, and device industries.

Our goal is to create an organization that strengthens the employer-employee dynamic by connecting clients with talent. This results in making staffing more personal and creating enduring, valuable relationships. We value communication with our clients and make it our priority to have the hiring process be as fast and successful as possible.

We leverage cutting-edge technology and flexible service delivery models that provide efficient, personalized solutions for your business.

Our global headquarters is in Northbrook, IL and branch offices are based across the United States and Europe.

Company info
Website
Telephone
+44 203 868 1000
Location
10 Greycoat Place
London
England
SW1P 1SB
United Kingdom

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