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Job Details

Contract *** Clinical Supply Set-Up Manager *** 12 months’ interim opportunity in Brussels

Company: Advanced Regulatory (UK & Europe)
Location: Belgium, Brussels
Reference: Oli/10368
Closing Date: 06 Aug 18
Type: Contract
Salary (£): On Application
Benefits: On Application

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Job Summary:

We have an Interim Clinical Supply Set-Up Manager vacancy based in Brussels. This is a 1-year contract opportunity. If you wish to apply for this role, please send your CV with a covering note to oli.dimitrov@advregulatory.com or alternatively, call Oli in the London office on +44 (0)20 7801 3388.

Requirements:

We have an urgent requirement for a Clinical Supply Set-Up Manager. This is a Contract opportunity to be part of a global pharmaceutical company that develops, manufactures, packages and distributes over-the-counter and prescription pharmaceuticals, nutritional products, active pharmaceutical ingredients and consumer products.

The role is based in Brussels, it is for 12 months with the possibility for an extension.

The Clinical Supply Set-Up Manager is accountable for the project management of the set-up of study supply and new capabilities at CTS

He/she plans, coordinates and communicates clinical supply activities for all applicable clinical trials during their set-up phase, aiming to achieve optimal quality, time and budget.

He/she implements the strategy defined in collaboration with stakeholders and provides visibility on clinical supply chain during trial set-up.

Scope: All clinical trials (phase 1-4) + Compassionate Use Programs (EAP/NPP/MAP) with CTS involvement + Investigator Initiated Trials/Studies (IIT/ISS) with CTS involvement.

Major accountabilities:

Study Supply Strategy definition and implementation

  • Gathers and challenges clinical and supply assumptions to trigger the study supply optimization.
  • With guidance of Clinical Supply Lead and Optimization experts, defines an optimal IMP supply strategy to ensure adequate and sufficient forecasting of IMP. Establish production plan, distribution plan and IRT settings for the start of the study.
  • Provides input to protocol content, country selection and clinical risk databases.
  • Defines or selects packaging configuration and labeling strategy.
  • Coordinates an optimal IMP distribution strategy to ensure timely delivery to clinical sites.

Project and Stakeholder Management

  • Uses project management techniques to manage effectively and efficiently the set-up of assigned phase 1-4 trials, or the set-up of new capabilities for CTS.
  • Creates and maintains project plans, defining and achieving through the lead of cross-functional teams the planned milestones regarding clinical supply set-up activities including packaging, labeling, distribution, Interactive Response Technology (IRT) and other supply systems.
  • Secures optimal transfer of information/knowledge from Clinical Supply Lead, enabling an efficient start of the set-up activities, and guarantees optimal handover of the project to the Clinical Supply Planner, enabling an efficient study conduct.
  • Drives strong partnership with stakeholders (CTS functions, Clinical Team, Global Distribution and Logistics (GDL), QA, IRT vendor), participating in all required meetings as a liaison for CTS during the study set-up. Educates and influences as needed, to ensure optimal incorporation of CTS input into decisions impacting the IMP supply chain. Leads study set-up meetings for the internal CTS/QA/GDL stakeholders, collecting input on packaging/labeling design and timelines, and agreeing on trial project plan.
  • Ensures Clinical Supply Lead visibility on study supply set-up activities for assigned trials, proactively identifying risks and escalating issues.

Study Set-Up

  • Contributes to IRT specification development by defining the requirements for IMP/inventory management. Coordinates and/or participates in User Acceptance Testing.
  • Issues or coordinates availability of supply set-up documents.
  • Ensures timely and cost effective supply availability for study start.

Desired Education, Skills and Experience:

  • Bachelor’s degree or higher in the Life Sciences, Supply Chain Management or related field.
  • Minimum 2 years’ experience in the pharmaceutical/ biotechnology industry performing international clinical supply chain management.
  • Experience interpreting clinical study protocols and developing well-planned, accurately forecasted clinical supply plans/forecasts.
  • Thorough knowledge of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), International Conference on Harmonization (ICH) Guidelines and other applicable global pharmaceutical regulations/guidelines/directives (e.g., labelling and import/export requirements for clinical supplies).
  • Experience with Interactive Voice/Web Response System (IXRS) design, implementation and user testing.
  • Proficiency in Microsoft applications (Word, Excel, PowerPoint, Outlook, etc.) and collaborative platforms (e.g., SharePoint, Skype for Business).
  • Strong organizational and project management skills (certification will definitively be a plus)
  • Ability to establish and meet multiple concurrent priorities, deadlines, strategic department goals and objectives.
  • Demonstrated ability to work independently and with cross-functional and cross-cultural teams, including Clinical Supply Chain, Clinical Operations, Regulatory, Distribution and Quality teams.

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If you wish to apply for this role, please send your CV with a covering note to oli.dimitrov@advregulatory.com or alternatively, to have a confidential discussion about this or other potential roles or career options, call Oli in the London office on +44 (0)20 7801 3388.
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About Advanced

Advanced Search and Selection Ltd has been operating since 2004. We are registered and licensed to recruit through the United Kingdom, mainland Europe and the Americas.
We match professional candidates to the best permanent, contract and interim roles in the market. For more information about the company visit us at www.advregulatory.com


We provide a high level of service because we believe this matters.

Keywords / Key words: Clinical Trials, CT, Clinical Jobs, Jobs in Brussels, Clinical Trial Jobs, CTS, Clinical Trial Manager, CT Jobs, CT Manager, Contract Jobs, Consultant Jobs.

To Apply : Please send a full CV in confidence to cv@advregulatory.com.

Contact Information:

Address:  Head Office
Suite 8 Penhurst House 352-356 Battersea Park Road London
SW11 3BY
England
Tel:  +44 (0)20 7801 3380
Fax:  +44 (0)20 7228 1188
Website:  Visit Our Web Site

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