Clinical Trial Supply Manager

Clinical Trial Supply Manager

Keyrus Biopharma

Walloon Brabant, Belgium

Job Description

As a Clinical Trial Supply Manager within Keyrus Biopharma, you will join a team on client's site and be is accountable for the set-up and follow-up of the logistical activities from issue of a draft concept protocol till the overall product reconciliation at study end.

Scope:

The scope of work includes project management, leadership, and oversight of both global and in-country activities, as well as authorship of some study documents. This includes:

  • the translation of study protocols into an operational demand;
  • the feasibility assessment for completion of logistical activities;
  • the definition of the logistic operational strategies (supply, distribution, randomization,...);
  • the set-up & follow-up of clinical supply related activities for a project or a group of studies;
  • the guaranty of alignment among the network of stakeholders, GMP operations and clinical operations to support the delivery of products and ancillaries in time at right quality and within agreed budget.

You will coordinate and manage indirectly up to 30 central and local clinical and GMP operational functions and experts involved in the preparation and delivery of the supplies for a study.

Role and main tasks:

  • For a project or a group of studies covering different projects, ensure effective interface between Research & Development department, Clinical Study Team, QA partners, by providing input in study protocol, provide logistic instructions for investigational sites, informing about logistic requirements and due dates, supply issues;
  • Be the Clinical Study Team voice within Research & Development department to communicate needs and constraints in terms of logistic supply management & logistic support;
  • Provide input in development of the study protocol and related documents;
  • Establish operational feasibility of each new study protocol and escalate detected feasibility issues at both Clinical Study team, Clinical Supply Operations and Portfolio Manager;
  • Report newly planned studies and new demand in ongoing studies to GMP Production planner to ensure capacity feasibility is done;
  • For each study, define the operational set-up in order to align flows, operational strategies and activities (label creation, label/pack warehouse & distribution), ensure alignment with the other stakeholder’s constraints and develops study logistical plan and including detailed schedule and budget;
  • Own the supply chain processes and documents. Ensure that all study related activities are operationally set-up and conducted in GMP in line with the approach agreed with the study team;
  • Manage and set-up the collaboration with the world wide depots selected for the clinical study in line with the local requirements defined with the countries involved in the study;
  • Study follow-up and guarantee study continuity by ensuring products re-supplies are done in time according to the recruitment strategy and changing needs of the studies and countries;
  • Ensure study milestones are respected by Clinical Supply Operations based on the planning information provided by the Production planner;
  • Acts as the single point of contact for review of study timings and to (re)negotiate due dates;
  • Follow up on study KPIs, identify trends and ensure problems are addressed;
  • Act as Subject Matter Expert for one or several processes of the team. Ensure standard processes and ways of working are in place across all project and studies for all key activities of Clinical Trial Supply Managers;
  • Develop and maintain the appropriate documentation (SOPs, WIKI, guidance, training material to support operations) related to logistic processes, study management and the interface with other stakeholders.

Profile

Education and Experience:

  • Master in Logistics, Biomedical Sciences, pharmacy, Chemistry, Bio-Engineer, Project Management;
  • Specialization in Project Management (Supply Chain and/or Clinical Operations);
  • Ideally +2 years of experience in regional clinical study leadership and or labelling/pack, warehouse & distribution activities.

Required skills:

  • Good knowledge ICH-GCP and regulatory requirements;
  • Excellent understanding of the clinical study, logistic GMP operations and other associated process and quality requirements, including ICH/GCP guidelines and requirements;
  • Good project management skills (including scope, budget, timeline, and resource planning and management, and use of associated tools and support where available);
  • Competencies in Clinical study management and Project Management;
  • Drug supply (including IVRS) management and GMP experience are preferred;
  • Experience in warehouse outsourcing and oversight is an asset;
  • Fluency in English. French is an asset;
  • Proven negotiation skills;
  • Operational expertise in risk management and contingency planning;
  • Apply industry best practices to the design and execution of supplies for clinical studies to improve time and cost efficiency.

Soft skills:

  • Excellent communication and presentation skills;
  • Solid experience working in teams with a broad range of cultures, including team leadership;
  • Process minded, keeping openness for specific project needs;
  • Strong ability to coach colleagues and to engage them in new ways of working;
  • Excellent leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives;
  • Able to lead and work within teams and networks across functional and geographical boundaries; lead by example and promote collaboration, effective communication and leadership in others;
  • Able to set and manage priorities, performance targets and project initiatives in a global environment;
  • Demonstrate analytical and strategic thinking;
  • Effective at problem solving and conflict resolution.

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© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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