About the role

The CTSM is the TRD LDP single point of contact for the study team (Central & LOC’s).

The CTSM is accountable for the set-up and follow-up of the logistical activities from issue of a draft concept protocol till the overall vaccine reconciliation at study end.

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 (Central and Local) to support the delivery of clinical vaccines and ancillaries in time at right quality and within agreed budget

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.

About the responsibilities

• For a project or a group of studies covering different projects, ensure effective interface between TRD LDP and Clinical Study Team including the Study Delivery Lead, Local Delivery Lead, Label expert, pack-expert, depot and Distribution expert and their related 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 TRD LDP 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 (PFM).
• Report newly planned studies and new demand in ongoing studies to TRD 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 TRD 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 vaccine 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 TRD 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 CTSMs.
• 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.

About you

• University scientific degree or equivalent background (Master in Logistics, Biomedical Sciences, pharmacy, Chemistry, Bio-Engineer, Project Management)
• 6 years of significant experience in managing clinical research studies and logistic operations or equivalent.
• 2 years of experience in regional clinical study leadership and or labelling/pack, warehouse & distribution activities are desirable
• 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 
• Demonstrates an 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)
• Able to lead and work within teams and networks across functional and geographical boundaries; leads by example and promotes collaboration, effective communication and leadership in others
• Able to set and manage priorities, performance targets and project initiatives in a global environment
• Operational expertise in risk management and contingency planning
• Applies industry best practices to the design and execution of supplies for clinical studies to improve time and cost efficiency
• Acts as role model in line with GSK Vaccines core values and Expectations
• Demonstrates analytical and strategic thinking
• Effective at problem solving and conflict resolution
• Possesses excellent English language written and verbal communication skills in addition to proven negotiation skills. Knowledge of French is an asset
• In-country CRA / monitoring/ sites experience is an asset
• Good helicopter view especially to proactively detect problems and define possible solution and/or to surface issues to Management
• Experience of managing business remotely in a matrix network
• Experience in leading various operational meetings
• Experience in warehouse outsourcing and oversight

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If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

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