Clinical Trial Supply Manager
Location: Wavre Walloon Brabant
Category: IT - Software IT - Hardware / Networking Information Technology Production / Operation
Posted Date: Dec 14 2021
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.
- 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.
- You will work 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.
- You will be the Clinical Study Team voice within TRD LDP to communicate needs and constraints in terms of logistic supply management & logistic support.
- You will provide input in development of the study protocol and related documents.
- You will 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).
- You will report newly planned studies and new demand in ongoing studies to TRD GMP Production planner to ensure capacity feasibility is done.
- For each study, you will 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.
- You will 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.
- You will 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.
- You will 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.
- You will ensure study milestones are respected by TRD Clinical Supply Operations based on the planning information provided by the Production planner.
- You will act as the single point of contact for review of study timings and to (re)negotiate due dates.
- You will follow up on study KPIs, identify trends and ensure problems are addressed
- You will 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.
- You will 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.
We are looking for professionals with these required skills to achieve our goals:
- 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. Has a very good understanding of the clinical research and clinical trial management, associated regulatory, processes and quality requirements.
- 2 years of experience in regional clinical study leadership and or labelling/pack, warehouse & distribution activities are desirable (field experience)
- Solid experience working in teams with a broad range of cultures, including team leadership
- Strong skills and experience in project management and tools
- Excellent communication and presentation skills
- 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)
- Operational expertise in risk management and contingency planning
- Possesses excellent English language written and verbal communication skills in addition to proven negotiation skills. Knowledge of French is an asset
- Experience of managing business remotely in a matrix network
- Experience in leading various operational meetings
- Experience in warehouse outsourcing and oversight
If you have the following characteristics, it would be a plus:
- 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; 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
- 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
- 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
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we’re making the most significant changes we’ve made to our business in over 20 years.
We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose.
For New GSK, this is to unite science, talent, and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; accountable for impact – with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey.
Join our challenge to get Ahead Together.
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.
Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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