The CTSM is the CI 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 the initiation of a draft concept protocol until the product delivery to the final depot.
Ensure effective interface between CSC and Clinical Study Team including the Study Delivery Lead, Local Delivery Lead, Label expert, pack-expert, depot and Distribution expert and their related quality partners.
Be the Clinical Study Team voice within CSC 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.
Report newly planned studies and new demand in ongoing studies to planning team.
Define the operational set-up in order to align flows, operational strategies and activities (label creation, label/pack warehouse & distribution).
Own the supply chain processes and documents.
Ensure that all study related activities are operationally set-up and conducted in CSC in line with the study team.
Manage and set-up the collaboration with the world-wide depots selected for the clinical study.
Ensure study milestones are respected by Clinical Supply Operations based on the planning information provided by the Production planner.
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.
Requirements
Bachelor's degree in a relevant field, such as pharmacy, life sciences, or supply chain management.
Proven experience in clinical supplies project management within the pharmaceutical or biotech industry.
Strong understanding of regulatory requirements related to clinical trial supply management.
Excellent organizational and communication skills, with the ability to guide cross-functional teams and drive project success.
Problem-solving mindset, with the ability to adapt to changing project dynamics and implement effective solutions.
Benefits
Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.