Clinical Trial Supply Manager

Over 15 years of experience in Clinical Supply and Logistics, supporting global clinical programs across all study phases (Phase I–IV)

Comprehensive expertise covering the end-to-end clinical supply chain, including procurement, outsourcing, budgeting, inventory management, packaging, labeling, quality oversight, distribution, and IVRS/IWRS processes

Hands-on experience with Cell & Gene Therapy products, managing complex supply chains and temperature-sensitive materials

Excellent feedback from the current project in complex IMP project (import to US)

Providing hands-on consultancy for a biotech company in Belgium

Forecast, plan, coordinate and execute clinical trial supplies at the protocol level for Phase 1-4, ensuring timely availability of investigational drug supplies and related services (pharmacy manual, investigator training materials, UAT, TMF filing and audit preparations) for multiple clients

Review manufacturing and packaging records to ensure compliance with GxP, develop SOPs and enhance CTS processes

Highlights of expertise include Drug Development Procedures, Strategic Business Planning and Implementation, Supply Chain Activities, Contract Management, Risk Analysis and Assessment, Clinical Demand and Supply, Vendor Management, Leading clinical supplies status meetings, Advisory and Consultation

Coordinate international logistics of IMPs, its precursors (e.g. unlabeled finished product), test samples and reference samples, ensuring timely and compliant delivery to project stakeholders, including CMOs, storage providers, test laboratories, clinical sites 

Manage import/export processes between EU countries and the US, including country-specific regulatory requirements

Prepare and submit documentation for import permits, CDC permits, and customs clearance

Ensure compliance with IATA regulations for the transport of dangerous goods, including infectious and genetically modified substances

Maintain oversight of temperature-controlled shipments and chain-of-custody documentation

Collaborate with CROs, sponsors, and regulatory authorities to resolve logistical and regulatory challenges

Assisted small and large pharmaceutical companies (Sponsors) with execution of clinical trials

Managed all aspects of supply chain including creating labels, overseeing vendor activities, providing IRT support, and resolving IP issues

Performed batch release/review of IP

Created Investigator training presentations, pharmacy manuals, CTSM plans

Successfully resolved multiple incompliance issues on projects through quality assurance experience.

Effectively managed group’s inbox and assigned work to members

Advised an EU-based team and delivered consultancy services on all clinical trial supply activities for peanut allergy and food challenge clinical studies

Acted as the focal point of contact for all drug supply challenges

Coordinated with stakeholders across all areas of the business; used business analysis techniques to identify, analyse, and document business needs

Contributed to internal and external communication plans

Created flowcharts, diagrams, and presentations

Mentored and trained stakeholders on clinical supplies procedures

Defined roles and responsibilities of the Clinical Supplies Manager and served as the sole clinical supplies expert in the EU

Suggested various procedures that were later implemented

Resolved issues and complaints by engaging with clinical team members and CRAs

Generated initial and revised drug forecast at study and program level, communicated demand requirements to CMC and significant stakeholders

Directed overall aspects of TMF filing process and coordinated required documentation and activities for import and export of clinical supplies

Collaborated with global clinical teams, IRT, clinical science, and in-licensing partners and led drug supply material planning on program level