Proclinical is seeking a Global Trial Supply Manager to support clinical supply chain operations for global clinical studies in the oncology and pharmaceutical sectors. This role involves creating and maintaining supply strategies for investigational products, ensuring timely delivery of quality clinical supplies, and collaborating with cross-functional teams to meet study and corporate goals.
Key Responsibilities
* Develop and maintain clinical supply chain strategies aligned with study and corporate objectives.
* Collaborate with internal teams and external service providers to ensure all supply needs are met.
* Review clinical protocols and provide input on timelines and investigational product strategies.
* Create supply forecasts based on clinical development plans and monitor inventory and drug utilization.
* Issue manufacturing and packaging/labeling requests in alignment with master planning timelines.
* Monitor investigational drug use dates and support use date extension activities.
* Ensure compliance with regulatory and quality requirements for clinical supplies.
* Participate in the development and review of Interactive Response Technology (IRT) specifications.
* Manage investigational product distribution strategies at depot and site levels.
* Act as the primary contact for clinical supplies for assigned compounds and studies.
* Support inspection readiness activities and prepare necessary documentation.
* Address product complaints, deviations, and change controls in collaboration with relevant teams.
* Contribute to departmental procedural document writing and continuous improvement initiatives.
Key Skills & Requirements
* 2-3+ years experience leading end-to-end clinical trial supply strategy + operations
* Strong knowledge of global drug development processes and regulatory requirements.
* Proficiency in forecasting, planning, and project management.
* Experience with clinical supplies, including manufacturing, packaging, labeling, and logistics.
* Familiarity with IVRS, CTMS systems, and import/export requirements.
* excellent communication, negotiation, and conflict resolution skills.
* Ability to build consensus, influence stakeholders, and lead cross-functional teams.
* Analytical mindset with a results-driven approach.
* Experience in coaching, mentoring, and fostering teamwork.