Clinical Supplies Operations Manager
Clinical Supplies Operations Manager
We are seeking a Supply Operations Manager, located within commutable distance of J&J site in Beerse, Belgium to join our Clinical Supplies Operations business. The Supply Operations Manager will oversee the coordination and scheduling of CAR-T treatment for individual patients, acting as the primary liaison between internal teams (Global Clinical Operations, Clinical Supply Chain, Logistics) and external clinical sites. This role entails managing all aspects of treatment scheduling and serving as the central point of contact for clinical sites, handling inquiries and coordinating technical aspects related to both Clinical Supply Chain and Clinical Operations activities.
Are you ready to join our team? Then read further!
Role & Responsibilities
- Close coordination with GCO team to understand site-based timings for new site initiations, planning and coordination of logistical test runs between Clinical Sites, CCPC & MFG
- Provides site and study level training related to patient onboarding and all aspects of subject scheduling.
- For each patient identified for participation in a clinical trial, coordinates & tracks the patient journey, triaging any issues to appropriate stakeholders between apheresis & IP receipt on site.
- Provides regular updates on patient status & milestones, notifying internal and external stakeholders of any changes to the schedule with assessment of potential impact.
- Provides slot allotment & availability for apheresis to appropriate site personnel and collaborates with them to achieve approved apheresis date in light of Manufacturing and CCPC availability
- Coordinates all Logistics Test Runs as well as any unused IP returns from site(s)
- Comply with applicable Standard Operating Procedures (SOPs).
- Patient Journey Mapping; able to act as SPOC for any scheduling/logistic related activities & triage any product/COC/COI issues to appropriate stakeholders.
