My key areas of responsibility:• Manage IRT set up for the supply chain part of the study• Lead and provide direction to Study Drug Working Groups, comprising members of Supply Chain, Clinical Development and external partners • Ensure deliver of drug supply effectively and according to budget, balancing cost and risks with support from cross functional groups • Understand and translate clinical study protocol requirements into demand for drug supply within a clinical study. Author the drug supply section of Clinical Study Protocol and lead development of master label text • Collaborate with CRO partners in development of pack design and review the technical part of the outsourcing contract. Review changes to the contract with CRO partners and Sourcing Managers as necessary • Manage the budget for drug supply activities and materials for the project. Manage change in demand and supply, resolve issues, escalating when appropriate • Work within GMP Quality Management Systems, including managing deviations, complaints, change controls as appropriate• Network representative for supply chain SE in the Global Label Expert Group

My key areas of responsibility:• Leader of the SMM Collaboration Expert Group at the Gothenburg Hub (sponsor Julieta Jimenez, Hub Manager)• Working in the Declare study (phase IIIb trial in the cardiovascular area)Key areas of responsibility in Declare were as follows:o Working group lead for the SMM Collaboration Groupo Part of the IRT Working Groupo Main contact against the vendor Worldwide Clinical Trialso Operational main contact against the CRO TIMI o Country contact against SMM in several countries worldwide

My key areas of responsibility:• Working in a Phase II trial in the urology area and a Phase II trial in the respiratory area• Performing Site Initiation Visits, Monitoring Visits, Support Visits and Site Close-out Visits according to the Monitoring Plan and SOPs• Site management and study administration• Tracking patient recruitment• Assisting in preparation of Ethics Committee amendments• Preparing country and site level IP release packs• Attendance of study related trainings (including SOP and GCP training)• Archiving of study documents in the eTMF• Project handover• Resolve data issues and audit issues

My key areas of responsibility:• Working with a Phase I trial and a Phase II trial in the cardiovascular area.• Manage the central laboratory • Country contact against SMM in several countries in Europe• Co-monitoring• Write study specific documents • Work with the clean file procedure