Adèle Broxtermann

Clinical Study Contract Management

Clinical Budget Management for Non US countries (50 countries), phase I-III studies, Training Affiliates, preparation of Clinical Budgets and Negotiation Parameter for clinical studies, Checking and approving study payments, Online FAQ sessions to budget negotiations, Updating country specific requirements for FMV Payments, Analysing FMV Standards Cooperation with internal legal department, compliance and clinical Team. Mapping/Analysing process workstreams

Contract negotiation with clinical sites and lawyers, updating contract language, contract amendments, Payments (preparation, checking, tracking and clearing invoices), Study budget management (phase I-III, DACH studies), CRO/Phase 1 specialist for contracts and study budgets, Financial Audits, International and internal Kaizens (process analysis, simplification of an actual process), Implementation of a new process (checklist, guidance documents and excel tools), Mentoring colleagues,