Mandy Günther

Design of forms and events for data collection of subjects in clinical trials within EDC sytems. eCRF setup and updates. Configuration of eCRF functionalities. Programming of validation checks (JavaScript)

Development and quality review of database (EDC); Calculations for RfP; Coordinate upcoming tasks during life cycle of clinical study supporting PM; Edit check testing; Review management plan and procedural documents; Training slides for users; Maintain user accounts and management of permissions; Help desk; Review of data discrepancies and resolution; Contact for Data Privacy Officer/client/internal stakeholders;Develop data privacy management, related paper and coordinate actions to ensure GDPR compliance

Self-reliant follow-up on administrative client requests as LeadPA, Organize global CRA trainings and client meetings within given budget, Involved in submission of the clinical trial to Ethics Committees or Regulatory Authorities for approval, Liaise with contract specialists for executing investigator contracts, Keep the CTMS up-to-date, maintain study files and keep them audit-ready, Compilation of essential documents for green light of drug release to investigational sites

In direct contact with clients and follow-up on their requests, Independent collection of missing data for creating extensive reports, Prepare submission of the clinical trial to Ethics Committees or Regulatory Authorities, Organization of investigator payments, Preparation of team meetings, create minutes

Bürowirtschaft, Betriebslehre, Wirtschafts- und Sozialkunde, Informationsverarbeitung, Sekretariats- und Fachaufgaben