Salvinia Mletzko

> Over 10 years of clinical trials experience in the pharmaceutical, medical device, digital therapeutics, and IVDR field (Research Institutions, Sponsors, CROs) across a wide range of therapeutic areas.
> Profound knowledge of regulatory requirements like GDPR, ICH-GCP, EUR-Lex. 536/2014, EUR-Lex. 2017/745.
> Excellent organizational skills with outstanding prioritizing capabilities.
> Previously held a Research Associate Position at Imperial College, London, UK leading clinical research projects.
> Qualification: PhD, Experimental Immunology, University of London, UK and BSc/MSc Biochemsitry, University of Kiel, Germany.
> Providing operational leadership within RQM+ Europe’s project management team.
> Passionate about delivering effective and efficient service with integrity and accountability using both proven and innovative methods.
> Keen to coordinate individual solutions to fulfil the needs of customers and their product.

As Associate Director of Project Management Salvinia is responsible for the successful planning, implementation, and execution of contracted clinical research activities. Providing operational leadership within RQM+ Europe’s project management team. Salvinia assures clear client and internal team communication for team members, process documentation, and compliance with Good Clinical Practices and procedures set forth by RQM+ and its clients. The Project Management Team is responsible for trials conducted within the CRO services division and is the main interface between CRO and client. The Clinical Project Manager (CPM) works cross-functionally with Clinical Data Management (CDM), Regulatory Services, Clinical Operations (CO), Budget/Contracts, and Clinical Monitoring to ensure that studies are conducted on time, within budget and according to EMA regulations and ICH-GCP. Performs duties in accordance with company’s values, policies, and procedures.