Michael Schmitz

• Perform role of Standards Functional Expert for metadata and codelist elements. • Act as overall submission lead coordinating compilation of high quality submission packages (data, documentation, programs). • Ensure consistent application of processes throughout life of compound by providing oversight of the entire E2E process. • Maintain oversight of life cycle management requests. Prepare and/or coordinate responses to LCM requests.

• Project Manager for the implementation of a Clinical Data Warehouse based on SAS DD 4.5 using Scrum methodology • Development and management of clinical data standards CDISC (CDASH, SDTM, LAB,…) • Lead of the clinical data standardization group • Management of special data categories (e.g. PK/PD) • Provide strategic and operational input related to data management tasks on project and study level

• Quality control of data sets, modeling analysis plans evaluations and reports • Central point of contact regarding PK/PD modeling for external PK/PD vendors • Functional management of pharmacometrics relevant IT environment • Maintenance of compliance with current guidelines and implementation of relevant policies and procedures

• Definition of SAS data set structures • Coordination of programming activities • Oversight of external contracts • Hard and Software support

• Assisting in PK/PD analysis • Creating reports • Creating and maintaining the study file • Audit PK/PD CROs • Oversight PK/PD contracts and corresponding budget

• Development, validation, implementation and maintenance of LIMS • Review and quality control of toxicokinetic reports • Maintenance of analytical instruments • Setting up, reviewing and manage departmental SOPs