Karlheinz Pulzer

- International manager in clinical data management - responsible for 20+ people incl. managers in Germany, US and Hungary - People and talent management (remote, hybrid and office) - Work organization, hiring, training and mentoring (+organization), strategy management, budget and resource planning, process development and control (by KPIs and metrics), escalation management - Leading different meetings on team and manager level - also cross-functional - Audits (clients and agencies (FDA, TÜV, etc.))

- Primary contact for a key account for all Data Management related issues - Developing and implementing data management process standards with the key account - Management of an internal functional customer Data Management Team - First escalation level for the internal functional customer Data Management Team - Mentoring and senior support for other Data Managers - Planning and conduct of training for Data Management team members and members of other departments - incl. all activities of a Data Manager

- Creation of specifications (e.g. Data Management Plan, Data Transfer Specification) - Define customer standards and advise customers on data transfers, data structure, data formats - Regular delivery of data transfers to the customers – in ASCII or SAS (sas7bdat or .xpt) files using CDISC (SDTM) standards among others - Conversion of ASCII files to SAS (.sas7bdat or .xpt) - Creation and automated execution of edit and data quality checks (for e.g. duplicates, ranges, etc.) with MS Access and SQL