Dr. Dietmar Falke

• Overall responsibility for the CRO department . • Continuous improvement of established CRO processes inclusive SOP development. • Management of freelance Co-workers. • Project management of clinical medical device studies from trial design to the generation of the final report, including submission to Authorities as well as Ethics committees

Scientific input into product profile, communication strategy, presentations and publications Preparation of internal and external presentations and publications. Contact person regarding medical/scientific aspects for investigators, key opinion leaders, in-house departments and co-development or licensing partners. Liaison between clinical development and marketing.

Strategic alignment on study concepts within the organization (including Marketing/Market Access). Project lead/management of international Phase IIIb/VI trials. Data interpretation for posters, papers, and congresses. Planning and execution of advisory board. Management of KOLs. Collaboration on communication strategies and promotional/marketing materials. Review of and content contributions to clinical sections of pricing & reimbursement and submission dossiers. Drug approval process support.

Management of clinical trials in Germany. Submission of clinical trial applications to ethic committees and prepared response documents. Set up and finalization investigator/site contracts and prepared contracts with freelance CRAs Supervision of freelance CRAs.

Investigator recruitment for international studies. Review of study protocols and preparation of protocol amendments. EC and RA clinical trial applications and preparation of response documents. Review of CRFs and other study data

Eberhard Karls Universität Tübingen