Head of Clinical Operations (m/f/d)

Your duties As Head of Clinical Operations, you take on the overall strategic and operational responsibility for Clinical Operations and drive the further development of our clinical trial processes and systems. Leadership of a powerful team of specialists in Clinical Operations (including experts in clinical trial support systems, document archiving, and SOP development and management) Ensuring compliance with regulatory requirements for clinical trials of phases I–III and non-interventional studies, and compliance with ICH GCP guidelines Implementation and development of SOPs, other process documents and supporting IT systems in the field of clinical research Integration of principles of risk-based quality management in clinical research processes Supporting employees in clinical research in the implementation of SOPs Promoting innovation and continuous improvement for processes and systems in clinical research Acquisition of cross-disciplinary tasks in clinical research Supporting the study teams and Quality Assurance in the analysis and monitoring of quality indicators for clinical trials and the derivation of optimization measures Coordination with departments that have process and/or system interfaces for clinical research (e.g. Quality Assurance, Pharmacovigilance, Product Development, Approval, IT) Support for audits and government inspections, and support in implementing the resulting action plans Advising the study teams on issues related to Regulation (EU) 536/2014 and on questions related to CTIS Strategic resource planning and budget responsibility for Clinical Operations

Your qualification Management experience (> 5 years) in the pharmaceutical industry or in a CRO Proven expertise in the implementation of global clinical trials (phase I–III) Deep knowledge of international regulatory requirements and ICH GCP Complete study of natural sciences, medicine or pharmacy or comparable qualification Strategic thinking, coupled with operational implementation strength Designed leadership, communication and decision-making Very good knowledge of German and English in word and writing High self-initiative, organisational strength and team orientation Standing for regular attendance at Headquarter Freiburg

Your advantages New Work, flexible working hours and mobile work Various benefits such as Hansefit, Jobrad, Germanyticket, kindergarten grant and purchase of additional holiday days Comprehensive onboarding and mentoring program Individual training opportunities International and growing family business with short decision-making and financial independence For questions, Sabine Aicher is available via e-mail at personal@drfalkpharma.de or under the phone number 0761 1514-253. We look forward to your application via our online portal.