Clinical Operations Manager Early Clinical Research (m/f/d)

Your duties Organisation and responsible takeover of operational activities for the planning, implementation and monitoring of international clinical trials of Phase I in accordance with the GCP/ICH-GCP guidelines, regulatory requirements (EMA/FDA) and internal SOPs Support in the preparation, review and release of all relevant study documents, including study log/report and documents for the submission of studies in cooperation with external service providers (Europe/USA) Contract negotiation with external service providers (e.g. CROs, central laboratories) as well as the creation, transparency and approval of service provider contracts and test medical/centre contracts Planning and monitoring of the study budget in cooperation with the clinical project manager Risk Management Process support for planned and ongoing studies Leading the study-specific electronic Trial Master Files (Veeva Vault) Takeover IMP Management for Ph1 studies and close cooperation with the pharmaceutical team Sponsor Oversight (including Study Metrics, Review Monitoring Reports) and Ensure that studies are conducted on time, in high quality and compliant Organisation of and participation in meetings cooperation in quality assurance measures (revision of SOPs; Support in preparing audits)

Your qualification Complete vocational training or studies with a focus on the medical, scientific or pharmaceutical sector Multiannual professional experience in pharmaceutical industry in clinical development and project management of clinical trials Knowledge of regulatory requirements for clinical trials Very good knowledge in dealing with office applications Very good knowledge of German and English in word and writing Embossed organizational skills, and pleasure in systematic work Flexibility and loadability Embossed communication capability Own initiative, independent but also team-oriented work

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.