We have a clear commitment: putting best-possible solutions in the hands of medical profes
sionals, enabling them to find the right answer to the challenge they face. Fresenius Kabi is a driver of healthcare for the coming decade. We truly live diversity and value different backgrounds and motivations. Around the world, all of us are committed to our shared endeavor: caring for life.
…+ <- Eysins / International · Permanent · Full-time · As of now Director Clinical Operations (m/f/d) With our corporate philosophy of «caring for life», we are committed to putting essential medicines and technologies in the hands of people who help patients and to finding the best answers to the challenges they face. In the field of biosimilars, we develop products with a focus on autoimmune diseases and oncology. Fresenius Kabi SwissBioSim GmbH is specialized in biosimilar medicines and consists of an experienced team of employees located in the Geneva region of Switzerland. As in all our ranges, Fresenius Kabi is committed to provide high-quality and affordable products for the therapy and care of critically and chronically ill patients. Fresenius Kabi SwissBiosim has also been certified as an Equal Pay Employer. Your assignments Main Tasks: The Director Clinical Operations is responsible and accountable for planning, coordinating, overseeing and conducting complex global clinical trials in one or more therapeutic areas. The Director Clinical Operations collaborates in a global environment, using best practices and knowledge of internal and external business issues to improve processes, standards, and services. The Director Clinical Operations is accountable to plan, drive and monitor program related activities throughout the lifecycle of the project ensuring targets are met according to timelines, budget and quality expectations. Lead (multiple) cross-functional teams and drives oversight of CRO's and vendor management and has in-depth business knowledge and strategic understanding of how cross-functional teams jointly achieve objectives and goals of trial team, utilizing knowledge of the organization, processes, customers and key business drivers to increase effectiveness. Understand the different requirements of agencies related to the clinical packages and plans manages accordingly the different functions (ie CSR, TFLs, ISS etc.). Accountable for inspection readiness. Accountable for CAPAS related to clinical programs within the field of Clinical Operations. Accountable and responsible for the financial planning, budget, accruals, Forecasts. Prepare clinical program updates and/or contribution to them as needed. Support Head Clinical Operations in establishing and monitoring best Clinical Operation Practices. Support Head Clinical Operations with strategic planning for the new FKSBS assets. Act as Line manager to Clinical Operations personnel. Other Tasks: Participe in relevant meetings. Plan and set up cross-functional meetings, meetings with vendors and others as needed. Own and/or contribute to SOP development / reviews. Your profile Qualifications: Advance degree in life sciences (graduate degree), e. g. Biology, Chemistry, Pharmaceuticals preferred or medical background. At least 10 years' experience in clinical research in industry, and at least 5 years in clinical trial management. Strong leadership experience in leading teams. Management competencies (leadership, problem solving and decision making skills). Understanding GxP and global requirements. Strong project management skillsets. Excellent communication skills and ability to manage cross functional teams. Ability to deal with complex situations and drive solution orientated thinking. Fully fluent in English. Excellent team player, ability to work under high pressure and pronounced resiliency. Experience working in an international and cross-functional team. Ability to present and defend the perspective. Experienced in Microsoft Project, Excel, PowerPoint. Apply now Share this job Print this Page Your Contact Elisa Arnaud Fresenius Kabi SwissBioSim GmbH Eysins Ref. number: 55056 At a glance Career level: Professional Experienced Job category: Clinical Trial / Statistics Working condition: Permanent / Full-time Business segment: Fresenius Kabi Location: Eysins / International Closing date for application: none - We are looking forward to your application More information Information about the application process Our offer at a glance Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. Our products and services are used to help care for critically and chronically ill patients. fresenius-kabi.com We welcome diversity At Fresenius all job applicants are welcome - regardless of gender, age, origin, nationality, religion, disability, sexual identity and orientation, or any other personal characteristics. All terms used in this job advertisement to denote persons refer to all genders equally (male, female, diverse). All references to persons in this job advertisement apply equally to all genders (male, female, diverse). #careerswithapurpose at Fresenius Over 300,000 people across the globe work at Fresenius to provide better ever medicine for ever more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career - and to become part of our impressive growth story. Fresenius Kabi SwissBioSim GmbH https://files.relaxx.center/kcenter-google-postings/kc-18740/logo_google_kabi.png 2023-03-31T09:22:16.590Z FULL_TIME EUR YEAR null 2023-01-30 Eysins 1262 46.381576 6.2088848