Job Description

　　Cerner Enviza (an Oracle company) is a leading global healthcare consulting firm and trusted advisor to many of the world's top pharmaceutical, biotech, and medical device & diagnostic companies. By supporting the work of Cerner Enviza, you will work with world-class healthcare companies, helping them improve global access to medicines by connecting science and research.

　　With ongoing and ground-breaking developments in Oncology and Rare Disease, an increased focus on more scientific, targeted medicine and continuous integration of technology into development and delivery of medicine, there has never been a more exciting time to work in Life Sciences and, with Cerner Enviza immersed in all of these, there has never been a better time to join us and make a difference to our clients and the lives of patients.

　　KEY OUTCOMES

　　Management, maintenance and coordination of the logistical aspects of clinical trials and non-interventional studies (NIS) according to GCP/GPP and relevant SOPs, supporting the Senior Project Manager

　　Act as contact person for routine study related issues for the Cerner Enviza study team(s) and at Cerner Enviza affiliates, the investigative sites as well as for the sponsor and possible further external suppliers (e.g. central lab, translation services)

　　Act as central project manager for clinical trials and non-interventional studies

　　May act as local project manager for clinical trials and non-interventional studies in European countries (including feasibility, site contracting, remuneration among other tasks)

　　Accountable for achieving successful delivery of services at the project level by meeting company and regulatory requirements, quality/scope, timelines and budget constraints

　　Support set-up and coordination of monitoring-related activities. May act as a Co-Monitor for monitoring activities in European countries

　　Coordinate regulatory and ethical aspects needed for initiating multinational studies globally and if required, perform regulatory and ethical tasks in the European countries

　　Ensure that the conduct of the study complies with the currently approved protocol/amendment(s), GCP/GPP guidelines, and all applicable regulatory requirements

　　Support proposal and budget preparation and preparation of client presentation (e.g. bid defense meeting)

　　Qualifications

　　Bachelor's Degree in Life Sciences, Pharmacy or Public Health or relevant professional education with several of practical experience. An epidemiological background will be highly recognized

　　Clinical project management experience (or similar research experience) with increasing levels of responsibility, ideally within CRO industry. Experience in the pharmaceutical, biotechnology or medical device industry could be beneficent

　　Well experienced in regulatory and ethical requirements for clinical trials and non-interventional studies (NIS) in the DACH countries

　　Thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH

　　Guidelines regarding drug development phases, clinical research and data management methods

　　Experience in late phase/non-interventional research

　　Knowledge of regulatory and ethical approaches in the European countries

　　Excellent verbal and written communication skills in English and German

　　Very good knowledge of MS Office

　　Experience in handling with clients (sponsors)

　　Complete grasp of complex interrelations

　　Careful, precise work and organizational skills

　　Team player and cross-cultural competence

　　Additional Information

　　All employees must be legally authorized to work in the country where the position is located. Work visa sponsorship is not available for this position.

　　Company Overview

　　Cerner is a place where people are encouraged to innovate with confidence and focus on what is important - people's health and the care they receive. We are transforming health care by developing tools and technologies that make it more efficient for care providers and patients to navigate the complexity of our health. From single offices to entire countries, Cerner solutions are licensed at more than 25,000 facilities in over 35 countries.

　　Cerner's policy is to provide equal opportunity to all people without regard to race, color, religion, national origin, ancestry, marital status, veteran status, age, disability, pregnancy, genetic information, citizenship status, sex, sexual orientation, gender identity or any other legally protected category. Cerner is proud to be a drug-free workplace.