Clinical Data Manager (w/m/d)

Profile is an internationally active and renowned contract research institute in the field of metabolic diseases founded in 1999. We have been working with the pharmaceutical industry for many years to develop new medicines for the treatment of diabetes, and obesity related diseases. We also strongly support the further development of known active ingredients and the technical possibilities for administering insulin and measuring the blood sugar concentration. Due to our years of experience, we have been able to develop comprehensive scientific know-how and unique expertise in the field of metabolic diseases. We are currently employing approx. 400 employees who make an important contribution to improving the quality of life of people with diabetes. We are looking for a*n Clinical Data Manager (w/m/d) – full-time –

In your role as Clinical Data Manager, you will ensure the correct, complete and regular collection and preparation of the study data for the statistical analysis in Phase I and Phase II studies. Your core tasks include: Project responsibility and close cooperation with study teams, monitoring, statistics, laboratories and international sponsors Creation of all necessary data management documents, including Data Management Plans (DMP), eCRFs, Annotations and Trial Validation Plans (TVP) Structure and maintenance of study databases and integration of external datasets Monitoring data quality including query management and programming of Edit Checks (e.g. in SQL) Planning and coordination of the Database Lock Use and co-development of In-House created customized software

You will have completed your studies in medical documentation, medical informatics, digital health management, health care management or a natural science course with corresponding further education. You have first knowledge in the field of study design, study protocols, GCP (Good Clinical Practice) and the relevant regulatory requirements (ICH-GCP, 21 CFR Part 11) Experience in handling eCRF systems as well as knowledge in data validation, edit check creation, query management and processing of external data sources (Labore, ePRO/eCOA etc.) Secure handling of Excel, databases and ideally SQL as well as a good understanding of data structures, terminologies and coding systems (e.g. MedDRA, WHO-DD) Basic knowledge of programming or query languages is advantageous Analytical thinking, structured working and a high degree of accuracy Communication and team skills as well as good English skills in word and writing complete your profile

A very good working environment in a motivated team Interesting activity at the interface of pharmaceutical industry and academic world. Green and practical integration A highly trusted and collegial culture Attractive remuneration with annual inflation compensation Bicycle leasing (also e-bikes) via BusinessBike incl. free charging Corporate Benefits: Exclusive employee discounts at over 800 providers Grant for lunch in our cafeteria EAP staff support program for professional short-term advice on health, professional and personal issues as well as the placement of specialist appointments