Team Lead (m/w/d) Lab Data Management

Profil is an internationally active and renowned contract research organization (CRO) specializing in metabolic diseases, founded in 1999. For many years, we have collaborated with the pharmaceutical industry on the development of new drugs for the treatment of diabetes, obesity, and related conditions. We also provide intensive support for the further development of existing active ingredients and the technological advancements in insulin delivery and blood glucose monitoring. Our extensive experience has enabled us to build comprehensive scientific know-how and unique expertise in the field of metabolic diseases. At our headquarters in Neuss, we currently employ approximately 400 people who make a significant contribution to improving the quality of life for people with diabetes.

We are looking to fill the following position as soon as possible:

Your tasks:

• Professional and disciplinary management of the Lab Data Management Team (in Germany and possibly other locations); resource planning and task allocation for international projects.
• Conducting employee interviews and skills development in the Lab-DM team
• Development, enhancement (including automation) and monitoring of standardized and GCP- & CDISC-compliant lab-DM processes across projects and branches.
• Overall monitoring of project progress, risks and resources
• Ensuring consistently high data quality (device and laboratory data) and intervening in case of quality or deadline risks.
• Coordination and alignment with interfaces (e.g. statistics, SDTM/CDM, laboratories, CRU etc.) for overarching topics
• Participation in audits and inspections; maintenance of metadata and lab DM SOPs.
• Effort estimation for proposal/budget preparation for lab-DM tasks

Requirements:

• You have a degree in a natural science field.
• Several years of professional experience in clinical data management, ideally with knowledge of early study phases (Phase 1/2) and regulated environments (GCP, ICH, etc.) as well as in the processing and quality assurance of device and laboratory data.
• Leadership responsibility with a focus on the continuous development of your team and processes.
• Overall process and decision-making responsibility for ICG-GCP and CDISC-compliant data structures and standards, as well as maintenance of sponsor standards and automation in lab data management.
• Planning, delegation and decision-making authority – You have project-wide responsibility for timely and accurate device and laboratory data and decision-making responsibility for lab data methodology and processes.
• Enthusiasm for the application of new technologies and continuous review of the application possibilities of these technologies, for example AI / Responsibility for the digitization of Lab DM processes Excellent written and spoken German and English skills, as well as experience in an international work environment

We offer:

• A responsible leadership role in an international, scientifically oriented and dynamic environment
• A collegial team with commitment, competence and team spirit
• Structured onboarding as well as room for personal responsibility and innovation
• Flexible working conditions with short decision-making processes
• A corporate culture characterized by trust, transparency and openness
• Attractive salary with annual inflation adjustment
• Bicycle leasing (including e-bikes) via BusinessBike including free charging facilities
• Corporate Benefits: Exclusive employee discounts at over 800 providers
• Subsidy for lunch in our cafeteria
• Employee Assistance Program (EAP) for professional short-term counselling on health, professional and personal issues, as well as arranging appointments with specialists.

Have we sparked your interest? Then we look forward to receiving your application, including your earliest possible start date, by email – preferably as a PDF – to the following address: hr@profil.com

Profil Institute for Metabolic Research GmbH

Tim Gottschalk,
Executive Director Human Resources,
Hellersbergstraße 9,
41460 Neuss,
www.profil.com