Clinical Data Specialist
vor 21 Stunden
**Welcome to our sector Life Sciences.** Around 3,000 colleagues worldwide make their contribution to the most important thing in life: health. From the development of vaccines and the digitalisation of the health care system to forward-looking topics such as eHealth and digital therapeutics, we place our expertise in the pharmaceutical sector, medical technology and biotechnology at the service of our renowned customers. Are you the one to explore **LIFE**?
**THIS IS WHAT WE OFFER**
- Exciting mix of projects in R&D and Digital Manufacturing, high learning effects as well as varied fields of activity from the world of Capgemini Engineering for the most renowned clients in Biopharma, MedTech and Consumer Health.
- High transparency in career development in an extremely dynamic work environment, where promotion opportunities and perspective have a great deal of scope.
- Appreciative, diverse work environment, individually tailored training opportunities, web-based training platform with internal and external training opportunities.
- Numerous networking opportunities via professional and technical communities, but also celebrating across locations is part of our culture (e. g. team events, summer party, kick-off events etc.).
**THIS IS THE JOB**
- You are responsible for overseeing and tracking clinical data management tasks to ensure that they are performed in accordance with the study protocol, standard operating procedures, and regulatory guidelines.
- You develop and maintain study-specific data management plans, which include creating data collection forms and data transfer agreements.
- You review and validate clinical trial data to ensure that it is complete, accurate, and consistent by utilizing industry-standard tools and procedures.
- You ensure that data management is in compliance with regulatory guidelines and industry standards, including SDTM and ADaM.
- You communicate with cross-interface contacts (medicine, laboratory, biology etc.) to understand their requirements and to showcase your developed solution.
**THIS IS WHAT WE NEED**
- Master degree in bioinformatics, computer science, computational biology, or comparable qualification.
- At least 4 years working / research experience in data management within the pharmaceutical or biotechnology sector.
- Profound knowledge of GxP-regulated clinical research, processes in clinical data management principles, CDISC standards, SDTM, and general clinical trial processes.
- Familiarity with FDA and EMA regulations.
- Good knowledge of statistical software such as R and SAS.
- Ability to work in multinational teams and have a client-facing role.
- Strong analytical thinking, above-average comprehension skills, independent problem-solving ability.
- Reliability, strong communication skills and strong team play.
- Business fluent in English and very good presentation and communication skills, German language skills are advantageous.
**WE LOOK FORWARD TO MEETING YOU**
Do you have any questions about the job profile and/or requirements?
Please get in touch with your contact person in Recruiting.
Capgemini Engineering
Altran Deutschland S.A.S. & Co. KG
**Asaja Köppermann**
+49 1748349917
- Capgemini Engineering is committed to the employment of a diverse workforce. Qualified applicants are considered regardless of their origin, skin colour, religion, gender, age, sexual orientation, gender identity, gender expression, veteran status or disability._
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