Our Clinical Data Managers support our Clinical Data Management department according to Standard Operating Procedures (SOPs) of GCP-Service or Sponsor, ICH/GCP Guidelines and the national laws and regulations. In this role, you will provide comprehensive data management support for all relevant fields. In this international business.

The successful candidate will manage the delivery of high quality data from project start-up and planning to project execution and project closeout on several projects.
You will independently perform project specific quality control and quality assurance tasks on all projects responsible for, as well as other projects, when requested.

Duties and Responsibilities:

• Ensure consistency, accuracy, and adherence to federal regulations, Good Clinical Practice, Good Clinical Data Management Practices, as well as SOPs and Working Instructions.
• Manage patient protocol information and review protocol and incorporate protocol-specific guidelines into the review of clinical trial data
• Contribute to the design of the databases and forms, ensuring they meet requirements for the entry and reporting of clinical data of varying complexity.
• Test new processes and systems for the management of data in clinical trials.
• Test clinical trial databases and data entry screens assuring compliance with protocol and institutional processes and procedures.
• Process, track, and validate data accurately and on time, in accordance with data processing and entry instructions:
• Develop and extract patient clinical data reports.
• Identify project specific reports and assist in the development of these reports.
• Prepare, review, and submit clinical data for monitoring.
• Maintain client communication regarding data management project status and review key project questions with clients.

Required Qualifications:

• Master level degree in Biology, Mathematics, Biostatistics, Computer or Health Sciences or relevant specific qualification (e.g. medical documentation) or any equivalent qualification
• Microsoft office product experience
• Organizational, communication and computer skills
• Fluent in English and German, written and spoken

Preferred Experience.

• Ideally experience in data management for clinical trials
• Database management experience (Postgres, MySQL)
• Experience in eCRF programmes and data management systems is desirable
• Programming experience in SQL or SAS

If you are interested, send us your electronic application (with your salary expectations and earliest start date) and your CV to:

Thomas Kissner
GCP-Service International Ltd. & Co.KG
Anne-Conway-Str. 2
28359 Bremen
Germany
Phone: +49 (0) 421 89676612
Fax: +49 (0) 421 4348659
E-mail: tkissner@gcp-service.com