Clinical Data Manager

  • Im Mediapark, 50670 Köln, Germany
  • Full-time

Company Description

Founded in 1997 by two Medical Doctors , Ergomed Plc is dedicated to the development of new drugs to save or improve lives. Operating with a global footprint in over 55 countries, Ergomed has the expertise to manage even the most challenging clinical trials.  Ergomed provides services to over 100 clients in a range of therapy areas but excels in the provision of services for  complex trials in Rare Diseases, Oncology and Neuroscience.

Job Description

We are looking for a clinical data manager with programming skills (SQL/SAS) , to be based in to be based in Koln, remotely from home or one of our global office locations.

  • Provide oversight and coordination of all DM activities in a project.
  • Coordinate the Data Entry Clerks (DEC) and Database Developers (DBD) allocated to a project.
  • Development of Case Report Forms (CRFs) for data collection.
  • Creation, update and filing of project-related documentation (e.g. Data Management plan (DMP), Data Validation Plan (DVP), Data Entry Guideline, Database Specification Document (DBSD), Database Report (DBR)) in the DM TMF.
  • Performing and documenting periodic QC of DM TMF files and follow up on all action items until closure
  • Perform clinical database development, including data entry screen design, testing and validation based on the DBSD.
  • Program, test and validate edit checks.
  • Combine external data with the clinical database in cooperation with the Statistical Programmer.
  • Export data from the clinical database to authorized recipients (e.g. in CDISC SDTM format).
  • Generation of queries based on edit checks or errors and omissions identified during data entry and manual data review to resolve identified problems.
  • Perform database lock and unlock procedures.
  • Provide validated data exports from the EDC system or the clinical database to authorized recipients (e.g. related to SAE Reconciliation and medical coding where applicable).
  • Communication with the sponsor in close cooperation with the PM.
  • Attend meetings with project team and/or client

 

Qualifications

  • Proven experience working within clinical data management and good technical skills (SQL and SAS)
  • Ability to project manage client relationships and ongoing data management projects
  • Experience of EDC systems and design of eCRF’s
  • Able to work in a fast paced environment and manage multiple projects
  • A minimum of a science based Bachelors degree

Additional Information

Why Should You Apply?

  • We offer the chance to work in a growing Clinical data management   team working on a wide range of projects and therapy areas,  and across all phases
  • We offer a friendly professional working environment
  • We offer a competitive salary plus a good benefits package
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