(Senior) Clinical Data Manager (m/f)

Bavaria | Permanent employment with our customer
Reference number
369273/3
My duties
  • Provide clinical data management support to the clinical trial teams (CTT)
  • Participate in the review of the clinical trial documents (e.g. protocols, case report forms and statistical analysis)
  • Oversee the development and implementation of clinical data management activities outsourced to the vendor in a clinical trial (i.e. Data Management Plan, eCRF, Database Specification, etc.) to ensure quality and adherence to timelines
  • Participate in meetings with vendors to review project plans and timelines, address and resolve issues identified in the trial and requests from the CTT
  • Coordinate the UAT of eCRF build and validation documents including but not limited to edit check document, issue logs, UAT summary report with the vendor
  • Participate in the definition and implementation of eCRF standards
  • Ensure reconciling of SAE data in Safety Database and Clinical Database by the vendor
  • Ensure clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock
My qualifications
  • Successfully completed professional training (Master´s degree or equivalent) in the field of data management
  • Very good practical experience in data management and/or related work experience in pharmaceutical industry
  • Experience with EDC systems like ORACLE. InForm or Medidata Rave
  • Experiences with other data management relevant systems, such as IVR systems and CDMS
  • Knowledge of CDISC / CDASH / SDTM standards
  • SAS and “R” programming experience
  • Ability to coordinate data management activities with external vendors
  • Good understanding of global clinical trial practices, procedures and methodologies (such as ICH-GCP and 21 CFR part 11)
  • Experience in database decommissioning and archiving process
  • Excellent organizational and time management skills
  • Team player with well-developed interpersonal abilities
My benefits
  • Contribution to the strategic direction of drug development
  • Involvement in registration studies and submission activities
  • Design of modern early phase trials
  • Creative work in in cross-functional teams
  • Flexibility in working hours
About Hays
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
My contact at Hays

My contact person
Ann-Kathrin Flöper

Reference number
369273/3

Contact
E-Mail: ann-kathrin.floeper@hays.de