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(Senior) Clinical Data Manager

Grünenthal Group

Aachen, Germany

Purpose of the role:

The (Senior) Clinical Data Manager is responsible for the setup, conduct and close-out of all data management activities in Grunenthal’s clinical trials. The position holder ensures that clinical trial data are collected and reviewed for correctness, integrity & consistency in a timely manner.

Your responsibilities:

  • Implementation of Data management activities within assigned clinical trials;
  • Providing input into the selection and qualification of third party vendors;
  • Manage Data Management CRO and external providers in preparing, conducting and closing of data management activities (e.g. design of Case Report Forms (eCRFs), patient diaries (ePRO), Data Management Plan, database structure and consistency check specifications, data review, SAE reconciliation, coding, database lock);
  • Define (quality) requirements for activities performed by Data Management CRO's or external data providers (e.g. for ePRO data, laboratory data) and provide adequate sponsor oversight;
  • Monitoring and supervision of the set-up and maintenance of CDMS systems and eTools such as EDC & ePRO;
  • Creation and execution of data quality checks and centralized monitoring checks;
  • Filing and archiving of trial documentation;
  • Ensuring that all functional activities are performed to meet the defined timelines, budget and quality specifications;
  • Ensuring compliance according to GCP-ICH and other relevant guidelines;
  • Support of the creation, review and approval of procedural documents for the Clinical Data Management area;
  • Contribution to the further development of the Data Management department.

Your profile:

  • Bachelor’s degree or diploma in data sciences, natural sciences, informatics or equivalent degree;
  • Proficiency and profound experience in all relevant clinical data management activities in the pharmaceutical industry or CRO industry;
  • Experience in leading CDM activities on trial level and managing and supervising external CROs/vendors;
  • Experienced user of CDMS systems and eTools like EDC (Medidata Rave) and ePRO;
  • Strong understanding of data and database structures (CDISC SDTM);
  • Experience in working with SAS and J-Review;
  • Proven ability to work in cross functional teams;
  • Being familiar with all relevant guidelines and aspects of clinical data management;
  • Pro-active and self-motivated personality and flexible but persistent and result-oriented;
  • Excellent communication skills;
  • Proficient verbal and written skills in English.

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