Clinical Data Manager

☞ AIXIAL GROUP

看过: 145

更新日: 16-11-2025

位置: Charleroi Hainaut

类别: R & D 咨询/客户服务

行业: Pharmaceutical Manufacturing

水平: Mid-Senior level

工作类型: Full-time

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工作内容

AIXIAL is an International Contract Research Organization (CRO),a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV) and non-interventional studies. Our offices are located in France, Belgium, Switzerland, Germany, Denmark, Sweden and Czech Republic.

Due to fast growth of our company, we are currently recruiting a colleague for the position of Clinical Data Manager, who will be responsible for the oversight and the conduct of data management activities for one compound.

The activities include (but are not limited to):

  • Perform the oversight of outsourced studies from start-up to database-lock: define priorities, attend project meetings, set timelines, monitor performance, pro-actively identify risks, escalate issues, and collaborate to the mitigation strategies.
  • Ensure that all tasks defined in the several DM study plans are carried out on time within quality requirements.
  • Participate in the development and the review of all DM study documents: data management plan, eCRF, eCRF Completion Guidelines, edit check specifications, data review listing specifications, data transfer specifications, (SDTM) database specifications, database lock reports.
  • Perform User Acceptance Testing.
  • Participate in trainings for Investigator/Monitor meetings and Site Initiation Visits.
  • Collaborate in the data cleaning processes (Data Review, Data reconciliation, Query management, Patient Profiles review).
  • Ensure that external data are properly reconciled and adequately integrated in the database.
  • Design and review ad-hoc reports to support data analyses, data dissemination, reports to authorities or external partners.
  • Optimize SOPs and attend internal and external audits.

What are we looking for in a candidate?

  • Master’s degree in Biomedical or Pharmaceutical Sciences, Bio-engineering, Biology, Mathematics, Computer Sciences, or related areas.
  • Experience of minimum 5 years of Clinical Data Management.
  • In-depth knowledge of Clinical Data Management processes and systems (EDC, IRT).
  • Knowledge of data management programming software (e.g., SAS, R) is an asset.
  • In-depth knowledge of industry standards (ICH guideline for GCP, CDASH, SDTM).
  • Experience with external data management (safety, labs, PK, PD, biomarker, etc.).
  • Strong organizational and analytical skills. High attention to detail.
  • Able to work within a team, on simultaneous projects, and with minimal supervision.
  • Strong negotiation, communication, decision-making, and problem-solving skills.

Does this sound exciting to you? If so, we look forward to meeting you!

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最后期限: 31-12-2025

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