Clinical Data Manager

Permanent or temporary - - Quality Management in Pharma & Life Sciences

Clinical Data manager

Apply now

  • Data Management Experience
  • Clinical Trial Experience
  • Vendor Oversight

What you'll do

Clinical Data Manager

The CDM is responsible for all clinical data management aspects for the assigned global clinical studies from preparation until archiving. The study responsibilities include:

  • Responsible for leading the CROs data management activities and responsible for overseeing vendors involved in the assigned clinical studies
  • Assisting in Vendor contract negotiations
  • Overseeing and tracking patient data entry and query resolution following agreed timelines
  • Performing QA/QC checks of the data recorded in the clinical database  
  • Ensuring timely collection of CRF documentation for periodic Medical Review and IDMC/DSMB Review
  • Pro-actively identifying and solving issues in the assigned clinical studies and timely escalating them to the Clinical Study Manager, Project Manager, Head of Clinical Operations or Senior Management, if needed

The CDM will also participate in activities other than study-related which included but are not limited to:

  •  Co-writing/maintaining SOPs within the Clinical Operations department related to Data Management
  • Staying up to date with applicable industry standards related to Data Management (ie CDISC, SDTM,…)

Who we're looking for

  • Knowledge of ICH-GCP
  • Experience with tools and systems for managing clinical studies (study progress and metric systems, eCRF databases, CDISC and SDTM)
  • Minimum of 5 years of experience in Clinical Datamanagement
  • Experience in managing CROs and vendors
  • Auto-immune and/or oncology clinical study background is a plus

 

What you'll get

Our Pharma & Life Sciences department is growing. We offer you the opportunity to join our dynamic team of consultants, work on projects that will challenge you, and that will push you towards the next step of your career.

Do you have what it takes? Apply now.

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