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Clinical Data Manager - Oversight - Optimus Search - HELP

Clinical Data Manager
CRO Oversight
12 Month Contract
70-90CHF/hr
Geneva, Switzerland

Optimus Life Sciences are working with a Swiss-based biopharmaceutical company, they are looking for a contract CDM to be based near Geneva, Switzerland.

The role will be working with Phase III Oncology Trials and focused on the oversight and management of the CROs responsible for the outsourced work.

Responsibilities

  • Define and manage Clinical Data Management timelines on multiple studies or programs for the responsible CROs.
  • Prepare data management plans, data validation plans and other study-specific procedures and guidelines in compliance with standard processes and SOPs.
  • Coordinate CDM activities for assigned studies/programs, including eCRF design, EDC system set up, user acceptance testing, users training, database release, data review, and query generation and data coding.
  • Make sure of appropriate study-specific training is provided to assigned study teams and documented.
  • Ensure ongoing and timely data capture and data cleaning, including external data sources.
  • Lock, transfer, and archive databases.
  • Deliver/coordinate data management support to study teams to support timely and ongoing data review and monitoring.
  • Ensure study timelines are met and data quality is according to high industry standards.
  • Ensure adherence to GCP, regulatory guidelines, standard processes, and SOPs.

Requirements

  • Degree level education.
  • 5 years' experience in a clinical data management.
  • Experience using major EDC systems (Medidata RAVE) and related tools and technologies.
  • Prior experience leading data management studies, delivering quality databases that meet regulatory requirements.
  • Fluent in English language.
  • German or French language skills are a bonus.

If you think this would be an interesting opportunity for you, and you're able to start contracting please send a CV to (see below)