Advanced Group

Clinical Data Manager

3+ months agoKyiv, Ukraine

The Clinical Data Manager is responsible for overseeing all data management activities for assigned projects in accordance with local gudiance and other relevant procedures and guidelines to ensure that a quality work product is produced and timelines and deliverables are met.

  • Participate as the primary data management/lead data manager on multidisciplinary project teams and ensure effective communication exchange
  • Participate in protocol development and review; participate in review of clinical study reports and statistical analysis plans, as required
  • Review and provide input to CRF design and 'CRF Completion Instructions'
  • Develop test scripts and perform user acceptance testing and validation of the database used to collect the clinical data to ensure that they meet requirements for the entry and reporting of clinical data
  • Perform training for appropriate users of the clinical data management system, as required.
  • Produce ad-hoc or standard listings of data from the clinical data management system using the reporting tools provided, as required.
  • Contribute to the ongoing development, review and revisions of data management Standard Operating Procedures (SOPs)
  • For outsourced studies:
  • Manage and collaborate with the Clinical Research Organization (CRO) project team to ensure that study deliverables and timelines are met and to act as the primary point of contact for data management interactions with the CRO.
  • Participate in the development of proposal specifications, review CRO proposals and budgets and assist in the selection of CROs for outsourced work.
  • Monitor the quality of Data Management processes, data and CRO performance.
  • Bachelor's degree OR certification in a related allied health profession from an appropriately accredited institution
  • Minimum of 5 years of data management experience.
  • Project management experience is required. Experience as a lead data manager on multiple studies.
  • Work history at a Clinical Research Organization (CRO) or CRO management experience in data management is required.
  • Oncology, endocrine and/or inflammatory therapeutic area experience is preferred.

Job ID: A_RPO-15490