Clinical Data Manager

About the role

PSI, a Contract Research Organization with 30 years of experience in the pharmaceutical industry, is hiring a Clinical Data Manager in Belgrade. The role is central to the clinical research project and suits someone who is detail-oriented, committed to quality and able to handle large volumes of clinical or medical data.

Key responsibilities

• Track database setup, testing, maintenance and data entry
• Communicate with clients, project teams and vendors on data management matters
• Review study documents and design and develop project-specific guidelines and instructions
• Design eCRF, Data Management and Data Validation Plans and test EDC databases
• Ensure data entry, follow-up and validation, including manual CRF review and SAE reconciliation
• Code medical data
• Track and report metrics leading to database lock
• Coordinate processing, dispatch and archiving of CRFs and queries
• Maintain Clinical Data Management working files
• Perform database QC checks, prepare and attend audits
• Train site staff and project teams on CRF completion and data management

Required profile

• College or university degree (a Life Science or Pharmacy degree is a plus)
• Demonstrated experience managing clinical or medical data
• Full working proficiency in English
• Organisational and time management skills, ability to work independently and multi-task

Required skills

• Clinical Data Management systems such as Medidata Rave or Oracle InForm
• MS Office applications