Data Manager

Responsibilities

• Track database set-up, testing, maintenance and data entry
• Communicate with clients, project teams and vendors on data management matters
• Review study documents, 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 the processing, dispatch and archiving of CRFs/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 topics

Requirements

• College/University degree in Life Science or Pharmacy
• Demonstrated experience managing clinical or medical data
• Full working proficiency in English
• Experience with Clinical Data Management systems (e.g. Medidata Rave, Oracle InForm)
• Proficiency in MS Office applications
• Strong organizational and time management skills
• Ability to work independently and multi-task

About the Company

PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. A privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries and continents.