Clinical Data Coordinator

• Participate in clinical data management activities for clinical trials undertaken or managed by Indero
• Ensure clinical trial data is collected, managed, and reported clearly, accurately, and securely
• Conduct activities in conformance with regulatory requirements, industry guidelines, Indero SOPs, sponsor requirements, and timelines
• Provide general data management support to the project team, sponsor, and external vendors
• Support the Lead Data Manager with data review, data reconciliation, discrepancy management, study metrics maintenance, and study status monitoring
• Provide data status reports to the project team as needed
• Generate ad-hoc study reports
• Perform user maintenance
• Assist with user acceptance testing
• Assist with database design
• Assist with creating the data management plan and related documentation
• Assist in ensuring data management documentation is complete and up to date in the trial master file

• B.Sc. or related field
• 1 year of clinical data management experience in the pharmaceutical industry or in a CRO environment is considered an asset
• Experience using an EDC system (ie. Medidata Rave, Medrio) is considered an important asset
• Skilled in use of computer technology, and ability to learn new applications
• General knowledge of CDASH/SDTM is considered an asset
• Highly organized and detail-oriented with effective project planning and time management skills
• Strong verbal and written communication skills in English; French is an asset
• Ability to work in a fast-paced environment and prioritize multiple competing demands
• Excellent interpersonal, communication, problem solving and organizational skills
• Ability to work independently and in a team environment
• Understanding of the drug development process and applicable regulations, including Good Clinical Practices, ICH Guidelines, and applicable Health Canada and FDA regulations/guidelines
• Must be legally authorized to work in South Africa
• Attendance at some meetings outside regular business hours, primarily in the evening

• Flexible work schedule
• Permanent full-time position
• Ongoing learning and development
• Attractive advancement opportunities
• Home-based work arrangement