Clinical Data Coordinator

This is a fully remote position, open to applicants in South Africa.

📋 Description

• Engage in clinical data management tasks for clinical trials conducted or overseen by Indero.

• Ensure that clinical trial data is gathered, managed, and reported in a clear, accurate, and secure manner.

• Execute activities in compliance with regulatory standards, industry guidelines, Indero SOPs, sponsor requirements, and project timelines.

• Offer general data management assistance to the project team, sponsors, and external vendors.

• Support the Lead Data Manager with data review, reconciliation, discrepancy management, maintenance of study metrics, and monitoring of study status.

• Provide data status updates to the project team as required.

• Create ad-hoc study reports.

• Conduct user maintenance.

• Assist with user acceptance testing.

• Contribute to database design.

• Help in developing the data management plan and related documentation.

• Aid in ensuring that data management documentation is complete and current in the trial master file.

⛳️ Requirements

• Bachelor’s degree or a related field.

• One year of clinical data management experience in the pharmaceutical sector or within a CRO environment is considered advantageous.

• Familiarity with an EDC system (e.g., Medidata Rave, Medrio) is regarded as a significant asset.

• Proficient in computer technology and capable of learning new applications.

• General understanding of CDASH/SDTM is seen as beneficial.

• Highly organized and detail-oriented with effective project planning and time management abilities.

• Strong verbal and written communication skills in English; proficiency in French is a plus.

• Capability to thrive in a fast-paced environment and manage multiple competing priorities.

• Excellent interpersonal, communication, problem-solving, and organizational skills.

• Ability to work autonomously as well as collaboratively within a team.

• Comprehension of the drug development process and relevant regulations, including Good Clinical Practices, ICH Guidelines, and applicable Health Canada and FDA regulations/guidelines.

• Must possess legal authorization to work in South Africa.

• Availability to attend certain meetings outside of regular business hours, primarily in the evening.

🏝️ Benefits

• Flexible work schedule.

• Permanent full-time position.

• Continuous learning and development opportunities.

• Attractive prospects for advancement.

• Home-based work arrangement.