Clinical Data Coordinator

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

📋 Description

• Engage in clinical data management tasks to ensure that clinical trial data is collected, managed, and reported in a clear, accurate, and secure manner.

• Execute activities in accordance with regulatory standards, industry guidelines, Indero standard operating procedures, sponsor requirements, and established timelines.

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

• Aid the Lead Data Manager with data review, reconciliation, and discrepancy management.

• Track study metrics and oversee study progress, including enrollment and the monitoring/approval of CRFs.

• Deliver data status reports to the project team as required.

• Create ad-hoc study reports.

• Conduct user maintenance tasks.

• Support user acceptance testing efforts.

• Assist in database design initiatives.

• Help draft data management plans and associated documentation.

• Contribute to ensuring that data management documentation is comprehensive and current in the trial master file.

⛳️ Requirements

• Bachelor’s degree or related field.

• One year of clinical data management experience within the pharmaceutical industry or a CRO environment is viewed as an advantage.

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

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

• A basic understanding of CDASH/SDTM is considered beneficial.

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

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

• Ability to thrive in a fast-paced environment, demonstrating agility in managing and prioritizing multiple competing demands.

• Outstanding interpersonal, communication, problem-solving, and organizational skills, with the capacity to work both independently and collaboratively within a team.

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

• Must be legally authorized to work in Argentina.

🏝️ Benefits

• Flexible work schedule.

• Home-based role.

• Continuous learning and development opportunities.

• Attractive opportunities for advancement.

• Accommodations available during the recruitment and selection process for applicants with disabilities, upon request.