Clinical Data Coordinator

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

📋 Description

• Engage in clinical data management activities 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.

• Carry out tasks in compliance with regulatory standards, industry guidelines, Indero SOPs, sponsor requirements, and established timelines.

• Provide comprehensive data management assistance to the project team, sponsors, and external vendors.

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

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

• Create ad-hoc study reports.

• Conduct user maintenance tasks.

• Aid in user acceptance testing.

• Contribute to database design efforts.

• Help in the development of the data management plan and associated documentation.

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

⛳️ Requirements

• Bachelor’s degree or equivalent in a related field.

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

• Proficiency in using an EDC system (e.g., Medidata Rave, Medrio) is regarded as a significant advantage.

• Competent in utilizing computer technology and capable of learning new applications.

• A foundational understanding of CDASH/SDTM is seen as an asset.

• 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.

• Strong interpersonal, communication, problem-solving, and organizational skills, with the capacity to work independently and collaboratively in a team setting.

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

• Legally authorized to work in India.

🏝️ Benefits

• Flexible work schedule.

• Permanent full-time employment.

• Comprehensive company benefits package.

• Continuous learning and development opportunities.

• Attractive opportunities for career advancement.

• Engaging work environment.