Clinical Data Coordinator

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

📋 Description

• Offer comprehensive data management assistance to the project team, sponsor, and external vendors.

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

• Oversee study metrics and track study progress, including enrollment and the monitoring/approval of CRFs.

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

• Create ad hoc study reports.

• Conduct user maintenance.

• Support user acceptance testing.

• Contribute to database design efforts.

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

• Help ensure that data management documentation is thorough and up-to-date within the trial master file.

⛳️ Requirements

• Bachelor’s degree or a related field.

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

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

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

• General knowledge of CDASH/SDTM is considered beneficial.

• Highly organized and detail-oriented, possessing effective project planning and time management skills.

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

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

• Strong interpersonal, communication, problem-solving, and organizational abilities.

• Capacity to work independently as well as collaboratively in a team setting.

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

• Must be legally authorized to work in the Philippines.

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

🏝️ Benefits

• Flexible work schedule.

• Permanent full-time position.

• Continuous learning and development opportunities.

• Attractive prospects for advancement.

• Home-based work location.