Support day-to-day study management; ensure tasks are timely and within budget per Sponsor.
Assist implementation/maintenance of studies; ensure Sponsor/Investigator obligations meet regulatory and GCP.
Assist document management from pre-study to study closure; handling TMF, submissions, meeting minutes.
Support field monitors with checklists, status tracking, and timelines.
Create and file meeting minutes for internal/external study meetings.
Coordinate with TMF team to keep Trial Master File up-to-date.

🎯 Requirements

Bachelor's degree in a biomedical-related field, life sciences or equivalent field
Excellent oral and written communication skills in English
High level of organization, multitasking, judgment and analytical skills
Good time management skills to ensure adherence to timelines
Profound knowledge of Good Clinical Practice, 21 CFR Part 11, and other regulatory requirements
Ability to work well independently and as part of a team

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