- Serve as the unblinded operational lead for assigned clinical studies, ensuring all activities are conducted in compliance with ICH/GCP, regulatory requirements, and internal procedures.
- Support and manage various study activities, including CROs, country and site selection, informed consent development and maintenance, eCRF design and implementation, protocols, study plans and manuals, IBs, CSRs.
- Oversee study documentation, including study plans, logs, trackers, and training materials.
- Support data review, reconciliation, and issue resolution in collaboration with Data Management, Biostatistics, and Safety teams.
- Maintain appropriate firewalls between blinded and unblinded personnel, ensuring study integrity.
- Provide unblinded operational updates to internal stakeholders while safeguarding treatment-related information.
- Proactively identify and support resolution/escalation of trial conduct-related issues.
- Participate in cross-functional meetings as the unblinded representative, escalating risks and proposing mitigation strategies.
- Support components of site start-up, ongoing monitoring, and closeout activities.
- Contribute to inspection readiness and support regulatory or QA requests related to unblinded processes.
Data management