Job Responsibilities:
- Responsible for specific clinical/scientific activities on a single study or across multiple studies, as delegated (e.g., medical monitoring, lab specimen tracking/reconciliation, adjudication support, preparation of meeting materials).
- Support development of study protocol and related materials (e.g., ICF documents/amendments, data management deliverables).
- Interact with internal and external stakeholders (e.g., country operations, committees, vendors) in support of clinical study objectives.
- Support development of site and CRA training materials.
- Prepare clinical narratives in support of eDMC meetings or submissions.
- Collaborate cross-functionally to monitor/track clinical study data, deliverables, and/or supplies to ensure quality, completeness, and integrity of trial conduct.
- Contribute to design of vendor deliverables (e.g., EDC, laboratory, ePRO, IRT) aligned with the protocol.
- Support evaluation and tracking of protocol deviations (PDs), trends, and mitigation efforts with medical monitoring teams.
Education Requirements:
- Bachelorโs degree + 2 years OR Masterโs + 1 year pharmaceutical and/or clinical drug development experience (life sciences degree preferred).