Clinical Trials Operations Lead
3 weeks ago
Job Title: Clinical Trials Operations Lead
Location: Worldwide (Remote)
The Sr Clinical Trial Manager will oversee clinical trial sites from start-up to close-out, ensuring compliance with the study protocol, ICH guidelines, Good Clinical Practices (GCP), and regulatory requirements.
This role collaborates with the Clinical Project Manager (CPM), CRO representatives, and vendors to manage clinical studies effectively. Additionally, they may supervise Clinical Trial Managers to ensure deliverables are met on time, within budget, and to quality standards.
- Key Responsibilities:
- Participate in the planning, implementing, and managing of clinical trials in compliance with industry regulations and ICH-GCP.
- Oversight of CROs and clinical trial sites, ensuring timely delivery, meeting recruitment targets, and producing high-quality data.
- Tracking site visit metrics, data quality concerns, and protocol deviations; conduct oversight visits for compliance evaluation.
- Review CRA monitoring reports to ensure protocol and operational compliance; escalate issues for resolution.
- Collaboration with teams for efficient study start-up, identifying risks and ensuring timelines are met.
- Subject matter expert on assigned protocols and management of CRO/site during start-up activities, including contract negotiations and document collection.
- Consistency in Clinical Operations processes across trials and regions.
- Work cross-functionally with departments to meet study requirements and timelines.
- Contribution to developing and reviewing study-related documents and deliver trial-specific training.
- Monitoring open action items and data trends, addressing issues with CROs to enhance study execution and efficiency.
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