- Responsible for all aspects of site management and monitoring of clinical trials
- Manage interactions with all partners (investigators, site teams, internal company departments, external contractors, etc.) to facilitate successful conduct of clinical projects.
- Support clinical research activities as assigned by the supervisor.
- Build strong professional relationships with investigators, site staffs and internal/ external service providers.
- Conduct initiation visits, monitoring visits and site closure visits in collaboration with the clinical project team.
- Maintain the Trial Master File.
- Prepare and negotiate site clinical trial agreements and manage clinical site budget and expenses.
- Preparation of regulatory and ethics submission dossiers.
- Ensure protocol-related safety reporting compliance and address and drive issue resolution.
- Monitor site recruitment and establish/discuss action plans in close collaboration with the Clinical Project Manager.
- Develop and conduct training for investigators and site staffs in the protocol, product and study-specific procedures.
- Coordinate activities to ensure compliance with protocol, GCP, overall clinical objectives as well as company policies and SOP.
- Manage trial product inventory, shipment and storage, and ensure accountability and traceability.
- Ensure that imaging and/ or laboratory samples are collected, handled and shipped according to protocol requirements.
- Ensure that safety reporting of adverse events is completed within required time periods.
- Manage external vendor services for assigned clinical sites.
- Identify issues which affect clinical trial progress and quality, and develop solutions and/ or take action to resolve/ prevent them.
- Deliver projects according to expected targets, budgets and quality standards.
- Monitor and report to clinical management teams on clinical trial progress, performance and plan, including subject recruitment and retention, monitoring activities, data completeness and quality, and site compliance.
- Assist in the organization and conduct of internal and external stakeholder meetings, as required.
- Set up, maintain and update clinical research activities and initiatives in the system.