Global Clinical Research Operations Lead
hace 2 semanas
This role requires a seasoned professional with experience in clinical research operations. The ideal candidate will have a strong background in site management, monitoring, and compliance. The following responsibilities are key aspects of this position:
- SITE RELATIONSHIPS: Develop and maintain strong relationships with investigators and site staff to ensure seamless conduct of clinical studies.
- CLINICAL STUDY SITE MANAGEMENT: Oversee the management of clinical study sites, ensuring compliance with ICH/GCP, sponsor SOPs, local laws and regulations, protocol, site monitoring plan, and associated documents.
- STUDY PROTOCOL KNOWLEDGE: Develop in-depth knowledge of study protocols and related procedures to effectively manage and monitor clinical studies.
- TASK COORDINATION: Coordinate and manage various tasks in collaboration with other sponsor roles to achieve study milestones.
- SITE SELECTION AND VALIDATION: Participate in site selection and validation activities to identify suitable sites for clinical studies.
- MONITORING AND OVERSIGHT: Conduct regular monitoring and oversight activities to ensure data integrity, subject safety, and compliance with regulatory requirements.
- VISIT PLANNING AND EXECUTION: Plan and execute site visits, including validation, initiation, monitoring, and close-out visits, to ensure timely completion of studies.
- REGULATORY DOCUMENTATION: Manage and maintain regulatory documentation, including study-related paperwork and records.
- COMMUNICATION: Effectively communicate with investigators, site staff, and other stakeholders to address study-related issues and concerns.
- PROBLEM RESOLUTION: Identify and resolve study-related problems and escalate them to senior management as needed.
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Clinical Research Site Specialist Lead
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Sr. Spclst, Clinical Research
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Country Clinical Quality Manager
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