07 sep
|
GForce Life Sciences
|
Santander
07 sep
GForce Life Sciences
Santander
Clinical Site Lead (EMEA)
Role Summary
The Clinical Site Lead drives study execution, operational excellence, and site management across multiple therapy areas in accordance with local and international regulations. This role is a recognized subject matter expert in clinical working instructions, clinical investigation plans, and product/disease state throughout the full study lifecycle, from startup through closeout.
Key Responsibilities
- Acts as the primary point of contact, internally and externally, for assigned study sites.
- Coordinates, implements, and executes clinical studies within assigned country/region.
- Identifies, develops, and maintains sites capable of delivering startup goals, study participation levels, and required data quality.
- Identifies appropriate investigators, completes qualification processes, and establishes site/sponsor expectations for study execution.
- Facilitates all aspects of the site startup process, coordinating with Site Operations teams to ensure activation and enrollment within timelines.
- Develops site-specific strategies to promote appropriate patient enrollment.
- Attends study procedures and follow-ups as required per study-specific requirements.
- Monitors clinical studies at sites to ensure compliance with applicable regulatory requirements, Good Clinical Practice, and accuracy standards, including initiation, periodic, and closeout visits.
- Reviews data and source documentation from investigational sites for accuracy and completeness; provides timely feedback to sites.
- Leads, initiates, and coordinates activities to ensure clinical study and regulatory compliance, including Key Compliance Indicator reporting and audit support.
- Ensures adverse events, device complaints, and protocol deviations are reported in a timely manner per regulations and standard procedures.
- Resolves and/or facilitates resolution of site issues, including root cause analysis and preventive actions; reports monitoring visit findings pe
📌 Clinical Site Lead (Santander)
🏢 GForce Life Sciences
📍 Santander