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Provide medical leadership and support for clinical trials in nephrology, including protocol creation and real-time medical monitoring. Act as the primary medical liaison between the sponsor and internal departments to ensure subject safety and study compliance.
The Director will engage with senior management to establish strategic department initiatives and drive business development activities for Clinical Assessment Technologies. They are also responsible for overseeing the development of assessment training content and ensuring all materials meet protocol and regulatory requirements.
The Clinical Research Associate II will conduct remote or on-site visits to assess protocol and regulatory compliance, manage documentation, and ensure trials adhere to approved protocols, ICH-GCP guidelines, and SOPs. Key duties involve monitoring investigator sites using a risk-based approach, identifying failures, implementing corrective actions, and ensuring data reliability.
The Principal Biostatistician serves as a resource for the statistical department, mentoring biostatisticians and overseeing training plans. They provide support across all statistical tasks during the project lifecycle and ensure high-quality work is completed on time.
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