Senior Regulatory Affairs Specialist, DSMB Expert
20 hours ago
Welcome to Digital Infuzion, where we're dedicated to providing life science researchers with faster insights and health providers with on-demand data and tailored software solutions. As a Senior Regulatory Affairs Specialist, you'll play a critical role in ensuring compliance with regulatory standards and shaping the development of innovative healthcare solutions.
Key Responsibilities- Develop and implement Standard Operating Procedures (SOPs) and Working Practice Guidelines (WPGs) for managing Data Safety Monitoring Boards (DSMBs) within an electronic DSMB management system.
- Collaborate with cross-functional teams to ensure comprehensive coverage of all regulatory requirements related to DSMB activities.
- Implement and monitor quality control procedures to ensure DSMB processes are adhered to and compliant with regulatory guidelines.
- Bachelor's or Master's Degree in a related field.
- Extensive experience in regulatory compliance and SOP development within clinical research, with a focus on DSMB management or similar regulatory oversight boards.
- Strong knowledge of FDA/EMA regulations, GCP guidelines, ICH, and regulatory processes related to DSMBs.
- Proven ability to collaborate with a diverse group of stakeholders.
- Excellent communication, presentation, and training development skills.
- Strong attention to detail and commitment to high-quality, compliant processes.
Digital Infuzion, LLC is an Equal Opportunity Employer. EOE/AA/M/F/D/V
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Rockville, Maryland, United States Digital Infuzion Full timeJob Title: Senior Regulatory Affairs Specialist, DSMB FocusWelcome to Digital Infuzion, where we're dedicated to providing life science researchers with faster insights and health providers with on-demand data and tailored software solutions. Our passion for developing innovative healthcare solutions goes beyond ordinary health IT services to include...
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