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Senior Regulatory Affairs Specialist, DSMB Expert

4 weeks ago

Rockville, Maryland, United States Digital Infuzion Full time
Job Title: Senior Regulatory Affairs Specialist, DSMB Focus

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. Our passion for developing innovative healthcare solutions goes beyond ordinary health IT services to include comprehensive translational research support.

Job Summary

We're seeking a Senior Regulatory Affairs Specialist to lead the development of Standard Operating Procedures (SOPs) and Working Practice Guidelines (WPGs) for managing Data Safety Monitoring Boards (DSMBs) within an electronic DSMB management system. In this role, you'll ensure that every aspect of DSMB activities meets regulatory standards and reflects best practices in the field.

Key Responsibilities:
  • Develop and implement SOPs and WPGs for managing DSMB activities, including charter creation, roster management, meeting scheduling, data review, safety reporting, decision-making, follow-up actions, and documentation.
  • 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.
  • Develop and deliver training programs to onboard teams to the newly developed DSMB SOPs, ensuring that all personnel are fully trained and capable of implementing the procedures.
Requirements
  • 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

We're committed to providing equal employment opportunities without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, marital status, veteran status, genetic information, or any other protected characteristic under applicable law.