Senior Regulatory Affairs Specialist, DSMB Focus

Rockville, MD
Full Time
Experienced
Welcome! At Digital Infuzion, we believe that everyone deserves to live a better, healthier life. That's why 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. If you're looking for a creative, open, and growth-oriented environment where you can do what you love while helping people live healthier lives, then keep scrolling - we may have just the opportunity for you.

Career Opportunity
Are you looking for an opportunity to drive innovation in healthcare and make a meaningful impact on patient outcomes? This position in regulatory affairs offers the chance to not only ensure compliance with the highest standards but also to shape how cutting-edge platforms are used to streamline clinical research operations. You’ll collaborate with diverse teams to oversee DSMB activities, ensuring they meet rigorous regulatory standards, while leading training programs that empower others to excel. If you're ready to lead with purpose and be a catalyst for positive change, this role is for you.

Position Overview
We are 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 will ensure that every aspect of DSMB activities meets regulatory standards and reflects best practices in the field. Once the SOPs are established, you’ll take the lead in training teams to guarantee consistent adherence and compliance. If you’re ready to take the next step in your career and make a meaningful impact, we invite you to explore this exciting opportunity with us!

Key Responsibilities:

SOP Development and DSMB Process Management:
  • Lead the design and creation of SOPs and WPGs for managing DSMB activities in an electronic DSMB management system, including charter creation, roster management, meeting scheduling, data review, safety reporting, decision-making, follow-up actions, and documentation.
  • Ensure that all electronic DSMB management system processes align with FDA/EMA regulations, Good Clinical Practice (GCP) guidelines, ICH and NIH and internal policies.
  • Collaborate with cross-functional teams, including compliance specialists, risk experts, and project managers, to ensure comprehensive coverage of all regulatory requirements related to DSMB activities.

Regulatory Compliance and Quality Assurance:
  • Ensure that SOPs and guidelines comply with relevant regulatory frameworks, including GCP, FDA, and other applicable international regulations, particularly for DSMB activities.
  • Implement and monitor quality control procedures to ensure DSMB processes are adhered to and compliant with regulatory guidelines.
  • Regularly report on DSMB activities, compliance status, and quality assurance results to leadership and stakeholders, mitigating any risks that may arise.

Training and Capacity Building:
  • Develop and deliver a training program to onboard teams to the newly developed DSMB SOPs, ensuring that all personnel are fully trained and capable of implementing the procedures.
  • Create training materials such as guides, presentations, and workshops to ensure clear understanding and application of DSMB processes in the electronic DSMB management system.
  • Provide ongoing support and refresher training as needed to maintain compliance and reinforce best practices.

Cross-Functional Collaboration:
  • Work closely with project teams, DSMB chairs, clinical researchers, and technical experts to integrate DSMB SOPs into pre-existing operational workflows within the electronic management system.
  • Collaborate with leadership to continuously improve DSMB management processes, ensuring efficiency and compliance with evolving regulatory requirements.

Requirements
  • Bachelor’s or Master’s Degree in 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.
  • Proactive and self-motivated

Digital Infuzion, LLC is an Equal Opportunity Employer. EOE/AA/M/F/D/V  
Digital Infuzion, LLC’s policy is to provide 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. 
 
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