Associate Director, Safety Management

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RQM+ is The Med Tech CRO, accelerating innovation to patient impact. Our tailored solutions deliver regulatory and quality expertise, FDA-recognized laboratory services, clinical trials, and reimbursement strategies across device types and therapeutic areas to bring life-changing technologies to patients — faster, safer, better.

We don’t make Med Tech. We make Med Tech happen.

Our experienced teams are cohesive, collaborative, and proactive, constantly seeking to improve and evolve while remaining laser-focused on customer success. RQM+ elevates the Med Tech experience through best-in-class service and clear, concise communication. We serve as an extension of our customers establishing and maintaining excellent client and site relationships and providing direct access to our technology platforms for real-time data and study transparency.

The Associate Director, Safety Management is a member of the core team responsible for safety and medical affairs oversight and leadership in accordance with SOPs, policies and corporate practices. The Associate Director, Safety Management is focused on staff leadership, mentoring and assisting delivery, productivity and quality resulting in strong performance and customer satisfaction. Additionally, the Associate Director supports the function with meeting department goals and identifying process improvement.

The Associate Director, Safety Management, may be assigned their own studies, as part of their professional development while being primarily focused on staff development and support.

• Responsible for activities related to safety management in medical device clinical studies. Works with clients to ensure RQM+’s operational processes are maintained while projects are completed within scope and budget.
• Manages team schedules and assigns tasks to ensure resource allocation is sufficient across projects.
• Ensures consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
• Provides input to the maintenance and improvement of functional standard operating procedures, forms and templates.
• Coordinate, track and manage daily operations of clinical safety management team, including:
  • Lead safety and vigilance activities for medical device and drug clinical trials, including adverse event (AE) and serious adverse event (SAE) assessment, documentation, and reporting
  • Ensure appropriate evaluation of device-relatedness, expectedness, and reportability in accordance with applicable regulations and study protocols
  • Monitor device deficiency and safety reports for trends requiring escalation to the Sponsor for Root Cause Investigation and support the collection and evaluation of information necessary to assess potential safety concerns.
  • Oversee safety data review and trend analysis to identify potential safety signals and emerging risks
  • Provide safety and risk management input to clinical trial protocols, Investigator’s Brochures, informed consent forms, clinical monitoring plans, and risk management documentation
  • Participate in internal and sponsor-led safety review meetings, Data Safety Monitoring Boards (DSMBs), Clinical Endpoint Committee (CEC) and clinical governance forums, as applicable
  • Collaborate with Clinical Operations and Medical Monitoring to ensure consistent safety escalation and management processes
  • Support development and maintenance of device risk management files in alignment with ISO 14971
  • Assess safety trends and recommend mitigation strategies, protocol modifications, or corrective actions as needed
• Provides regular reports to…