Director, Clinical Safety & Medical Monitoring CRO
NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.
We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry’s premier provider. We provide support for clients during every step of the product development lifecycle and beyond.
Come and work for an organization with the:
Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the
Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core
Values:
- Act with integrity in everything we do.
- Provide best-in-class customer experiences.
- Develop superior talent and deliver expertise.
- Respond with agility and provide timely results.
- Embrace collaboration, diverse perspectives and ideas.
Compensation Target:
$225,000.00 Job Description:
• Actively works to promote operational excellence by monitoring and improving processes related to management of Individual Safety Case Reports of Adverse Events / Serious Adverse Events (ICSRs), Clinical Events Committees (CECs), and Data Monitoring Committees (DMCs).
• Develops and/or maintains knowledge of current Good Clinical Practices, Good Vigilance Practices, Safety best writing practices, and data entry conventions.
• Acts as a leader and mentor to Safety team members and non-Safety staff. Develops individualized training plans for new hires and onboards incoming staff to Safety department.
• Accomplishes department financial objectives by assisting with forecasting requirements/capacity; preparing annual budgets; scheduling and overseeing expenditures, analyzing variances; and initiating corrective actions.
• Maintains qualified staff by recruiting, selecting, orienting, and training Associates, and developing personal growth opportunities via training plans, quality oversight/assurance and/or career path planning.
• Allocates workload for client projects.
• Model and instill exceptional customer service across the team by acting collaboratively, being responsive to client requests, communicate thoughtfully, and maintain high standards of quality.
• Seek opportunities to work cross-functionally to provide solutions to clients within the context of client projects, business strategy, and internal initiatives.
• In collaboration with Finance and Senior Leadership, solves issues related to financial objectives for department.
• Provides content and / or review of departmental Standard Operating Procedures, work instructions, forms, training materials, guides, and templates.
• In collaboration with other Safety Management, identifies departmental or Company-level risks and executes mitigation plans.
• Attends company management meetings to provide Safety departmental and project updates upon request.
• Participates in developing departmental key performance/quality indicator metrics, staff performance evaluation documentation, and performance improvement plans.
• Supports Safety study team members in creating project plans and charters based on study protocol and sponsor requirements. Acts as first point of escalation within the Safety department for study-related sponsor questions/concerns. Attends study team meetings as needed to support assigned Safety team members.
• Supports Safety team members in tracking incoming ICSR reports to ensure all case versions are processed according to project documents and protocol requirements.
• Reviews and quality checks Safety reports prepared by assigned Safety team members prior to sponsor review and regulatory
submission, including ICSR reports and periodic aggregate data reports. May delegate quality control work for Pharma