Director, Clinical Safety – Medical Monitoring

Job not on LinkedIn

🔥 0 minutes ago

🏈 Ohio, Minnesota – Remote

🏈 Ohio – Remote ❄️ Minnesota – Remote

💵 $152.3k - $296.6k / year

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

👻 Ghost score 0%

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NAMSA

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1967

🏥 Healthcare

🏭 Manufacturing

📦 Logistics

Healthcare • Manufacturing • Logistics

NAMSA is a global leader in medical device testing and research, offering comprehensive consulting, preclinical research, clinical research, and testing services for medical device and IVD manufacturers worldwide. With a team of over 1,400 specialists and state-of-the-art labs across North America, Europe, and Asia, NAMSA conducts extensive testing to ensure the safety, efficacy, and compliance of medical devices. The company provides strategic consulting on regulatory submissions and market strategies, helping clients navigate complex regulatory landscapes efficiently and effectively. Founded in 1967, NAMSA is trusted by manufacturers to deliver high-quality services from concept to commercialization.

📋 Description

• Monitor and improve processes for Individual Safety Case Reports, Clinical Events Committees, and Data Monitoring Committees • Maintain knowledge of Good Clinical Practices, Good Vigilance Practices, safety writing practices, and data entry conventions • Lead, mentor, recruit, select, orient, and train Safety team members and non-Safety staff • Develop individualized training plans, quality oversight plans, and career path opportunities • Forecast department requirements and capacity, prepare budgets, oversee expenditures, analyze variances, and initiate corrective actions • Allocate workload for client projects • Promote exceptional customer service and collaborate cross-functionally on client solutions • Develop and review departmental SOPs, work instructions, forms, training materials, guides, and templates • Identify departmental and company-level risks and execute mitigation plans • Provide Safety departmental and project updates in company management meetings • Develop performance and quality metrics, staff evaluation documentation, and performance improvement plans • Support study team members with project plans, charters, sponsor questions, and study meetings • Track incoming ICSR reports and ensure case versions meet project and protocol requirements • Review and quality-check Safety reports before sponsor review and regulatory submission • Represent Safety in internal audits, sponsor audits, regulatory inspections, and business development opportunities • Support revenue forecasting, sponsor invoicing, and study budget management • Serve as a scientific, technical, and strategic consultant to NAMSA and client teams • Collaborate with clients on product development, clinical, scientific, and regulatory strategies • Contribute to medical writing, literature reviews, data analysis, clinical evaluation plans and reports, protocols, and study reports • Advise clients on NAMSA’s full range of services • Serve as liaison with clients and executive-level stakeholders • Motivate teams, adjust project plans, mitigate risks, and achieve high-quality project completion • Provide medical supervision for safety, medical writing, and regulatory activities • Assist with business development responsibilities • Work with Biostats on construction and review of TLF shells

🎯 Requirements

• Doctor of Medicine degree and postgraduate training from an accredited institution • At least 5 years of relevant experience • Current medical license preferred • Strong interest in Science, Mathematics, and Healthcare • Knowledge of the MedTech industry • Strong leadership and communication skills • Ability to work independently • Strong organizational skills with attention to detail • Familiarity with GCP, ICH and FDA requirements as applicable for Clinical Data Science • High degree of personal and professional integrity • Willingness to travel as necessary for conferences and client meetings • Knowledge and experience with Microsoft Word, Excel and other medical writing tools • Expertise in conducting focused literature searches on PubMed, MedLine or similar medical literature databases • Ability to talk or hear, stand, walk, sit, use hands to finger, handle or feel, and reach with hands and arms • Ability to occasionally lift or move up to 25 pounds • Close vision, depth perception, and ability to adjust focus • Extensive use of a computer keyboard

🏖️ Benefits

• Compensation target of $225,000.00 • Opportunity to work remotely • Reasonable accommodations for individuals with disabilities • Travel opportunities for conferences and client meetings