Director, Clinical Safety – Medical Monitoring

This is a fully remote position, open to applicants in Ohio, +1 more state.

📋 Description

• Oversee and enhance processes related to Individual Safety Case Reports, Clinical Events Committees, and Data Monitoring Committees.

• Stay updated on Good Clinical Practices, Good Vigilance Practices, safety writing standards, and data entry protocols.

• Lead, mentor, recruit, select, orient, and train members of the Safety team as well as non-Safety personnel.

• Create tailored training plans, quality oversight strategies, and career advancement opportunities.

• Anticipate departmental needs and capacity, develop budgets, monitor expenses, assess variances, and implement corrective measures.

• Distribute workload for client projects effectively.

• Foster outstanding customer service and engage in cross-functional collaboration to address client needs.

• Formulate and assess departmental SOPs, work instructions, forms, training materials, guides, and templates.

• Recognize risks at both the departmental and company levels and execute strategies for mitigation.

• Provide updates on Safety departmental and project status during company management meetings.

• Establish performance and quality metrics, staff evaluation documentation, and plans for performance enhancement.

• Assist study team members with project plans, charters, inquiries from sponsors, and study meetings.

• Monitor incoming ICSR reports and ensure that case versions align with project and protocol specifications.

• Review and quality-check Safety reports prior to sponsor review and regulatory submission.

• Represent the Safety department during internal audits, sponsor audits, regulatory inspections, and business development initiatives.

• Aid in revenue forecasting, sponsor invoicing, and management of study budgets.

• Act as a scientific, technical, and strategic consultant for NAMSA and client teams.

• Collaborate with clients on product development, clinical strategies, scientific considerations, and regulatory pathways.

• Contribute to medical writing, literature reviews, data analysis, clinical evaluation plans and reports, protocols, and study reports.

• Advise clients on the full spectrum of NAMSA’s services.

• Serve as a point of contact between clients and executive-level stakeholders.

• Inspire teams, adjust project strategies, mitigate risks, and ensure the successful completion of high-quality projects.

• Provide medical oversight for safety, medical writing, and regulatory processes.

• Support business development activities.

• Collaborate with Biostats on the creation and review of TLF shells.

⛳️ Requirements

• Doctor of Medicine degree with postgraduate training from an accredited institution.

• Minimum of 5 years of relevant experience.

• Current medical license is preferred.

• Strong passion for Science, Mathematics, and Healthcare.

• Familiarity with the MedTech industry.

• Excellent leadership and communication abilities.

• Capacity to work independently.

• Strong organizational skills with a keen eye for detail.

• Knowledge of GCP, ICH, and FDA regulations as they pertain to Clinical Data Science.

• High level of personal and professional integrity.

• Willingness to travel as required for conferences and client meetings.

• Proficiency in Microsoft Word, Excel, and other medical writing tools.

• Expertise in conducting targeted literature searches using PubMed, MedLine, or similar medical literature databases.

• Ability to speak or hear, stand, walk, sit, use hands to manipulate objects, and reach with hands and arms.

• Capability to occasionally lift or move items weighing up to 25 pounds.

• Good vision, depth perception, and ability to adjust focus.

• Extensive keyboard use.

🏝️ Benefits

• Compensation target of $225,000.00.

• Flexibility to work remotely.

• Reasonable accommodations for individuals with disabilities.

• Travel opportunities for conferences and client meetings.