Lead Medical Project Coordinator

• Lead the management, coordination, and evaluation of medical projects across one or more programs
• Collaborate with management and stakeholders to ensure process consistency, alignment, compliance, performance, and issue resolution throughout the project lifecycle
• Represent Thermo Fisher Scientific in the medical research community and liaise with clients
• Independently perform or lead first-pass reviews of safety data using line listings, dashboards, and visualization tools
• Review safety trends, coding consistency, and potential investigator-site follow-up; identify, resolve, or escalate issues
• Prepare comprehensive safety-data summaries for safety review meetings and review designated sections of aggregate reports
• Lead initiatives to improve medical-monitoring and department-service processes
• Develop guidance documents and assist with implementing or revising SOPs and WPDs
• Serve independently as Project Lead for medical-monitoring services when SAE case processing is not contracted
• Manage study implementation, coordination, maintenance, and closeout
• Serve as the primary contact for clinical project teams and alliance-level lead for larger alliance or multi-protocol studies
• Create and maintain safety and medical-management plans and ensure alignment with contracts and requested services
• Monitor project financial status, forecasting, realization, and team allocations; coordinate staff projections
• Escalate financial and operational risks and participate in risk-management meetings
• Present at business-development, client, and investigator meetings and participate in strategy and business-development calls
• Determine hours required for out-of-scope medical-monitoring and medical-project-coordination work and support contract modifications
• Train and develop new team members; serve as a point of contact for questions
• Organize and lead team meetings to address process issues, questions, and solutions
• Resolve complex problems through in-depth evaluation and recommend solutions

• Bachelor’s degree in Nursing or related Health Sciences (Physician's Assistant) or licensed RN
• 8+ years of previous experience comparable to the role
• 8+ years of clinical safety experience, including clinical research monitoring, pharmacovigilance, or a combination of both
• Equivalency may be considered through a combination of appropriate education, training, and/or directly related experience
• Superior knowledge of GCPs for medical oversight of clinical trials
• Advanced knowledge of drug development and safety reporting
• Extensive knowledge of safety data trending, including coding
• Good knowledge of biostatistics, data management, and clinical procedures
• Exceptional problem-solving and critical-thinking skills
• Exceptional project management and budget skills
• Excellent mentoring skills and ability to train and lead others
• Exceptional oral and written communication skills
• Detail-oriented mindset
• Ability to work in a collaborative team environment
• Ability to maintain a positive and professional demeanor in challenging circumstances
• Ability to work in an office, laboratory, and/or clinical environment
• Ability to work with potential exposure to biological fluids and infectious organisms
• Ability to use required personal protective equipment, including protective eyewear, garments, and gloves

• Fully remote work arrangement
• Standard Monday–Friday work schedule
• Collaboration and development opportunities
• Resources to achieve individual career goals
• Training and development opportunities
• Opportunity to contribute to life-changing therapies and meaningful scientific work