Senior Medical Project Coordinator

• Manage, coordinate and evaluate medical projects for one or more programs
• Collaborate with management and stakeholders to ensure process consistency, alignment, compliance and issue resolution throughout the project lifecycle
• Represent the company in the medical research community and develop collaborative relationships with client personnel
• Perform first-pass review of safety data using line listings, company dashboards and visualization tools
• Review data for safety trends, coding consistency and potential investigator-site follow-up
• Identify, resolve or escalate potential issues
• Review safety data and provide summaries for safety review meetings
• Review designated sections of aggregate reports
• 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 primary contact for clinical project teams and potentially as alliance-level lead on larger studies
• Create and maintain medical management plans and ensure alignment with contracts and requested services
• Monitor project financial status, unit forecasting, actual realization and team allocations
• Coordinate staff projections and escalate financial or operational risks
• Determine hours required for out-of-scope work and support contract modifications
• Resolve complex problems and offer solutions
• Assist management with training and mentoring
• Present at business development, client and investigator meetings
• Participate in strategy and business development calls
• Represent studies at risk management meetings

• Bachelor’s degree in Nursing or related Health Sciences (Physician's Assistant), or licensed RN
• 5+ years of previous experience providing the knowledge, skills, and abilities to perform the job
• 5+ years of clinical safety experience, including clinical research monitoring, pharmacovigilance, or a combination of both
• Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
• Advanced knowledge of GCPs for medical oversight of clinical trials
• Knowledge of drug development and safety reporting
• Advanced knowledge of safety data trending, including coding
• Working knowledge of biostatistics, data management and clinical procedures
• Excellent problem solving and critical thinking skills
• Excellent project management and budget skills
• Effective mentoring skills and ability to train and lead others
• Strong oral and written communication skills
• Strong attention to detail
• Ability to work in a collaborative team environment
• Ability to maintain a positive and professional demeanor in challenging circumstances
• Ability to work standard Monday-Friday schedule
• Willingness to travel domestically and internationally and occasionally drive to site locations

• Global team environment
• Career development opportunities
• Collaboration and professional development
• Health and wellbeing support
• Personal protective equipment provided as required