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, performance, 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 safety data reviews using line listings, company dashboards, and visualization tools
• Review safety trends, coding consistencies, and potential investigator-site follow-up
• Identify, resolve, or escalate potential issues
• Review safety data and prepare summaries for safety review meetings
• Review designated sections of aggregate reports
• Serve 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 alliance-level lead on larger alliance or multi-protocol studies
• Create and maintain medical management plans and ensure processes reflect contracts and requested services
• Monitor project financial status, unit forecasting, actual realization, and team allocations
• Coordinate staff projections based on contract values and actual hours used
• Escalate financial and operational risks and participate in risk management meetings
• Determine hours required for out-of-scope work and support contract modifications
• Resolve complex problems through in-depth evaluation and offer solutions
• Assist management with training and mentoring
• Present at business development, client, and investigator meetings
• Participate in strategy and business development calls

• Bachelor's degree in Nursing or related Health Sciences (Physician's Assistant), or licensed RN
• 5+ years of 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

• Fully remote work mode
• Standard Monday–Friday work schedule
• Career development opportunities
• Resources to achieve individual career goals
• Training and mentoring opportunities
• Equal employment opportunity and affirmative action environment