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Medical Project Coordinator
Thermo Fisher Scientific. Coordinate and review safety data using line listings, company dashboards and visualization tools .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical safety and pharmacovigilance, with a strong foundation in GCPs, safety data trending, and biostatistics. Capable of effectively coordinating safety data reviews, providing solutions to complex problems, and collaborating with project teams.
Highest-signal resume keywords
Clinical Safety ExperienceKnowledge Of GCPsSafety Data TrendingProblem-Solving SkillsCommunication Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Research MonitoringPharmacovigilanceSafety Data ReviewData ManagementBiostatisticsSafety ReportingCoding ConsistenciesAggregate Reports ReviewSafety Management PlansMetrics Review
Soft Skills
Attention To DetailCritical-Thinking SkillsCollaborative WorkProfessional DemeanorTraining And Mentoring
Tools & Technologies
Visualization ToolsCompany DashboardsIn-House SoftwareOff-The-Shelf Software
Certifications & Qualifications
Bachelor’s Degree In NursingLicensed RNPhysician's Assistant
Industry Keywords
GCPsClinical TrialsSAE ProcessingDrug DevelopmentSafety Data
About the role
Key responsibilities & impact- Coordinate and review safety data using line listings, company dashboards and visualization tools
- Review data for safety trends, coding consistencies and potential investigator-site follow-up
- Identify, resolve or escalate safety issues
- Provide safety-data summaries for safety review meetings
- Review designated sections of aggregate reports
- Help create and review safety and medical management plans for studies
- Support routine project implementation, forecasting and coordination, including metrics and budget review
- Monitor data-review status and escalate delays and risks to stakeholders and study leads
- Present at business development, client and investigator meetings
- Participate in strategy and business development calls
- Resolve complex problems and provide solutions
- Serve as primary point of contact for clinical/data management project teams
- Assist management with training and mentoring
Requirements
What you’ll need- Bachelor’s degree in nursing or related Health Sciences (Physician's Assistant) or licensed RN
- 2+ years of previous experience, including 2+ years clinical safety experience in 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
- Knowledge of GCPs for medical oversight of clinical trials and SAE processing
- Knowledge of drug development and safety reporting
- Knowledge of safety data trending, including coding
- Working knowledge of biostatistics, data management and clinical procedures
- Strong problem-solving and critical-thinking skills
- Good oral and written communication skills
- Good attention to detail
- Ability to work collaboratively and maintain a professional demeanor
- Ability to use a variety of in-house and off-the-shelf computer software
- Regular and consistent attendance
- Ability to perform the stated physical and environmental requirements
Benefits
Comp & perks- Global team environment
- Collaboration and development opportunities
- Scientific excellence-focused work environment