Medical Project Coordinator
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Job Description
Medical Project Coordinator supporting Thermo Fisher Scientific’s drug safety operations in Mexico. Coordinating clinical safety data reviews, regulatory compliance, reporting, stakeholder communication, and project implementation.
Responsibilities:
- 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 potential issues and resolve or escalate them appropriately
- Review safety data and provide summations for safety review meetings
- Review designated sections of aggregate reports
- Help create and review safety and medical management plans for studies
- Ensure plan processes reflect contracted services
- Help manage routine project implementation, forecasting, and coordination, including metrics and budget considerations
- Monitor data-review status and escalate delays or risks to stakeholders and study leads
- Present at business development, client, and investigator meetings
- Participate in strategy and business development calls
- Resolve complex problems through in-depth evaluation and offer solutions
- Serve as primary contact for clinical/data management project teams
- Assist management with training and mentoring
Requirements:
- Bachelor’s degree in nursing or related Health Sciences (Physician's Assistant) or licensed RN
- 2+ years of relevant experience
- 2+ years of clinical safety experience in clinical research monitoring, pharmacovigilance, or a combination of both
- Equivalency through 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 in a collaborative team environment
- Ability to maintain a positive and professional demeanor in challenging circumstances
- Ability to work in an upright and/or stationary position for 6–8 hours per day
- Ability to perform repetitive hand movements and frequent mobility
- Ability to lift and carry 15–20 lbs
- Ability to access and use in-house and off-the-shelf computer software
- Ability to communicate and understand spoken and written information
- Ability to perform under stress and multitask
- Regular and consistent attendance
Benefits:
- Collaboration and development as part of the everyday experience
- Reasonable accommodation for individuals with disabilities during application, interview, and essential job functions
- Equal employment opportunity
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