Senior Medical Project Coordinator
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Job Description
Senior Medical Project Coordinator at Thermo Fisher Scientific managing clinical research projects and ensuring compliance for pharmaceutical companies across Latin America.
Responsibilities:
- Manage, coordinate and evaluate medical projects for one or more programs in collaboration with management and other stakeholders.
- Work independently to perform first pass review of safety data, utilizing line listings, company dashboard(s) and/or other visualization tools.
- Review safety data and provide summations for safety review meetings.
- Independently function as the Project Lead for medical monitoring services when SAE case processing has not been contracted.
- Create and maintain medical management plan(s) on studies.
- Work independently to monitor the project financial status, unit forecasting, actual realization, and team allocations in systems.
- Resolving complex problems through in-depth evaluation of various factors and offers solutions.
- Present at business development, client, and investigator meetings and participates in strategy/business development calls.
Requirements:
- Bachelors degree in Nursing or related Health Sciences (Physician's Assistant) or licensed RN
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years)
- 5+ years clinical safety experience (clinical research monitoring, or pharmacovigilance or combination of clinical research monitoring and pharmacovigilance)
- Advanced knowledge of GCPs for medical oversight of clinical trials
- Knowledge of drug development and safety reporting
- Advanced knowledge of safety data trending to include 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
Benefits:
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
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