
10,000+ employees
Founded 1956
🧬 Biotechnology
💊 Pharmaceuticals
🔬 Science
Biotechnology • Pharmaceuticals • Science
Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.
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10,000+ employees
Founded 1956
🧬 Biotechnology
💊 Pharmaceuticals
🔬 Science
Biotechnology • Pharmaceuticals • Science
Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.
• Manages, coordinates and evaluates medical projects for one or more programs • Represents the company in the medical research community and develops collaborative relationships with client company personnel • Works independently to perform first pass review of safety data • Reviews data for safety trends, coding consistencies, and potential follow up with investigator sites • Proactively identifies any potential issues and resolves or escalates as appropriate • Independently functions as the Project Lead for medical monitoring services • Manages project implementation, coordination, maintenance and close out of assigned studies as applicable • Serves as the primary point of contact for clinical project teams on studies • Creates and maintains medical management plan(s) on studies • Independently determines hours required for out of scope work for the teams • Attends meetings to discuss/justify the modification requirements • Resolves complex problems through in-depth evaluation of various factors and offers solutions
• 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 project management and budget skills • Effective mentoring skills and ability to train and lead others • Strong attention to detail
• Health insurance • Professional development opportunities • Flexible working hours
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