Senior Medical Project Coordinator

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

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.

📋 Description

• Manage, coordinate, and evaluate medical projects for one or more programs • Collaborate with management and other stakeholders for process consistency and compliance • Perform first pass review of safety data • Review data for safety trends, coding consistencies, and potential follow up with investigator sites • Proactively identify any potential issues and resolve or escalate as appropriate • Review safety data and provide summations for safety review meetings • Manage project implementation, coordination, maintenance and close out of assigned studies • Serve as the primary point of contact for clinical project teams on studies • Create and maintain medical management plan(s) on studies • Monitor the project financial status and unit forecasting • Coordinate staff projections based on contract values and actual hours used • Escalate any financial and/or operational risks and attend risk management meetings • Resolve complex problems through in-depth evaluation of various factors and offers solutions • Present at business development, client, and investigator meetings.

🎯 Requirements

• Bachelor's 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 and wellbeing support for employees • Professional development opportunities