Senior Medical Project Coordinator

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🔥 0 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

👷‍♀️ Project Manager

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

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 throughout the project lifecycle • Collaborate with management, stakeholders, client company personnel, and clinical project teams • Perform first-pass review of safety data using line listings, dashboards, and visualization tools • Review safety data for trends, coding consistencies, and potential investigator-site follow-up • Identify, resolve, or escalate potential issues • Prepare safety-data summaries for safety review meetings • Review designated sections of aggregate reports • Act as Project Lead for medical monitoring services when SAE case processing is not contracted • Manage study implementation, coordination, maintenance, and closeout • Serve as primary point of contact for clinical project teams and alliance-level lead on larger studies • Create and maintain medical management plans and align processes with contracts and requested services • Monitor project financial status, forecasting, realization, and team allocations • Coordinate staff projections based on contract values and actual hours • Escalate financial and operational risks and participate in risk management meetings • Determine hours for out-of-scope work and support contract modifications • Resolve complex problems and propose solutions • Assist management with training and mentoring • Present at business development, client, and investigator meetings • Participate in strategy and business development calls • Represent studies at risk management meetings

🎯 Requirements

• Bachelor's degree in Nursing or related Health Sciences, such as Physician's Assistant, or licensed RN • 5+ years of experience providing relevant knowledge, skills, and abilities • 5+ years of clinical safety experience in clinical research monitoring, pharmacovigilance, or a combination of both • Equivalency of appropriate education, training, and/or directly related experience may be considered • Advanced knowledge of GCPs for medical oversight of clinical trials • Knowledge of drug development and safety reporting • Advanced knowledge of safety-data trending, including 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 collaboratively • Ability to maintain a positive and professional demeanor in challenging circumstances

🏖️ Benefits

• Healthy and balanced work environment support • Reasonable accommodation for individuals with disabilities • Career development and collaboration opportunities