Senior Medical Project Coordinator

🔥 0 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

👷‍♀️ Project Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 10%

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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 • Collaborate with management and stakeholders to ensure process consistency, alignment, compliance, performance, and issue resolution throughout the project lifecycle • Represent the company in the medical research community and develop collaborative relationships with client personnel • Perform first-pass reviews of safety data using line listings, dashboards, and visualization tools • Review data for safety trends, coding consistencies, and potential investigator-site follow-up • Identify, resolve, or escalate issues • Review safety data and provide summaries for safety review meetings • Review designated sections of aggregate reports • Serve independently 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 alliance or multi-protocol studies • Create and maintain medical management plans and ensure processes reflect contracts and requested services • Monitor project financial status, unit 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 required for out-of-scope work and support contract modifications • Attend meetings to discuss and justify modification requirements • Resolve complex problems through in-depth evaluation and propose solutions • Assist management with training and mentoring • Present at business-development, client, and investigator meetings and participate in strategy and business-development calls

🎯 Requirements

• Bachelor’s degree in Nursing or related Health Sciences (Physician's Assistant), or licensed RN • 5+ years of experience, including 5+ years of clinical safety experience in clinical research monitoring, pharmacovigilance, or a combination of both • Equivalency may be considered through a combination of appropriate education, training, and directly related experience • 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 in a collaborative team environment • Ability to maintain a positive and professional demeanor in challenging circumstances

🏖️ Benefits

• Healthy and balanced work environment • Collaboration and development opportunities • Career development resources and support