Clinical Team Manager – Sr.

🔥 0 minutes ago

🌐 United States, Canada – Remote

🇺🇸 United States – Remote 🇨🇦 Canada – Remote

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

👔 Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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 all aspects of monitoring operations and quality for assigned studies, ensuring compliance with ICH GCP and applicable local regulations • Develop clinical tools and study plans • Collaborate with Biogen CSO, including CCSLs, and lead team meetings to maintain timelines, resources, and quality • Serve as clinical subject matter expert for protocols and escalation point for site managers • Coordinate regionally with regional CMLs as needed • Ensure timely deliverables, monitor trials, communicate with study sites, coordinate start-up activities, address regulatory requirements, and provide input on forecasts and resource management • Complete trip report reviews according to study plan timelines • Escalate issues according to plan and identify, report, and analyze site performance trends • Conduct accompanied site visits with site managers as needed • Attend Sponsor meetings regarding country/region start-up progress, trends, issue identification/escalation, and site/country updates • Generate monitoring plans and trip report completion annotations • Deliver clean data from evaluable patients within contracted timelines • Ensure clinical deliverables meet customer time, quality, and cost expectations • Maintain profitability by managing clinical activities within contract scope • Work independently on projects of moderate to high complexity and potentially assume regional lead or Clinical Study Manager responsibilities

🎯 Requirements

• Bachelor's degree and previous experience comparable to 5+ years • Monitoring or Study Management and Oversight experience preferred • Extensive Neuroscience experience preferred • Prior client-dedicated experience preferred • Advanced mentoring, leadership, and supervisory skills • Excellent clinical trials monitoring skills, including remote and onsite experience • Understanding of, or ability to learn, company SOPs, WPDs, ICH/GCP, and FDA guidelines • Strong organizational and negotiation skills • Strong attention to detail • Advanced written and oral communication skills • Strong knowledge of English language and grammar • Computer proficiency including data entry, archival, and retrieval • Ability to travel as needed • Team-building skills • Interpersonal and conflict-resolution skills • Problem-solving skills in a changing environment • Knowledge of medical/therapeutic areas and medical terminology • Ability to communicate and understand information with diverse groups • Ability to work upright and stationary during typical working hours • Ability to work in non-traditional work environments • Ability to use and learn standard office equipment and technology • Ability to perform under pressure while prioritizing and handling multiple projects • Ability to travel independently up to 20%

🏖️ Benefits

• Annual incentive plan bonus • Healthcare • Employee benefits • Career and development prospects • Innovative, forward-thinking organization • Exciting company culture centered on integrity, intensity, involvement, and innovation