Clinical Team Manager – FSP

🔥 13 hours ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 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 clinical operational and quality aspects of allocated low- to moderate-complexity studies in compliance with ICH GCP • Assume Clinical Study Manager responsibilities on small or less complex projects when required • Develop clinical tools, monitoring plans, monitoring guidelines, and contribute to the Master Action Plan • Set up, organize, maintain, and archive relevant Trial Master File sections and study materials • Participate in designing CRFs, CRF guidelines, patient informed consent templates, and protocol-specific documents • Collaborate with project managers to prepare and present client meetings, including bid defense and hand-off meetings • Collaborate with clinical and cross-functional teams and lead team meetings • Implement and train teams on standardized clinical monitoring processes • Prepare and monitor clinical activity timelines and metrics, provide project status updates, and implement recovery actions • Review monitoring visit reports and manage CRF collection and query resolution • Monitor or co-monitor clinical trials to assess performance and meet contractual obligations • Conduct Accompanied Field Visits and manage project financials in smaller regions when required • Communicate with study sites regarding protocol, patient participation, CRF completion, and related issues • Coordinate study start-up activities and ethics committee and regulatory submissions when required • Review and follow up on ethics committee questions • Provide input into clinical activity forecasts and manage clinical resources, delegation, and additional resource requirements

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • 5+ years of previous comparable experience • Equivalency through a combination of appropriate education, training and/or directly related experience may be considered • Leadership, mentoring, training, motivation, and team integration skills • Planning and organizational skills • Interpersonal and problem-solving skills in a multicultural matrix organization • Ability to work effectively in changing environments with complex or ambiguous situations • Familiarity with clinical monitoring practices, processes, and requirements • Judgment and decision-making skills • Effective oral and written communication skills, including English language proficiency • Ability to evaluate workload against project budget and adjust resources • Financial acumen and knowledge of budgeting, forecasting, and fiscal management • Strong attention to detail • Understanding of relevant regulations, including ICH/GCP and FDA guidelines • Computer skills using Outlook, Excel, Word, and similar automated systems • Frequent domestic and international travel and driving to site locations

🏖️ Benefits

• Global team environment • Collaboration and development opportunities • Scientific excellence-focused workplace