Clinical Team Manager – FSP

🔥 3 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 • Develop clinical tools and contribute to the Data Quality Plan and Master Action Plan • Ensure timely setup, organization, content, and quality of Trial Master File sections • Participate in designing CRFs, CRF guidelines, informed consent templates, and protocol-specific documents • Collaborate with project managers to prepare and present at client, bid defense, and hand-off meetings • Collaborate with clinical teams and departments to meet project deliverables • Lead team meetings and maintain timelines, resources, interactions, and quality • Implement and train teams on standardized clinical monitoring processes • Archive study documents and materials in a timely manner • Prepare and monitor clinical timelines and metrics, provide project status updates, and implement recovery actions • Review monitoring visit reports, manage CRF collection and query resolution, and monitor clinical trial performance • Conduct Accompanied Field Visits and manage project financials where applicable • Communicate with study sites regarding protocols, patient participation, CRF completion, and related issues • Coordinate study start-up activities and ethics committee and regulatory submissions where applicable • Ensure essential document quality and follow up on ethics committee questions • Contribute to clinical activity forecasts and manage clinical resources, responsibilities, delegations, and additional resource needs

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience comparable to 5+ years • An equivalency consisting of appropriate education, training and/or directly related experience may be considered sufficient • Prior CRA experience preferred by the team • Alzheimer's and/or Neurology experience preferred by the team • Good leadership, mentoring, training, motivation, and team integration skills • Good planning and organizational skills • Solid interpersonal and problem-solving skills • Ability to work effectively in changing environments with complex/ambiguous situations • Familiarity with clinical monitoring practices, processes, and requirements • Good 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 • Good computer skills with Outlook, Excel, Word, and computerized applications

🏖️ Benefits

• Global team environment • Collaboration and development opportunities • Passion, innovation, and commitment to scientific excellence