Clinical Team Manager – Internal Medicine

🔥 14 hours ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

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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 moderate- to high-complexity studies in compliance with ICH GCP • Assume Lead CTM, regional Clinical Study Manager, process improvement, program management, management, or project coordination responsibilities as needed • Develop clinical tools, Monitoring Plans, Monitoring Guidelines, Data Quality Plans, Master Action Plans, Trial Master File sections, CRFs, CRF guidelines, informed consent templates, and protocol-specific documents • Collaborate with project managers to prepare, organize, and present client meetings, including bid defense and hand-off meetings • Lead clinical team meetings and coordinate teams and departments to maintain timelines, resources, interactions, and quality • Implement and train standardized clinical monitoring processes • Ensure timely archiving of study documents and materials • Prepare and monitor clinical activity timelines and metrics, provide project status updates, review tracking tools and monitoring visit reports, implement recovery actions, and manage CRF collection and query resolution • Monitor clinical trials to assess performance and meet contractual obligations • Conduct Accompanied Field Visits and manage project financials as needed • Communicate with study sites regarding protocols, patient participation, case report forms, and other study issues • Coordinate study start-up activities and regulatory submissions, and follow up on ethics committee questions • Provide input into clinical activity forecasts • Manage clinical resources, assignment, delegation, and additional resource requirements

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • 5+ years of relevant experience in clinical research, including clinical trial operations, study management, clinical monitoring, or related clinical research activities • Transferable experience in healthcare, nursing, medicine, or related disciplines may be considered in combination with clinical trial experience where the candidate demonstrates significant clinical expertise, therapeutic area knowledge, and direct patient care responsibilities • An equivalency consisting of a combination of appropriate education, training and/or directly related experience may be considered sufficient • Strong leadership, mentoring, training, planning, organizational, interpersonal, problem-solving, judgment, decision-making, escalation, risk management, financial, attention-to-detail, and communication skills • English language proficiency • Strong understanding of change management principles and clinical monitoring practices, processes, and requirements • Knowledge of budgeting, forecasting, and fiscal management • In-depth understanding of relevant regulations, including ICH/GCP and FDA guidelines • Strong computer skills, including Outlook, Excel, Word, automated systems, and computerized applications • Ability to independently manage clinical-only studies • Ability to frequently drive to site locations and travel domestically and internationally

🏖️ Benefits

• Collaboration and development opportunities • Global team environment • Frequent domestic and international travel opportunities

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