Clinical Team Manager – Internal Medicine

🕒 August 2

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

🦅 H1B Visa Sponsor

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👻 Ghost score 30%

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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, Clinical Study Manager, regional lead, process improvement, program management, or project coordination responsibilities as required • Develop clinical tools, including Monitoring Plans and Monitoring Guidelines, with the Data Quality Plan • Contribute to the Master Action Plan and ensure timely setup, organization, content, and quality of Trial Master File sections • Participate in developing CRFs, CRF guidelines, patient informed consent templates, and other protocol-specific documents • Collaborate with project managers to prepare, organize, and present client meetings, including bid defense and hand-off meetings • Lead team meetings and coordinate clinical teams and other departments to maintain timelines, resources, interactions, and quality • Implement and train teams on standardized clinical monitoring processes and corporate policies • Archive documents and study materials in a timely manner • Monitor clinical activity timelines and metrics, provide project status updates, implement recovery actions, review monitoring visit reports, and manage CRF collection and query resolution • Continuously monitor trial performance and contractual obligations; conduct Accompanied Field Visits and manage project financials as needed • Communicate with study sites regarding protocols, patient participation, case report forms, and study-related issues • Coordinate study start-up activities, regulatory submissions, ethics committee questions, and essential document quality as required • Provide input into clinical activity forecasts • Manage clinical resources, assign and delegate responsibilities, and identify 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 • Effective oral and written communication skills, including English language proficiency • In-depth understanding of relevant regulations, including ICH/GCP and FDA guidelines • Comprehensive understanding of clinical monitoring practices, processes, and requirements • Strong computer skills, including Outlook, Excel, Word, and computerized applications • Strong financial acumen and knowledge of budgeting, forecasting, and fiscal management • Ability to independently manage clinical-only studies • Strong leadership, mentoring, training, planning, organizational, interpersonal, problem-solving, judgment, decision-making, escalation, risk management, and attention-to-detail skills • Willingness and ability to frequently drive to site locations and travel domestically and internationally

🏖️ Benefits

• Global team environment • Collaboration and development opportunities • Standard Monday–Friday work schedule