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Senior CTM, Internal Medicine – Dermatology, Nephrology, Cardiovascular, Women's Health, GI, Immunology, Rare Disease

🔥 0 minutes ago

🌐 United Kingdom, Romania, +10 more countries – Remote

infoinfo

⏰ Full Time

🟠 Senior

Where this job comes from

Posted on Thermo Fisher Scientific's careers page, not through a job board

First seen by Remote Rocketship 0 minutes ago

Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

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 moderate- to high-complexity studies in compliance with ICH GCP • Assume regional Lead CTM, Clinical Study Manager, process improvement, complex program management, project coordination, or wider management responsibilities as needed • Develop clinical tools such as 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 development of CRFs, CRF guidelines, informed consent templates, and other protocol-specific documents • Collaborate with project managers to prepare and present at client, bid defense, and hand-off meetings • Lead clinical team meetings and coordinate departments to maintain timelines, resources, interactions, and quality • Implement and train standardized clinical monitoring processes • Monitor clinical activity timelines and metrics, provide project status updates, implement recovery actions, review monitoring visit reports, and manage CRF collection and query resolution • Communicate with study sites regarding protocols, patient participation, case report forms, and study issues • Coordinate study start-up activities, regulatory submissions, ethics committee questions, and essential document quality • Provide input into clinical activity forecasts • Manage clinical resources, delegation, assignment of responsibilities, and additional resource requirements • May conduct Accompanied Field Visits and manage project financials • May have limited line management responsibilities on assigned North American GPHS projects

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • 8+ years of previous experience providing relevant knowledge, skills, and abilities • Equivalency through a combination of appropriate education, training and/or directly related experience may be considered • Experience in at least one or more of the listed therapeutic indications • Strong leadership, mentoring, training, motivation, and team integration skills • Strong planning, organizational, interpersonal, problem-solving, judgment, decision-making, escalation, and risk management skills • Strong understanding of change management principles and clinical monitoring practices, processes, and requirements • Effective oral and written communication skills, including English language proficiency • Financial acumen and 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, and automated systems • Ability to independently manage clinical-only studies

🏖️ Benefits

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

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