Sr CTM, Internal Medicine

🕒 July 31

🌐 Colombia, Brazil, +4 more countries – Remote

🇨🇴 Colombia – Remote 🇧🇷 Brazil – Remote 🇵🇪 Peru – Remote 🇦🇷 Argentina – Remote 🇨🇱 Chile – Remote 🇲🇽 Mexico – Remote

⏰ Full Time

🟠 Senior

👻 Ghost score 40%

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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, monitoring plans, monitoring guidelines, data quality plans and master action plans • 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 on client meetings, bid defense and hand-off meetings • Coordinate with clinical and other 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 • Monitor clinical activity timelines and metrics, provide project status updates, review tracking tools, implement recovery actions, review monitoring visit reports, and manage CRF collection and query resolution • Monitor or co-monitor clinical trials and ensure contractual obligations are met • Conduct Accompanied Field Visits and manage project financials where applicable • Communicate with study sites regarding protocol, patient participation, case report forms and other study issues • Coordinate study start-up activities and ethics committee and regulatory submissions where appropriate • Ensure essential document quality meets Regulatory Compliance Review expectations and follow up on ethics committee questions • Provide input into clinical activity forecasts • Manage clinical resources, delegate responsibilities and identify additional resource requirements

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • 5+ years of previous experience providing relevant knowledge, skills, and abilities • Equivalent combination of appropriate education, training and/or directly related experience may be considered • Leadership, mentoring, training, team motivation and 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/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 applications

🏖️ Benefits

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