Clinical Trial Manager

🔥 1 hour ago

🇨🇴 Colombia – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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 • Assume Clinical Study Manager responsibilities on small or less complex projects when required • Develop clinical tools, Monitoring Plans, Monitoring Guidelines, and contribute to Data Quality Plans and Master Action Plans • Ensure timely setup, organization, content, and quality of relevant 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 client meetings, including bid defense and hand-off meetings • Collaborate with clinical teams 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 documents and study materials in a timely manner • Prepare and monitor clinical activity timelines and metrics • Provide project status updates, review projects using tracking tools, and implement recovery actions • Review monitoring visit reports, manage CRF collection and query resolution • Monitor or co-monitor clinical trials to assess performance and meet contractual obligations • Conduct Accompanied Field Visits and manage project financials in smaller regions when required • Communicate with study sites regarding protocol, patient participation, case report forms, and study issues • Coordinate study start-up activities and ethics committee and regulatory submissions when appropriate • Ensure essential document quality 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 comparable experience • Equivalency through a combination of appropriate education, training and/or directly related experience may be considered • Leadership, mentoring, training, motivation, and team 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 • Good judgment and decision-making skills • Effective oral and written communication skills, including English language proficiency • Ability to evaluate workload against project budgets 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 • Frequent domestic and international travel and driving to site locations

🏖️ Benefits

• Global team environment • Collaboration and development opportunities • Passion, innovation, and commitment to scientific excellence • Standard Monday-Friday work schedule