Clinical Trial Manager

🕒 6 days ago

🇲🇽 Mexico – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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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 plan contributions • Ensure timely setup, organization, content, and quality of relevant Trial Master File sections • Participate in designing CRFs, CRF guidelines, informed consent templates, and other 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 maintain timelines, resources, interactions, and quality • Lead team meetings and implement and train 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, and review monitoring visit reports • Manage CRF collection and query resolution and monitor or co-monitor clinical trials • Conduct Accompanied Field Visits and manage project financials in smaller regions when required • Communicate with study sites about protocol, patient participation, case report forms, and other 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 and manage clinical resources, assignments, delegation, and additional resource requirements

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • 5+ years of previous relevant experience or comparable experience providing the required knowledge, skills, and abilities • An equivalency consisting of appropriate education, training and/or directly related experience may be considered • Leadership, mentoring, training, and team motivation skills • Planning and organizational skills • Interpersonal and problem-solving skills in a multicultural matrix organization • Familiarity with clinical monitoring practices, processes, and requirements • 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 other automated systems • Ability to frequently drive to site locations and travel domestically and internationally

🏖️ Benefits

• Global team environment • Collaboration and development opportunities • Frequent domestic and international travel • Standard Monday–Friday work schedule

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