Senior Clinical Trial Manager, FSP

🔥 0 minutes ago

🇲🇽 Mexico – Remote

⏰ Full Time

🟠 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 moderate- to high-complexity studies in compliance with ICH GCP • Assume regional Lead CTM, Clinical Study Manager, process improvement, program management, or project coordination responsibilities as assigned • Develop clinical tools, monitoring plans, monitoring guidelines, and contribute to data quality and master action plans • Set up, organize, maintain, and archive relevant Trial Master File documents and study materials • Participate in developing CRFs, CRF guidelines, informed consent templates, and protocol-specific documents • Prepare, organize, and present at client meetings, including bid defense and hand-off meetings • Collaborate with clinical teams and other departments, lead team meetings, and 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, and ethics committee follow-up when applicable • Provide input to clinical activity forecasts • Manage clinical resources, delegate responsibilities, and identify additional resource requirements • Conduct accompanied field visits and manage project financials when required • Perform limited line management responsibilities on assigned GPHS projects in North America

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • 8+ years of previous experience providing the knowledge, skills, and abilities to perform the job • An equivalency combining appropriate education, training and/or directly related experience may be considered • Strong leadership, mentoring, training, planning, organizational, interpersonal, problem-solving, judgment, decision-making, escalation, risk management, financial, and attention-to-detail skills • Understanding of change management principles • Comprehensive understanding of clinical monitoring practices, processes, and requirements • Effective oral and written communication skills, including English language proficiency • 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 computerized applications • Ability to independently manage clinical-only studies • Willingness and ability to frequently drive to site locations and travel domestically and internationally

🏖️ Benefits

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

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