Senior Clinical Trial Manager, FSP

🔥 0 minutes ago

🇧🇷 Brazil – 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 moderate- to high-complexity studies in compliance with ICH GCP • Develop clinical tools, monitoring plans, monitoring guidelines, data quality plans, master action plans, and Trial Master File sections • Participate in developing CRFs, CRF guidelines, informed consent templates, and protocol-specific documents • Prepare and present client meetings, including bid defense and hand-off meetings • Collaborate with clinical teams and other departments; lead team meetings and implement standardized monitoring processes and training • 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-related issues • Coordinate study start-up activities, regulatory submissions, and ethics committee follow-up when applicable • Provide input into clinical activity forecasts • Manage clinical resources, delegation of responsibilities, and additional resource requirements • May assume regional Lead CTM, Clinical Study Manager, process improvement, program management, project coordination, or limited line-management responsibilities

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • 8+ years of comparable experience • Equivalency may consist of appropriate education, training and/or directly related experience • Strong leadership, mentoring, training, motivation, and team integration skills • Strong planning, organizational, interpersonal, problem-solving, judgment, decision-making, escalation, and risk-management skills • Solid understanding of change-management principles • Comprehensive understanding of 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 with 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 • Commitment to scientific excellence

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