Clinical Trial Manager – FSP

🔥 1 minute ago

🇧🇷 Brazil – 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 • Assume Clinical Study Manager responsibilities on small or less complex projects when required • Develop clinical tools, Monitoring Plans, Monitoring Guidelines, Data Quality Plans, and contribute to Master Action Plans • Ensure timely setup, organization, content, quality, and archiving of Trial Master File documents and study materials • Participate in designing CRFs, CRF guidelines, informed consent templates, and protocol-specific documents • Collaborate with project managers to prepare, organize, and present client meetings, including bid defense and hand-off meetings • Lead clinical team meetings and maintain timelines, resources, interactions, and quality • Implement and train teams on standardized clinical monitoring processes • Prepare and monitor clinical activity timelines and metrics, provide project status updates, review tracking tools, and implement recovery actions • 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 regarding 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 experience providing the knowledge, skills, and abilities to perform the job • Equivalency through a combination of appropriate education, training and/or directly related experience may be considered • Knowledge of clinical monitoring practices, processes, and requirements • Understanding of relevant regulations, including ICH/GCP and FDA guidelines • English language proficiency • Good computer skills, including Outlook, Excel, and Word • Leadership, mentoring, training, planning, organizational, interpersonal, problem-solving, judgment, communication, financial management, budgeting, forecasting, and attention-to-detail skills • Ability to work effectively in a changing environment with complex/ambiguous situations and multicultural matrix organizations • Ability to evaluate workload against project budget and adjust resources accordingly • Frequent domestic and international travel and driving to site locations

🏖️ Benefits

• Global team environment • Collaboration and development opportunities • Exposure to passion, innovation, and scientific excellence • Full-time employment