Clinical Trial Manager

🔥 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 • Develop clinical tools and contribute to Data Quality Plans and Master Action Plans • Ensure timely setup, organization, content, and quality of Trial Master File sections • Participate in designing CRFs, CRF guidelines, informed consent templates, and protocol-specific documents • Collaborate with project managers on client meetings, bid defenses, and hand-off meetings • Collaborate with clinical teams and departments to maintain timelines, resources, interactions, and quality • Lead team meetings and implement and train standardized clinical monitoring processes • Archive documents and study materials in a timely manner • Prepare and monitor clinical timelines and metrics, provide project status updates, and implement recovery actions • Review monitoring visit reports, manage CRF collection and query resolution, and monitor/co-monitor clinical trials • Conduct Accompanied Field Visits and manage project financials in smaller regions when applicable • Communicate with study sites regarding protocols, patient participation, case report forms, and other study issues • Coordinate study start-up activities and ethics committee and regulatory submissions when applicable • Ensure essential document quality and follow up on ethics committee questions • Provide input to clinical activity forecasts and manage clinical resources, assignments, delegations, and additional resource needs

🎯 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 may consist of a combination of appropriate education, training and/or directly related experience • Good leadership, mentoring, training, planning, organizational, interpersonal, problem-solving, judgment, and decision-making skills • 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 accordingly • Financial acumen and knowledge of budgeting, forecasting, and fiscal management • Strong attention to detail • Understanding of relevant regulations, including ICH/GCP and FDA guidelines • Good computer skills using Outlook, Excel, Word, and similar automated systems • Ability to work effectively in a changing environment with complex/ambiguous situations • Ability to work in a multicultural matrix organization

🏖️ Benefits

• Global team environment • Collaboration and development opportunities • Exposure to passion, innovation, and scientific excellence

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