Senior Clinical Lead/ Senior Clinical Trial Manager

🕒 5 days 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 allocated moderate- to high-complexity studies in compliance with ICH GCP • Assume regional Lead CTM, Clinical Study Manager, process improvement, program management, management, or project coordination responsibilities as assigned • Develop clinical tools such as Monitoring Plans and Monitoring Guidelines with the Data Quality Plan • Contribute to the Master Action Plan and ensure timely setup, organization, content, and quality of Trial Master File sections • Participate in designing CRFs, CRF guidelines, informed consent templates, and other protocol-specific documents • Collaborate with project managers on client meetings, bid defense, and hand-off meetings • Coordinate clinical teams and departments, lead team meetings, and maintain timelines, resources, interactions, and quality • Implement and train standardized clinical monitoring processes • Ensure timely archiving of documents and study materials • Monitor clinical timelines, metrics, status, tracking tools, recovery actions, monitoring visit reports, CRF collection, and query resolution • Continuously assess trial performance and contractual obligations • Conduct Accompanied Field Visits and manage project financials as needed • Communicate with study sites regarding protocols, patient participation, case report forms, and study issues • Coordinate study start-up activities and regulatory submissions when appropriate • Review and follow up on ethics committee questions • Prepare clinical activity forecast estimates • Manage clinical resources, delegate responsibilities, and identify additional resource needs • May have 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 • English language proficiency • Strong leadership, mentoring, training, planning, organizational, interpersonal, problem-solving, judgment, decision-making, escalation, risk management, communication, and attention-to-detail skills • Understanding of change management principles • Comprehensive understanding of clinical monitoring practices, processes, and requirements • 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, 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 • Passion, innovation, and commitment to scientific excellence

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