Senior Non-Interventional Studies Clinical Team Manager

🔥 0 minutes ago

🇧🇷 Brazil – Remote

⏰ Full Time

🟠 Senior

👔 Manager

👻 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 • Assume Lead CTM, Clinical Study Manager, process improvement, program management, management, or project coordination responsibilities as assigned • Develop clinical tools, monitoring plans, guidelines, data quality plans, and master action plans • Ensure timely setup, organization, content, quality, and archiving of Trial Master File documents and study materials • Participate in development of CRFs, CRF guidelines, informed consent templates, and protocol-specific documents • Collaborate with project managers to prepare and present client meetings, including bid defense and hand-off meetings • Lead clinical team meetings and coordinate departments to maintain timelines, resources, interactions, and quality • Implement and train teams on standardized clinical monitoring processes • Monitor clinical activity timelines, metrics, project status, recovery actions, monitoring visit reports, CRF collection, query resolution, trial performance, and contractual obligations • 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 into clinical activity forecasts • Manage clinical resources, delegation, assignment of responsibilities, and additional resource requirements • Conduct accompanied field visits and manage project financials when applicable • In assigned North American GPHS projects, undertake limited line management responsibilities when applicable

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • 8+ years of previous experience, or equivalent combination of education, training, and/or directly related experience • Strong leadership, mentoring, training, planning, organizational, interpersonal, problem-solving, judgment, decision-making, escalation, risk management, and attention-to-detail skills • Strong understanding of change management principles • Comprehensive understanding of clinical monitoring practices, processes, and requirements • Strong 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, including Outlook, Excel, Word, and computerized applications • Ability to independently manage clinical-only studies • Ability to work in a multicultural matrix organization • Ability to evaluate workload against project budgets and adjust resources accordingly

🏖️ Benefits

• Global team environment • Collaboration and development opportunities • Passion, innovation, and commitment to scientific excellence