Clinical Trial Manager, FSP

🕒 3 days ago

🇲🇽 Mexico – 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, monitoring plans, monitoring guidelines, data quality plans, and clinical-related documents • Contribute to Master Action Plans and maintain the quality and organization of Trial Master Files • Participate in designing CRFs, CRF guidelines, informed consent templates, and other protocol-specific documents • Collaborate with project managers to prepare, organize, and present client meetings, including bid defense and hand-off meetings • Collaborate with clinical and cross-functional teams to meet project deliverables • Lead team meetings and maintain timelines, resources, interactions, and quality • Implement and train teams on standardized clinical monitoring processes • Archive study documents and materials in a timely manner • Prepare and monitor clinical activity timelines and metrics, provide project status updates, review tracking tools, and implement recovery actions • Review monitoring visit reports and manage CRF collection and query resolution • Monitor or co-monitor clinical trials to assess performance and meet contractual obligations • Conduct Accompanied Field Visits and manage project financials when required in smaller regions • Communicate with study sites about protocol, patient participation, case report forms, and related 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 • Manage clinical resources, delegate responsibilities, and identify 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 • Equivalent combination of appropriate education, training and/or directly related experience may be considered • Leadership, mentoring, training, motivation, and team integration skills • Planning and organizational skills • Interpersonal and problem-solving skills • Ability to work in a multicultural matrix organization and changing environment with complex/ambiguous situations • Familiarity with clinical monitoring practices, processes, and requirements • Judgment and decision-making skills • Effective oral and written communication skills, including English language proficiency • Ability to evaluate workload against project budget and adjust resources • Financial acumen and knowledge of budgeting, forecasting, and fiscal management • Strong attention to detail • Understanding of relevant regulations, including ICH/GCP and FDA guidelines • Computer skills using Outlook, Excel, Word, and similar applications • Ability to frequently drive to site locations and travel domestically and internationally

🏖️ Benefits

• Global team environment • Collaboration and development opportunities • Frequent domestic and international travel as part of the role

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