Clinical Trial Manager – FSP

🔥 0 minutes ago

⚓ Rhode Island – Remote

⚓ Rhode Island – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

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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 all clinical operational and quality aspects of allocated low- to moderate-complexity studies in compliance with ICH GCP • Develop clinical tools, including Monitoring Plans and Monitoring Guidelines, with the Data Quality Plan • Contribute to the Master Action Plan for clinical-related documents • Ensure timely setup, organization, content, and quality of relevant Trial Master File sections • Participate in designing and developing CRFs, CRF guidelines, informed consent templates, and protocol-specific documents • Collaborate with the project manager to prepare, organize, and present client meetings, including bid defense and hand-off meetings • Collaborate with clinical and other departmental teams to meet project deliverables • Communicate regularly with the team and lead team meetings to maintain timelines, resources, interactions, and quality • Implement and train standardized clinical monitoring processes • Archive documents and study materials in a timely manner • Achieve final clinical deliverables within contractual timelines by monitoring activity timelines and metrics, providing status updates, reviewing projects, implementing recovery actions, reviewing monitoring visit reports, and managing 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 in smaller regions • Communicate with study sites about protocol, patient participation, case report forms, and study-related issues • Coordinate study start-up activities and ensure timely ethics committee and regulatory submissions • Ensure essential document quality meets Regulatory Compliance Review expectations • Review 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 comparable experience • Experience managing multiple studies and competing priorities simultaneously • Strong knowledge of Australia's study start-up process, regulatory submissions, and investigator site contracts and budgets • Familiarity with clinical monitoring practices, processes, and requirements • Understanding of relevant regulations, including ICH/GCP and FDA guidelines • English language proficiency • Effective oral and written communication skills • Good computer skills with Outlook, Excel, Word, and similar applications • Financial acumen and knowledge of budgeting, forecasting, and fiscal management • Planning, organizational, interpersonal, problem-solving, judgment, and decision-making skills • Ability to work effectively in a changing environment with complex or ambiguous situations • Oncology experience considered advantageous • Study start-up experience within Australia considered an asset

🏖️ Benefits

• Comprehensive benefits • Wellness programs • Employee Assistance Program providing confidential support for personal and work-related issues • Flexible arrangements • Generous leave policies • Option to purchase additional leave • Paid birthday leave • Company paid parental leave • Paid volunteer time • Online courses via Thermo Fisher Scientific University Plus and LinkedIn Learning • Workshops • Mentorship programs