Clinical Trial Manager – FSP

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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

• Achieve the final clinical deliverable within the contractual time period • Manage clinical operational and quality aspects of allocated low- to moderate-complexity studies in compliance with ICH GCP • Assume Clinical Study Manager responsibilities on small or less complex projects when required • Develop clinical tools, including Monitoring Plans and Monitoring Guidelines, with the Data Quality Plan • Contribute to the Master Action Plan and maintain relevant Trial Master File sections • Participate in developing CRFs, CRF guidelines, informed consent templates, and protocol-specific documents • Prepare, organize, and present client meetings with the project manager • Collaborate with clinical teams and other departments to meet project deliverables • Lead team meetings and communicate timelines, resources, interactions, and quality expectations • Implement and train teams on standardized clinical monitoring processes • Archive documents and study materials in a timely manner • Monitor clinical activity timelines and metrics, provide project status updates, implement recovery actions, review monitoring visit reports, and manage CRF collection and query resolution • Continuously monitor or co-monitor clinical trials and assess performance against contractual obligations • Conduct Accompanied Field Visits and manage project financials in smaller regions when required • Communicate with study sites regarding protocols, patient participation, case report forms, and study issues • Coordinate study start-up activities and 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 • Oncology experience considered advantageous • Study start-up experience within Australia considered an asset • Experience managing multiple studies and competing priorities simultaneously • Strong knowledge of study start-up in Australia, including regulatory submissions and investigator site contracts and budgets • Leadership, mentoring, training, and team-integration capabilities • Planning, organizational, prioritization, interpersonal, and problem-solving skills • Familiarity with clinical monitoring practices, processes, and requirements • Effective oral and written communication skills • English language proficiency • Financial acumen and knowledge of budgeting, forecasting, and fiscal management • Understanding of relevant regulations, including ICH/GCP and FDA guidelines • Good computer skills with Outlook, Excel, Word, and computerized applications • Ability to work in changing environments with complex or ambiguous situations • Ability to evaluate workload against project budgets and adjust resources • Frequent domestic and international travel and driving to site locations

🏖️ Benefits

• Comprehensive health and wellbeing benefits • Wellness programs • Employee Assistance Program providing confidential support • Flexible work arrangements • Generous leave policies • Option to purchase additional leave • Paid birthday leave • Company paid parental leave • Paid volunteer time • Access to Thermo Fisher Scientific University Plus online courses • LinkedIn Learning • Workshops • Mentorship programs