Local Clinical Trial Manager

🕒 October 7

🇵🇭 Philippines – 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, data quality plans, and contribute to master action plans • Set up, organize, maintain, and archive local and central Trial Master File documentation • Participate in designing CRFs, CRF guidelines, informed consent templates, and protocol-specific documents • Collaborate with project managers and clinical teams on client meetings, bid defense, hand-off meetings, deliverables, timelines, resources, and quality • Implement and train teams on standardized clinical monitoring processes • Monitor clinical activity timelines and metrics, provide 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 when appropriate • Review and follow up on ethics committee questions • Provide input into clinical activity forecasts and manage clinical resources, assignments, delegations, and additional resource requirements • Travel to domestic and international site locations as required

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • 5+ years of comparable experience • Oncology experience is a must • Leadership, mentoring, training, planning, organizational, interpersonal, problem-solving, judgment, and decision-making skills • Familiarity with clinical monitoring practices, processes, and requirements • English language proficiency • Knowledge of budgeting, forecasting, fiscal management, and project financials • Understanding of relevant regulations, including ICH/GCP and FDA guidelines • Computer skills with Outlook, Excel, Word, and similar applications • Ability to work effectively in a changing environment and multicultural matrix organization • Ability to evaluate workload against project budget and adjust resources accordingly • Willingness and ability to travel domestically and internationally and drive to site locations

🏖️ Benefits

• Global team environment • Collaboration and development opportunities • Exposure to innovation and scientific excellence

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