Local Clinical Trial Manager

🔥 16 minutes ago

🇵🇭 Philippines – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 12%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• Manage local clinical studies in the Philippines for a client • 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 master action plans • Ensure timely setup, organization, content, quality, and archiving of local and central Trial Master File sections • Participate in developing CRFs, CRF guidelines, patient informed consent templates, and protocol-specific documents • Collaborate with project managers and clinical teams; prepare, organize, and present at client, bid defense, and hand-off meetings • Lead team meetings and implement standardized clinical monitoring processes and training • Monitor clinical activity timelines and metrics, provide status updates, implement recovery actions, review monitoring visit reports, and manage CRF collection and query resolution • Monitor or co-monitor clinical trials and ensure contractual obligations are met • Conduct Accompanied Field Visits and manage project financials where applicable • Communicate with study sites regarding protocols, patient participation, case report forms, and other study issues • Coordinate study start-up activities and ethics committee and regulatory submissions • Review and follow up on ethics committee questions and ensure essential document quality • Provide input to clinical activity forecasts and manage clinical resources, assignments, delegation, and additional resource requirements • Deliver clean data from evaluable patients within contractual timelines while meeting time, quality, cost, and profitability expectations

🎯 Requirements

• Oncology experience is a must • 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 • Equivalency through a combination of appropriate education, training and/or directly related experience may be considered • Good leadership, mentoring, training, planning, organizational, interpersonal, problem-solving, judgment, decision-making, communication, and attention-to-detail skills • English language proficiency • Familiarity with clinical monitoring practices, processes, and requirements • Ability to evaluate workload against project budget and adjust resources • Financial acumen and knowledge of budgeting, forecasting, and fiscal management • Understanding of relevant regulations, including ICH/GCP and FDA guidelines • Computer skills using Outlook, Excel, Word, and other automated systems and computerized applications • Ability to work effectively in a changing environment with complex/ambiguous situations • Ability to work in a multicultural matrix organization • Frequent travel to domestic and international site locations

🏖️ Benefits

• Collaboration and development opportunities • Global team environment • Passion, innovation, and commitment to scientific excellence • Frequent domestic and international travel opportunities

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