Senior Clinical Team Manager – HemOnc

🔥 3 hours ago

🇰🇷 South Korea – Remote

⏰ Full Time

🟠 Senior

👔 Manager

👻 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

• Lead clinical operational and quality aspects of allocated moderate- to high-complexity studies in compliance with ICH GCP • Manage clinical aspects of trials from launch through closeout • Coordinate Clinical Management members allocated to projects on a regional or country basis • Partner with Project Managers to establish training, tracking, and quality systems • Own clinical deliverables within agreed timelines, budgets, and customer expectations • Develop monitoring plans, monitoring guidelines, data quality plans, and related clinical tools • Contribute to Master Action Plans and maintain relevant Trial Master File sections • Participate in developing CRFs, CRF guidelines, informed consent templates, and protocol-specific documents • Prepare, organize, and present at client, bid defense, and hand-off meetings • Lead clinical team meetings and collaborate cross-functionally to maintain timelines, resources, interactions, and quality • Implement and train teams on standardized clinical monitoring processes • Monitor clinical activity timelines, metrics, monitoring visit reports, CRF collection, query resolution, and recovery actions • Communicate with study sites regarding protocols, patient participation, case report forms, and study issues • Coordinate study start-up activities, regulatory submissions, and ethics committee follow-up when applicable • Provide clinical resource forecasts, assign and delegate responsibilities, and identify additional resource needs • Mentor and train junior staff • May assume regional Lead CTM, Clinical Study Manager, program leadership, process improvement, or project coordination responsibilities • May conduct Accompanied Field Visits and manage project financials

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • 8+ years of previous relevant experience • Minimum of 8 years in clinical research • Experience leading global clinical teams on hematology and oncology clinical trials • Experience in relevant therapeutic areas including ovarian, sickle cell, non-Hodgkins lymphoma, multiple myeloma, glioma, head and neck, pancreas, prostate, non-small cell lung, breast, colorectal, radiopharmaceutical, cell and gene therapy, and/or CART-T • Advanced degree or equivalent experience in life sciences, medicine, or a related field preferred • Strong leadership, mentoring, training, planning, organizational, interpersonal, problem-solving, judgment, decision-making, escalation, risk management, and financial skills • Comprehensive understanding of clinical monitoring practices, processes, and requirements • Understanding of change management principles • Knowledge of relevant regulations, including ICH/GCP and FDA guidelines • Effective oral and written communication skills, including English language proficiency • Strong computer skills using Outlook, Excel, Word, and similar applications • Ability to independently lead clinical-only studies • Ability to evaluate workload against project budgets and adjust resources • Ability to travel independently up to 20% • Ability to work in non-traditional work environments and use standard office equipment and technology

🏖️ Benefits

• Health and wellbeing support • Healthy and balanced work environment • Professional development through mentoring and training • Opportunities to participate in innovative global healthcare projects

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