Senior Clinical Team Manager – HemOnc

🔥 16 minutes 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 all clinical operational and quality aspects of allocated moderate- to high-complexity studies in compliance with ICH GCP • Implement and manage clinical aspects of trials from launch to closeout • Coordinate Clinical Management members allocated to projects on a regional or country basis • Partner with Project Managers on training, tracking, quality systems, timelines, budgets, and clinical deliverables • Act as the primary contact and support for project sponsors on clinical aspects • Develop clinical tools such as Monitoring Plans and Monitoring Guidelines • Contribute to Data Quality Plans and Master Action Plans • Set up, organize, maintain, and quality-check Trial Master File sections • Participate in designing CRFs, CRF guidelines, informed consent templates, and protocol-specific documents • Prepare, organize, and present at client, bid defense, and hand-off meetings • Collaborate with clinical and cross-functional teams to meet project deliverables • Lead team meetings and implement standardized clinical monitoring processes and training • Monitor clinical activity timelines, metrics, project performance, contractual obligations, and financials • Implement recovery actions, review monitoring visit reports, and lead CRF collection and query resolution • Communicate with study sites about protocols, patient participation, CRF completion, and study issues • Coordinate start-up activities and regulatory submissions when appropriate • Review and follow up on ethics committee questions • Provide clinical activity forecast estimates and manage clinical resources, assignments, and delegation • Mentor and train junior staff • Support process improvements, complex programs, regional leadership, Clinical Study Manager responsibilities, and project coordination as needed

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • 8+ years of previous experience providing the knowledge, skills, and abilities to perform the job • Minimum of 8 years in clinical research • Track record of leading global clinical teams on hematology and oncology clinical trials • Equivalent combination of appropriate education, training and/or directly related experience may be considered • Advanced degree or equivalent experience in life sciences, medicine, or a related field preferred • Experience in preferred hematology and oncology therapeutic areas and indications • Strong leadership, mentoring, training, planning, organizational, interpersonal, problem-solving, judgment, decision-making, escalation, risk management, and communication skills • English language proficiency • Strong financial competence and knowledge of budgeting, forecasting and fiscal management • In-depth understanding of relevant regulations, including ICH/GCP and FDA guidelines • Comprehensive understanding of clinical monitoring practices, processes, and requirements • Strong computer skills using Outlook, Excel, Word, and computerized applications • Ability to independently lead clinical-only studies • Ability to communicate and understand information with diverse groups • Ability to work upright and stationary for typical working hours • Ability to work in non-traditional work environments • Ability to use and learn standard office equipment and technology • Ability to perform under pressure while prioritizing and handling multiple projects or activities • Ability to travel independently up to 20% by automobile, airplane, and train

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule • Health and wellbeing support • Healthy and balanced work environment • Opportunities to work on innovative projects shaping global healthcare • Mentoring and training opportunities • Global and multicultural team collaboration

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