Clinical Team Manager – HemOnc

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🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

👔 Manager

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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 all clinical operational and quality aspects of allocated low- to moderate-complexity studies in compliance with ICH GCP • Develop clinical tools and contribute to Data Quality Plans, Master Action Plans, Trial Master File organization, CRFs, informed consent templates, and protocol-specific documents • Collaborate with project managers to prepare, organize, and present client meetings, including bid defense and hand-off meetings • Collaborate with clinical and other departments, lead team meetings, and maintain project timelines, resources, interactions, and quality • Implement and train standardized clinical monitoring processes • Ensure timely archiving of study documents and materials • Achieve final clinical deliverables within contractual timelines by monitoring clinical activity timelines and metrics, providing status updates, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution • Continuously monitor or co-monitor clinical trials to assess performance and meet contractual obligations • Conduct Accompanied Field Visits in smaller regions when applicable and manage project financials • Communicate with study sites regarding protocol, patient participation, case report forms, and other study issues • Coordinate study start-up activities and ethics committee and regulatory submissions when appropriate • Ensure essential document quality meets Regulatory Compliance Review expectations and follow up on ethics committee questions • Provide input into clinical activity forecasts • Manage clinical resources, delegate clinical responsibilities, and identify additional resource requirements

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification • 5+ years of relevant experience in clinical research, including clinical trial operations, study management, clinical monitoring, or related clinical research activities • Transferable healthcare, nursing, medicine, or related-discipline experience may be considered in combination with clinical trial experience when significant clinical expertise, therapeutic-area knowledge, and direct patient-care responsibilities are demonstrated • FSO/CRO experience required • Global CTM experience managing global teams required • Experience in one or more listed indications: 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 • Leadership, mentoring, training, team motivation, and team integration skills • Planning and organizational skills for workload prioritization • Interpersonal and problem-solving skills in a multicultural matrix organization • Ability to work effectively in changing environments with complex or ambiguous situations • Familiarity with clinical monitoring practices, processes, and requirements • Judgment and decision-making skills • Effective oral and written communication skills, including English language proficiency • Ability to evaluate workload against project budgets and adjust resources • Financial acumen and knowledge of budgeting, forecasting, and fiscal management • Strong attention to detail • Understanding of relevant regulations, including ICH/GCP and FDA guidelines • Computer skills using Outlook, Excel, Word, and other automated/computerized applications • Frequent domestic and international travel and driving to site locations

🏖️ Benefits

• Collaboration and development as part of the everyday experience • Reasonable accommodation for individuals with disabilities during the application/interview process and employment • Equal opportunity employment