Clinical Team Manager – HemOnc

🔥 2 hours ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

👔 Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 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, monitoring guidelines, data quality plans, and clinical sections of the Master Action Plan • Ensure timely setup, organization, content, and quality of local and central Trial Master File sections • Participate in designing CRFs, CRF guidelines, patient informed consent templates, and other 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 cross-functional teams to meet project deliverables • Lead team meetings and maintain timelines, resources, interactions, and quality • Implement and train teams on standardized clinical monitoring processes • Ensure timely archiving of documents and study materials • Prepare and monitor clinical activity timelines and metrics, provide project status updates, review projects using tracking tools, implement recovery actions, review monitoring visit reports, and manage CRF collection and query resolution • Monitor or co-monitor clinical trials to assess performance and meet 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 other study issues • Coordinate study start-up activities and ensure timely ethics committee and regulatory submissions • 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 experience in healthcare, nursing, medicine, or related disciplines may be considered in combination with clinical trial experience where the candidate demonstrates significant clinical expertise, therapeutic area knowledge, and direct patient care responsibilities • Must have FSO/CRO experience • Must have Global CTM experience managing global teams • Indication experience in one or more of: 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 • Familiarity with the practices, processes, and requirements of clinical monitoring • Solid understanding of relevant regulations, including ICH/GCP and FDA guidelines • Good computer skills using Outlook, Excel, Word, and similar computerized applications • Effective oral and written communication skills, including English language proficiency • Good leadership, planning, organizational, interpersonal, problem-solving, judgment, decision-making, financial, budgeting, forecasting, fiscal management, and attention-to-detail skills • Capable of working effectively in a changing environment with complex or ambiguous situations • Capable of evaluating workload against project budget and adjusting resources accordingly

🏖️ Benefits

• Collaboration and development opportunities • Global team environment • Frequent domestic and international travel opportunities