Clinical Team Manager – HemOnc

🕒 September 18

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

👔 Manager

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👻 Ghost score 30%

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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 plan contributions, and Master Action Plan content • Ensure timely setup, organization, content, and quality of Trial Master File sections • Participate in designing CRFs, CRF guidelines, informed consent templates, and protocol-specific documents • Collaborate with project managers on client meetings, bid defense, and hand-off meetings • Collaborate with clinical and other departments to meet project deliverables • Lead team meetings and maintain timelines, resources, interactions, and quality • Implement and train standardized clinical monitoring processes • Ensure timely archiving of documents and study materials • Prepare and monitor clinical timelines and metrics, provide project status updates, review tracking tools, implement recovery actions, review monitoring visit reports, and manage CRF collection and query resolution • Monitor or co-monitor clinical trials and assess performance against contractual obligations • Conduct Accompanied Field Visits and manage project financials in smaller regions when applicable • Communicate with study sites regarding protocol, patient participation, case report forms, and study issues • Coordinate study start-up activities and ethics committee/regulatory submissions when appropriate • Ensure essential document quality and follow up on ethics committee questions • Provide input into clinical activity forecasts • Manage clinical resources, delegate 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 • FSO/CRO experience • Global CTM experience managing global teams • Indication experience in 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 CAR-T • Good leadership, mentoring, training, and team motivation 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/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 budget 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 similar automated systems/applications • Frequently drives to site locations and travels domestically and internationally

🏖️ Benefits

• Collaboration and development opportunities • Global team environment • Work in an environment valuing passion, innovation, and scientific excellence

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