Senior Clinical Team Manager – FSP

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🔥 18 minutes ago

🌲 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 studies, of moderate to high complexity, in compliance with ICH GCP. • Develop clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. • Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings. • Regularly communicate with the team and leads team meetings to ensure that timelines, resources, interactions, and quality are maintained. • Ensure achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics. • May routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials. • Communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues. • Provide input into preparation of forecast estimates for clinical activities. • Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years). • Strong planning and organizational skills to enable effective prioritization of workload and workload of team members • Strong interpersonal and problem solving skills to enable working in a multicultural matrix organization • Solid understanding of change management principles • Comprehensive understanding of the practices, processes, and requirements of clinical monitoring • Strong judgment, decision making, escalation, and risk management skills • Effective oral and written communication skills, including English language proficiency • Strong financial acumen and knowledge of budgeting, forecasting and fiscal management • Strong attention to detail • In-depth understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc. • Strong computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc. • Capable of independently managing clinical only studies.

🏖️ Benefits

• Flexible work arrangements • Professional development opportunities