Clinical Team Manager – Neuro

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🔥 1 hour 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

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

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 low to moderate 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. • Ensure achievement of the final clinical deliverable within the contractual time period by preparing and monitoring clinical activity timelines and metrics. • Regularly communicate with the team and lead team meetings to ensure that timelines, resources, interactions, and quality are maintained. • Ensure timely archiving of documents and study materials for the department. • May communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues. • Coordinate all start-up activities and ensure that timely ethics committee and regulatory submissions are addressed.

🎯 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 5+ years). • Looking for CTMs with experience in end-to-end study management of studies. • Early Phase and Start-up experience preferred. • Therapeutic experience (Neurology) preferred: Ophthalmology: General ophthalmology, Diabetic Macular Edema & Geographic Atrophy Rare Disease: Myasthenia Gravis, Huntington's, ALS, DMD, CIDP, DM1 (myotonic dystrophy) and FSHD - CAR-T experience a plus Sleep, Epilepsy, and/or Psychiatry (Depression & Schizophrenia)

🏖️ Benefits

• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Remote work options