Clinical Team Manager – Neuro

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Oversee the clinical operational and quality components of assigned low- to moderate-complexity studies while adhering to ICH GCP guidelines.

• Create clinical tools and assist in the development of the Data Quality Plan and Master Action Plan.

• Ensure the timely setup, organization, content accuracy, and quality of sections within the Trial Master File.

• Engage in the design of CRFs, CRF guidelines, informed consent templates, and protocol-specific documentation.

• Collaborate with project managers to prepare materials and deliver presentations during client meetings.

• Lead clinical teams and conduct meetings to uphold timelines, resource management, interactions, and quality standards.

• Implement and provide training on standardized clinical monitoring procedures.

• Ensure the prompt archiving of study-related documents and materials.

• Track clinical activity timelines and metrics, offer project status updates, execute recovery actions, review monitoring visit reports, and manage CRF collection and query resolution.

• Consistently monitor or co-monitor clinical trials to ensure compliance with contractual obligations.

• Conduct Accompanied Field Visits and oversee project finances in smaller regions as needed.

• Communicate with study sites regarding protocols, patient participation, case report forms, and associated issues.

• Organize study start-up activities and handle ethics committee and regulatory submissions when necessary.

• Review and address queries from ethics committees.

• Contribute to clinical activity forecasting.

• Manage clinical resources, assign responsibilities, and identify additional resource needs.

⛳️ Requirements

• Bachelor's degree or equivalent and relevant formal academic or vocational qualification.

• Over 5 years of pertinent experience in clinical research, encompassing clinical trial operations, study management, clinical monitoring, or similar activities.

• Consideration of transferable experience in healthcare, nursing, medicine, or related fields may be given, provided the candidate demonstrates significant clinical expertise, knowledge of therapeutic areas, and direct patient care responsibilities.

• Proven experience in end-to-end management of studies.

• Familiarity with clinical monitoring practices, processes, and requirements.

• Understanding of ICH/GCP, FDA guidelines, and applicable regulations.

• Proficiency in the English language.

• Competent in computer applications, including Outlook, Excel, and Word.

• Knowledge of budgeting, forecasting, and financial management.

• Capability to assess workload against project budgets and adjust resources as needed.

• Experience in Early Phase and Start-up phases is preferred.

• Preferred experience in the neurology therapeutic area.

🏝️ Benefits

• Global team environment.

• Opportunities for collaboration and professional development.

• Work environment focused on scientific excellence.