Clinical Team Manager – Neuro

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

📋 Description

• Oversee all clinical operational and quality elements of assigned studies, which are of low to moderate complexity, adhering to ICH GCP standards.

• Create clinical tools (such as Monitoring Plans and Monitoring Guidelines) in collaboration with the Data Quality Plan.

• Work alongside the project manager to prepare, organize, and deliver presentations at client meetings, including bid defense and hand-off sessions.

• Ensure the completion of the final clinical deliverable within the agreed contractual timeline by preparing and tracking clinical activity schedules and metrics.

• Maintain regular communication with the team and lead team meetings to guarantee that timelines, resources, interactions, and quality are upheld.

• Ensure the prompt archiving of documents and study materials for the department.

• May engage with study sites regarding matters such as protocols, patient involvement, case report form completion, and other study-related concerns.

• Coordinate all start-up activities and ensure timely submissions to ethics committees and regulatory bodies.

⛳️ Requirements

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

• Prior experience that equips you with the knowledge, skills, and abilities necessary for the role (equivalent to 5+ years).

• Seeking Clinical Trial Managers (CTMs) with experience in comprehensive study management.

• Preference for candidates with Early Phase and Start-up experience.

• Therapeutic experience in Neurology preferred: Ophthalmology (General ophthalmology, Diabetic Macular Edema & Geographic Atrophy) and Rare Diseases (Myasthenia Gravis, Huntington's disease, ALS, DMD, CIDP, DM1 - myotonic dystrophy, and FSHD) - CAR-T experience is an advantage. Also, experience in Sleep, Epilepsy, and/or Psychiatry (Depression & Schizophrenia) is desirable.

🏝️ Benefits

• Health insurance

• 401(k) matching

• Flexible work hours

• Paid time off

• Remote work options