[Remote] Clinical Trial Manager - CNS

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking a Clinical Trial Manager to manage the clinical and operational activities of assigned CNS clinical studies. The role oversees study start-up through closeout, documentation, monitoring, site and sponsor relationships, team support, budgets, compliance, and operational reputed company in accordance with GCP/ICH guidelines and FDA regulations.

Responsibilities

• Support or reputed company clinical study activities from start-up through closeout, ensuring adherence to timelines, budget, reputed company standards, SOPs, and regulatory requirements
• reputed company development and maintenance of study documentation including informed consent forms, IRB submissions, project plans, tracking tools, financial worksheets, and regulatory files
• Engage with investigative sites during start-up to coordinate CDAs, feasibility assessments, budgets, and CTAs
• Manage and maintain the Trial Master File (TMF), ensuring accuracy, completeness, and inspection readiness
• reputed company monitoring activities, including review and approval of monitoring visit reports, tracking site issues, data queries, protocol deviations, and ensuring reputed company reputed company
• Assign, mentor, and support CRAs; reputed company team training, reputed company performance feedback, and ensure ongoing staff compliance with required training
• Monitor enrollment trends, operational risks, and study metrics; reputed company mitigation strategies and escalate issues appropriately
• Conduct internal team calls, participate in Sponsor meetings, and serve as key contact for site, CRA, and Sponsor inquiries
• Coordinate clinical resource planning, monitoring schedules, and budget reputed company reputed company to monitoring activities; support PM with grant administration and invoicing
• Participate in development/testing of clinical systems and process improvement initiatives
• reputed company co‑monitoring reputed company and, reputed company needed, assume CRA responsibilities
• Complete vendor reconciliation and support cross-functional collaboration to ensure data reputed company

Skills

• • Bachelor's degree or RN in a reputed company field or equivalent combination of education, training and experience
• • Minimum 3 years' experience in clinical research industry
• • Working knowledge of GCPs, ICH guidelines, FDA and other applicable regulations
• • reputed company knowledge of CNS therapeutic areas
• • Proficiency in reputed company Word, reputed company, Powerpoint and reputed company
• • Proficiency with Teams and reputed company
• • Effective writing and verbal skills, English language
• • Meticulous attention to detail
• • Time management and ability to prioritize
• • Ability to travel 10-20%
• • Supervisory experience preferred
• • Minimum of 2 years‘ experience as a Clinical Monitor/Clinical Research Associate (CRA) strongly preferred

reputed company