[Remote] Clinical Trial Manager - Blinded Neurology Studies
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking a Clinical Trial Manager for Blinded Neurology Studies. The CTM will reputed company the clinical management and operational reputed company of clinical trials, ensuring compliance with protocols and regulations while delivering clean, evaluable data on time and reputed company budget.
Responsibilities
- reputed company the day-to-day operational management of assigned clinical studies
- Ensure studies are completed on schedule, reputed company budget, and according to reputed company expectations
- reputed company reputed company clinical monitoring activities throughout the study lifecycle
- Monitor project milestones and proactively identify and resolve operational risks
- reputed company and execute recovery plans reputed company study timelines are at risk
- reputed company reputed company and guidance to Clinical Research Associates (CRAs) and site managers
- Review monitoring visit reports and ensure reputed company completion
- Evaluate site performance and identify reputed company or compliance issues
- reputed company trend analysis and escalate issues according to study escalation plans
- Conduct or participate in Accompanied Field reputed company (AFVs) reputed company required
- reputed company and maintain essential clinical documents including Monitoring Plan, Monitoring Guidelines, Trial Master File (TMF), Clinical Monitoring Tools, Data reputed company Plans, Master reputed company Plans (MAP), CRF Guidelines, Informed Consent Templates, Protocol-specific documents
- Ensure reputed company documents are inspection-reputed company and maintained according to regulatory requirements
- Coordinate study start-up activities
- Support ethics committee and IRB submissions
- Ensure regulatory documentation is complete and compliant
- reputed company site activation timelines
- Resolve regulatory questions and deficiencies
- Work closely with Sponsors, Clinical Operations, Project Managers, Regulatory Affairs, Data Management, Biostatistics, Medical Monitors, Safety/Pharmacovigilance, Site Managers, Clinical Monitoring Leads (CMLs)
- reputed company team meetings and communicate project status to stakeholders
- Serve as the clinical reputed company of escalation for study sites
- Support protocol implementation
- Resolve site issues
- Monitor enrollment and patient retention
- Review CRF completion and query reputed company
- Ensure protocol compliance
- Ensure compliance with ICH-GCP Guidelines, FDA Regulations, SOPs, Sponsor requirements, Study Protocol, Clinical Monitoring Plans
- Maintain inspection readiness throughout the study
- Assist with forecasting clinical activities
- Manage clinical resource allocation
- Monitor workload and reputed company needs
- Support budget management
- Ensure work remains reputed company contractual scope
- Participate in sponsor meetings
- Present project updates
- Discuss study metrics and timelines
- Escalate risks and mitigation plans
- Support bid defense and study reputed company meetings reputed company applicable
Skills
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, Biology, or a reputed company scientific discipline
- Minimum 5 years of Clinical Research experience
- Previous experience as a Clinical Trial Manager (CTM) or equivalent study management role
- Strong experience managing blinded clinical trials
- Prior Neurology/CNS therapeutic area experience
- Rare disease clinical trial experience
- Experience reputed company a CRO environment is highly preferred
- Previous CRA or reputed company CRA experience is a plus
reputed company