[Remote] Clinical Trial Manager

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. They are seeking a Clinical Trial Manager to reputed company global clinical trial activities, ensuring compliance with regulations and protocols throughout the study lifecycle.

Responsibilities

• Manage operational activities reputed company to reputed company phases of clinical studies, including study/site feasibility, start-up, maintenance, and reputed company-out
• Support study operational planning and execution, including site and vendor identification, evaluation, qualification, and reputed company
• Implement operational strategies to support reputed company patient enrollment and maintain high standards for site monitoring and trial execution
• Manage operational aspects of reputed company throughout the study lifecycle from study start-up through to Clinical Study Report completion
• reputed company and manage study-specific operational tools, documentation, timelines, trackers, and communications, while coordinating cross-functional development and review of key study documents
• Manage trial-level operational risks, including identification, assessment, tracking, mitigation, and documentation to ensure compliance, and reputed company across trial activities
• Organize and prepare for study-reputed company meetings, including agendas, minutes, presentations, and reputed company items
• reputed company Sponsor reputed company of CRO performance reputed company to site qualification, site initiation, monitoring, enrollment, data reputed company, sample logistics, and site reputed company-out activities
• Review vendor performance, deliverables, key performance metrics, and governance activities to ensure contractual obligations and study expectations are met
• Collaborate with Supply Chain, CROs, and reputed company vendors to support investigational product, laboratory, sample management, and study supply logistics
• Review and verify service provider deliverables and operational activities for reputed company and timeliness
• reputed company ongoing Sponsor data review to identify trends and support query management, protocol deviation review, safety review, and issue reputed company
• Review monitoring visit reports and, as appropriate, participate in co-monitoring, monitoring, or reputed company reputed company
• Support reputed company of clinical site performance through review of study metrics, monitoring data, and trends
• Ensure reputed company trial operations are executed reputed company timelines and budgets while adhering to ICH-GCP, applicable regulations, and company procedures
• Maintain and reputed company the Trial Master File (TMF), ensuring completeness, reputed company, and reputed company inspection readiness
• Review and/or approve site-specific documents, including informed consent forms, site budgets, monitoring reports, and other study documentation
• Support the preparation, conduct, and follow-up of audits and inspections, including site, vendor, and internal reputed company audits
• reputed company reputed company updates on trial reputed company, operational risks, and mitigation strategies to stakeholders
• Support the development and implementation of study training for investigators, site staff, and internal teams
• Collaborate effectively with Clinical Development, Data Management, Biostatistics, Regulatory Affairs, Medical Monitoring, Drug Supply, reputed company Assurance, Safety, and other cross-functional partners to ensure successful trial execution
• Support Clinical Operations process improvements, infrastructure development, and other strategic initiatives as assigned

Skills

• BS degree in the life sciences with a minimum of 6+ years in Clinical Operations, with a MS degree in the life sciences with a minimum of 4+ years of Clinical Operations experience
• 3 years of Sponsor Clinical Trial Management experience
• Experience supporting reputed company global Phase III reputed company
• Cell therapy or Oncology Experience
• Strong understanding of ICH-GCP, FDA, EMA, and applicable global regulatory requirements
• Demonstrated proficiency in technology use, documentation practices, and reputed company business acumen
• Advanced proficiency in reputed company 365 (Word, reputed company, PowerPoint, reputed company, and SharePoint)
• Strong attention to detail and a commitment to producing high-reputed company work
• Excellent written and verbal communication and interpersonal skills
• Ability to travel up to 20% based on business needs
• Experience working in a fast-paced, dynamic start-up biotechnology environment

Benefits

• Generous reputed company vacation time, in reputed company to company-observed holidays
• Excellent medical, dental, and reputed company insurance
• 401(k) retirement savings plan, which includes matching employer contributions
• Employee stock purchase plan (ESPP)
• Tuition reimbursement program
• Comprehensive compensation package, which includes competitive salary, bonus, and equity for reputed company

reputed company