Note: The job is a remote job and is open to candidates in USA. Bayside Solutions is a staffing and solutions company seeking a Clinical Trial Manager for a W2 contract role. The position drives the operational execution of assigned clinical studies from start-up through closeout, managing study teams, CROs, vendors, timelines, budgets, risks, data review, and regulatory compliance.
Responsibilities
- Manage day-to-day operational execution of assigned clinical studies to achieve study milestones, quality expectations, and budget objectives
- May lead cross-functional study team activities and coordinate operational deliverables across internal stakeholders and external vendors
- Oversee CROs and study vendors to ensure timely delivery, issue resolution, quality performance, and compliance with study requirements
- Support study start-up activities, including feasibility assessments, country and site selection, vendor selection, system set-up, and user acceptance testing
- Develop and maintain study management plans, operational timelines, and study tracking tools to support effective trial execution
- Ensure inspection readiness and maintain Trial Master File documentation in compliance with ICH/GCP guidelines and company SOPs
- Monitor study progress, identify operational risks, and implement mitigation plans to address issues impacting quality, timelines, or budget
- Contribute to data review, data cleaning activities, and operational review of study outputs and clinical study documentation
- Prepare and review study-related materials, including training content, operational manuals, presentations, and status reports
- Review study invoices, support accrual tracking activities, and monitor study spend against approved budgets
Skills
- Typically requires a bachelor's degree in life sciences, nursing, health sciences, or a related field; advanced degree, RN, or PA credentials preferred
- Typically requires 5+ years of clinical research or pharmaceutical industry experience, including 2+ years of clinical trial management experience
- Working knowledge of ICH/GCP guidelines, FDA regulations, and clinical trial processes across study start-up, conduct, and closeout
- Demonstrated ability to manage multiple priorities, solve operational issues, and drive projects independently in a fast-paced environment
- Strong organizational, communication, and cross-functional collaboration skills
- Proficiency with clinical trial systems, study tracking tools, and vendor management processes
- Experience managing global or multi-site clinical studies within a sponsor or CRO environment
Benefits
- Remote role
- W2 contract
Company Overview