Senior Clinical Research Associate / Clinical Trial Manager
B
BridgeBioBiopharmaceutical clinical research
Location: Remote - USA; This is a U.S.-based remote roleFull-TimeManager
Salary$145,000 — $177,000 USD
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Job Details
- Experience
- Minimum 4-6 years of clinical study experience
- Required Skills
- Microsoft ExcelPowerPoint
Requirements
- Hold a bachelor’s degree or equivalent training and experience in a scientific or medical field.
- Have a minimum of 4-6 years of clinical study experience.
- Bring experience supporting global studies in a fast-paced environment.
- Have Clinical Operations vendor management experience, including working with CROs and vendors.
- Have working knowledge of ICH E6(R3) Good Clinical Practice principles and risk-based quality management.
- Have experience using Microsoft Office Suite, including Excel, Word, and PowerPoint, and SmartSheet.
- Be able to achieve milestones in a team environment and collaborate respectfully in a remote environment.
- Be able to build and maintain working relationships with the department, cross-functional teams, clinical sites, vendors, and CROs.
Responsibilities
- Support clinical studies from planning and start-up through execution, maintenance, and close-out in accordance with SOPs, ICH/GCP, and corporate and departmental goals.
- Lead operational management for assigned regions and sites, including site initiation, performance metrics, risk mitigation, escalations, and action-item closure.
- Manage CRO and other key vendor deliverables and performance measures, address gaps, and drive corrective actions to closure.
- Oversee CRO monitors by reviewing monitoring documentation, evaluating monitor and site performance, and conducting oversight or co-monitoring visits as needed.
- Contribute to study documents, including informed consent forms, site training materials, CRFs, monitoring plans, protocols, and regulatory submission materials.
- Keep the Trial Master File complete, current, accurate, and inspection-ready, and resolve missing or deficient documentation.
- Apply ICH E6(R3) GCP principles, including quality by design, risk-proportionate oversight, critical-to-quality factors, participant protection, and reliable trial results.
- Review and negotiate site budgets and contracts, and support Investigator Meetings and other study-related meetings.
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