Clinical Trial Manager
Company: Bold Steps Behavioral Health
- Location: Princeton, United States
- Employment type: Full-time
- Posted: 9 days ago
- Offer language: English
Job description
Role: Senior Clinical Trial Manager (CTM)
Responsibilities Include
- Leading the operational planning, setup, and execution of global clinical trials ensuring timely delivery and compliance with regulatory and quality standards.
- Managing trial documentation, systems, and site feasibility, selection, and activation strategies in collaboration with CROs and stakeholders.
- Overseeing CROs and service providers to ensure high-quality deliverables, adherence to timelines, and effective collaboration.
- Proactively identifying, assessing, and mitigating operational risks using risk-based quality management approaches.
- Monitoring trial performance and data quality through key metrics to inform decision-making and continuous improvement.
- Addressing protocol deviations and trial-level challenges with appropriate escalation and resolution.
- Fostering strong cross-functional collaboration across internal teams, vendors, and investigators.
Qualifications & Skills
- Bachelor’s degree in life sciences or related field; Master’s preferred.
- 8+ years of clinical trial management experience in the pharmaceutical or biotech industry.
- Deep understanding of ICH/GCP regulations and clinical development lifecycle.
- Experience managing global, multi-center trials within complex, matrixed organizations.
- Strong project management, communication, and interpersonal skills.
- Oncology or therapeutic area experience is highly desirable.
- Ability to lead without authority and mentor cross-functional teams.
