We are seeking an innovative and entrepreneurial Clinical Trial Manager who will be tasked with leading the successful planning, implementation, and execution of global clinical trials. Reporting directly to the Chief Medical Officer, you will bring strong collaboration, vendor management, and project management skills to this critical clinical operations role.
The role is based in Cambridge, MA and will have the flexibility to work remotely around business needs.
ROLE AND RESPONSIBILITIES:
• Manage clinical trials from start-up through close-out, safeguarding that all components of the trial deliverables are executed to specified quality standards
• Ensure clear internal communication, process documentation, and coordination of relevant work, including the identification of risks, establishment and monitoring of metrics, and that timelines are accurate and comprehensive
• Act as main point of contact for external vendors and foster effective communication with all internal and external stakeholders
• Contribute to the development and implementation of study-related documents such as protocol amendments, plans and tracking mechanisms
• Proactively manage and track the project scope and change orders while evaluating the site and study performance
• Monitor the status of clinical data collection and the progress of clinical activity to produce regular and ad hoc reports
• Oversee the resolution of data quality issues
• Performs all activities in compliance with applicable regulations
• Potential for travel to sites as required
• Additional duties and responsibilities as assigned
QUALIFICATIONS:
• Bachelor’s degree is required (ideally in life sciences, nursing, health field or similar)
• 5-10+ years of experience working in clinical operations with an early-stage biotech or similar organization is required
• Biologics and/or cell therapy experience is highly preferred
• Early-phase clinical trial experience, including IND/CTA submissions is required
• Strong knowledge of best practices in clinical operations methodologies, systems, and processes is required, including GCP/ICH and other applicable regulations/guidelines
• Highly effective interpersonal skills and the ability to influence without direct authority
• A diligent problem solver with strong analytical skills
• Demonstrated record of success in executing critical deliverables independently
• Extremely organized and detail-oriented with a passion for providing quality results
