Note: The job is a remote job and is open to candidates in USA. Beacon Biosignals is transforming precision medicine for the brain through at-home EEG and cardiopulmonary signal platforms for clinical development and diagnostics. The Clinical Study Operations Manager will oversee clinical study delivery from startup through close-out, coordinating with sponsors, project teams, and sites while ensuring quality, compliance, risk management, and operational efficiency.
Responsibilities
- Collaborate with project teams to implement study startup activities, including communication planning, logistics, development of study documentation, and data configuration
- Instill confidence with clients on study operations through start up, maintenance and close out activities
- Act as the primary point of contact for clinical sites, ensuring smooth operations and clear communication
- Provide training to research sites on the use of Beacon’s devices and study protocols, ensuring proper device usage and data collection
- Monitor project progress, ensuring adherence to timelines, protocols, and quality standards
- Maintain compliance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and regulatory standards
- Foster a culture of quality within the ClinOps and Scientific teams by coaching peers on GCP requirements, documentation discipline, versioning, and complaint management
- Address operational issues promptly, escalating through tools like Zendesk and Asana for resolution
- Provide actionable feedback from research sites to inform improvements in devices and workflows
Skills
- 5+ years of experience in clinical project management or clinical operations roles
- Strong organizational and project management skills, with the ability to manage multiple responsibilities effectively
- A proactive mindset with the ability to identify priorities and anticipate challenges
- Meticulous attention to detail, ensuring accuracy in data collection and reporting
- Ability to work in a fast paced environment with multiple priorities
- Familiarity with GCP, ICH guidelines, and clinical research regulatory requirements
- Knowledge of decentralized data collection, compliance and oversight while showing empathy for both patients and sites
- A desire to learn more about analytics, statistics, machine learning, and clinical trials
- Excellent written and verbal communication skills in English; additional languages are a bonus
Benefits
- Fully remote anywhere in the U.S.
- Equity
- PTO
Company Overview