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 sponsors, project teams, and research sites while ensuring timelines, quality, compliance, and effective communication. The role also provides site training, resolves operational issues, and coaches peers on clinical operations quality practices.
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
- Excellent written and verbal communication skills in English
- 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
- Additional languages are a bonus
- A desire to learn more about analytics, statistics, machine learning, and clinical trials
Benefits
- Fully remote anywhere in the U.S.
- Equity
- PTO
- Other benefits
Company Overview