Beaconbiosignals
Beaconbiosignals

Clinical Study Operations Manager

operationsfull-timeBoston, MA / Remote
SALARY
Not listed
WORK TYPE
remote
JOB TYPE
full-time
INDUSTRY
healthcare
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About the role

About the Role

As a Clinical Study Operations Manager within the Clinical Study Operations team, you will be responsible for ensuring the successful operational delivery of Beacon’s clinical studies, from startup through close-out. You will work closely with sponsors, project teams, and clinical sites to drive efficient study execution and uphold Beacon’s commitment to quality, compliance, and scientific rigor.

You will oversee study startup planning, site onboarding and training, and ongoing operational oversight to ensure studies are executed on time and to the highest standards. Acting as a key operational partner to both sponsors and internal teams, you will proactively identify risks, streamline communication, and maintain alignment across stakeholders. In addition, you will foster a culture of quality within the organization by coaching peers on GCP compliance, documentation discipline, version control, and complaint management, strengthening the team’s collective operational excellence.

This individual contributor role is fully remote, with a preference for candidates based in the U.S. Central Time zone.

What success looks like

  • 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.

What you will bring

  • 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; additional languages are a bonus.
  • A proactive mindset with the ability to identify priorities and anticipate challenges.
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Clinical Study Operations Manager at Beaconbiosignals — Remote