Clinical Study Operations Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Ensure the effective operational execution of Beacon's clinical studies from initiation to closure.

• Collaborate with project teams on startup tasks, including communication strategies, logistics, study documentation, and data organization.

• Supervise the planning for study startups, site onboarding, training, and ongoing operational management.

• Serve as the main point of contact for clinical sites.

• Deliver training to research sites regarding Beacon's devices and study protocols.

• Monitor the progress of projects and ensure adherence to timelines, protocols, and quality standards.

• Uphold compliance with GCP, ICH guidelines, and regulatory requirements.

• Mentor colleagues on GCP standards, documentation practices, version control, and complaint resolution.

• Resolve operational challenges and escalate issues using tools like Zendesk and Asana.

• Gather feedback from research sites to enhance devices and workflows.

• Collaborate with sponsors, project teams, and clinical sites to identify risks and ensure stakeholder alignment.

⛳️ Requirements

• Over 5 years of experience in clinical project management or clinical operations positions.

• Strong organizational and project management abilities, with a capacity to handle multiple responsibilities efficiently.

• Exceptional written and verbal communication skills in English; proficiency in additional languages is advantageous.

• A proactive approach with the capability to recognize priorities and foresee challenges.

• Keen attention to detail, ensuring precision in data collection and reporting.

• Ability to thrive in a fast-paced environment with competing priorities.

• Familiarity with GCP, ICH guidelines, and regulatory requirements in clinical research.

• Understanding of decentralized data collection, compliance, and oversight, with empathy for both patients and sites.

• A strong desire to expand knowledge in analytics, statistics, machine learning, and clinical trials.

🏝️ Benefits

• Equity

• PTO

• Asynchronous work practices

• Fully remote work

• In-person office hubs available in Boston, New York, and Paris

• Up to 10% travel