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 completion.

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

• Assist in the startup, management, and closure of studies for clients.

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

• Provide training to research sites on Beacon’s devices and study procedures.

• Oversee project progress to ensure adherence to timelines, protocols, and quality metrics.

• Uphold compliance with GCP, ICH guidelines, and relevant regulatory standards.

• Mentor colleagues on GCP standards, documentation practices, versioning, and issue management.

• Tackle operational challenges and escalate issues through Zendesk and Asana.

• Offer site feedback to enhance devices and workflows.

⛳️ Requirements

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

• Strong organizational abilities and project management expertise.

• Exceptional written and verbal communication skills in English.

• Proficiency in additional languages is advantageous.

• Proactive approach with the capability to prioritize and foresee challenges.

• Keen attention to detail.

• Capacity to operate in a fast-paced environment with competing priorities.

• Understanding of GCP, ICH guidelines, and clinical research regulatory requirements.

• Familiarity with decentralized data collection, compliance, and oversight practices.

• Enthusiasm for expanding knowledge in analytics, statistics, machine learning, and clinical trials.

🏝️ Benefits

• Equity.

• Paid Time Off (PTO).

• Comprehensive asynchronous work practices.

• Fully remote work opportunities.

• Access to in-person office hubs located in Boston, New York, and Paris.

• Up to 10% travel.