Clinical Study Operations Manager

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

📋 Description

• Collaborate with project teams to execute study startup tasks, which encompass communication planning, logistics, the creation of study documentation, and data configuration.

• Build client confidence in study operations through startup, ongoing maintenance, and closeout activities.

• Serve as the main point of contact for clinical sites, ensuring seamless operations and effective communication.

• Deliver training to research sites on the utilization of Beacon’s devices and study protocols, ensuring correct device operation and data collection.

• Oversee project progress, guaranteeing compliance with timelines, protocols, and quality standards.

• Uphold adherence to Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and regulatory requirements.

• Promote a culture of quality within the ClinOps and Scientific teams by mentoring peers on GCP standards, documentation practices, version control, and complaint resolution.

• Quickly address operational challenges, utilizing tools like Zendesk and Asana for effective resolution.

• Provide constructive feedback from research sites to guide enhancements in devices and workflows.

⛳️ Requirements

• Background in clinical project management or clinical operations roles.

• Strong organizational and project management abilities, capable of effectively managing multiple responsibilities.

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

• A proactive approach with the capacity to identify priorities and foresee potential 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 clinical research regulatory standards.

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

• Eagerness to expand knowledge in analytics, statistics, machine learning, and clinical trials.

🏝️ Benefits

• Equity

• PTO