Clinical Study Operations Manager

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

📋 Description

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

• Foster client confidence in study operations through startup, maintenance, and close-out processes.

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

• Provide training for research sites on Beacon’s devices and study protocols.

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

• Uphold adherence to GCP, ICH guidelines, and regulatory standards.

• Mentor colleagues on GCP requirements, documentation discipline, version control, and complaint management.

• Tackle operational challenges and escalate them using Zendesk and Asana.

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

• Guarantee the effective operational execution of clinical studies from initiation to close-out.

⛳️ Requirements

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

• Strong organizational and project management abilities.

• Exceptional written and verbal communication skills in English.

• Proactive in identifying priorities and anticipating potential challenges.

• Keen attention to detail for precise data collection and reporting.

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

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

• Understanding of decentralized data collection, compliance, and oversight mechanisms.

• Empathetic approach towards patients and research sites.

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

🏝️ Benefits

• Contract-to-hire opportunity.

• Fully remote work available anywhere in the U.S.

• Asynchronous work practices.

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

• Equity options.

• Paid Time Off (PTO).

• Additional benefits included in the comprehensive compensation package.