Manager, Clinical Study Operations

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

📋 Description

• Assist in the onboarding and ramp-up processes for the Clinical Study Operations team.

• Convert strategic priorities into a structured roadmap for the department, encompassing initiative sequencing, process investments, and team development.

• Supervise ClinOps execution throughout feasibility, site initiation, enrollment, monitoring, and project closure.

• Alert leadership to risks and obstacles with clear trade-offs and potential solutions.

• Take ownership of ClinOps KPIs and objectives, monitor progress in Asana, and provide reports to leadership and cross-functional teams.

• Make decisions regarding issue classification and escalation, including differentiating between complaints and technical issues, and managing device reconciliation/invoicing matters.

• Spearhead domain-level ClinOps initiatives, focusing on process standardization, tool implementation, and enhancements in dashboards and reporting.

• Sustain and enhance ClinOps SOPs, work instructions, and CTMS practices.

• Represent ClinOps in business development discussions, feasibility assessments, and Investigator Meetings.

• Manage relationships with sponsors and CRO intermediaries; represent Beacon directly when escalated decisions necessitate alignment or approval.

• Collaborate with Product, Engineering, Life Sciences, Data Science, and Business Development to ensure trials remain on schedule and compliant.

⛳️ Requirements

• Over 6 years of experience in clinical trial operations within biotech, medtech, or pharmaceutical industries.

• A Bachelor's or advanced degree in a clinical or scientific discipline.

• 1-2+ years of direct people management experience, demonstrating a history of hiring, coaching, and performance evaluation.

• Willingness to travel up to 15% of the time for Investigator Meetings, sponsor interactions, and site visits.

• Proven ownership of the clinical trial lifecycle, including start-up, recruitment strategy, enrollment, monitoring, data cleaning, and closure.

• Familiarity with Good Clinical Practice (GCP), FDA, and global regulatory standards.

• Background in SOP development and Quality Management System (QMS) practices (Qualio or similar).

• Ability to quickly familiarize oneself with proprietary CTMS/eTMF tools; prior experience with specific tools is not a requirement.

• Experience collaborating with CROs and vendors: supporting selection, overseeing daily operations, and managing relationships.

• Excellent cross-functional communication abilities.

• Comfortable working asynchronously across time zones in a remote-first, distributed environment.

• A tendency towards simplicity — capable of implementing the appropriate level of process without introducing unnecessary complexity.

🏝️ Benefits

• Equity.

• Paid Time Off (PTO).

• Asynchronous work practices that foster a robust remote experience.

• In-person hubs located in Boston, New York, and Paris.

• A remote-first, distributed organization.