Manager, Clinical Study Operations

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

📋 Description

• Lead and oversee a team within Clinical Study Operations.

• Manage comprehensive ClinOps execution for clinical studies, covering feasibility, site initiation, recruitment, enrollment, data gathering, monitoring, and close-out processes.

• Establish expectations, mentor daily operations, escalate risks, and step in during complex or critical situations.

• Drive domain-level ClinOps objectives and initiatives, focusing on process standardization, tools, data quality, and enhancements to dashboards and reports.

• Convert strategic priorities into actionable roadmaps for the team's domain and effectively communicate these to stakeholders.

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

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

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

• Represent ClinOps in business development discussions, feasibility assessments, Investigator Meetings, deal structuring, SOW inputs, and site/study planning.

• Cultivate working relationships with sponsors and CRO intermediaries.

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

• Assist in onboarding and ramping up the team as it expands.

• Report directly to the Director of Clinical Study Operations.

⛳️ Requirements

• A minimum of 6 years of experience in clinical trial operations within biotech, medtech, or pharmaceutical sectors.

• Experience with device-based trials is a significant advantage.

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

• 1–2 years of direct people management experience, including hiring, coaching, and managing performance.

• Willingness to travel up to 15% of the time.

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

• Familiarity with GCP, FDA, and global regulatory standards.

• Experience in developing SOPs and QMS practices (such as Qualio or similar).

• Ability to quickly adapt to proprietary CTMS/eTMF tools.

• Experience in collaborating with CROs and vendors.

• Excellent cross-functional communication abilities.

• Capability to work asynchronously across time zones in a remote-first, distributed organization.

• Preference for simplicity and effective process design.

🏝️ Benefits

• Equity.

• Paid Time Off (PTO).

• Remote-first asynchronous work practices.

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

• A diverse and collaborative work environment.