Director of Clinical Operations

Director of Clinical Operations at ClinLab Solutions Group Director of Clinical Operations at ClinLab Solutions Group in Mount Vernon, New York Posted in 3 days ago.

Type:

full-time

Job Description:

Director of Clinical Operations

ABOUT THE ROLE

We are partnering with a growing clinical research site in the Bronx to recruit a Senior Director of Clinical Operations•the operational beast who will own site performance end-to-end. This is the go-to person who runs the site. Trial activation timelines, enrollment performance, study quality, regulatory compliance, financial operations, and the coordinator and research nursing teams all roll up to this seat. The right candidate has lived this work at a research site or site network before•they already know what good looks like, what breaks, and how to fix it without a 90-day diagnostic. This is an onsite role in the Bronx. Five days a week, in the building with the team, the patients, the PIs, and the studies. The site needs presence and operational leadership in the room.

WHAT YOU'LL OWN

End-to-end site performance: trial activation timelines, enrollment to target, retention, data quality, regulatory compliance, and financial outcomes per study Direct leadership of clinical operations staff, including CRCs, research nurses, regulatory and data coordinators, and operations support Operational accountability across the full study lifecycle: feasibility input, site activation, enrollment ramp, conduct, monitoring response, database lock, and close-out Sponsor and CRO relationships at the operational level•site qualification visits, monitoring visits, audit response, and corrective action planning Standardization of SOPs, training programs, quality systems, and operational metrics across the site Budget management at the study level: per-protocol P&L oversight, invoicing accuracy, and study-level margin discipline Hiring, onboarding, performance management, and retention of clinical operations staff Direct partnership with site leadership and PIs on prioritization, capacity planning, and study mix decisions

WHAT WE'RE LOOKING FOR

Required 10+ years of clinical research operations experience, with at least 5 years in a senior operational role at a clinical research site, multi-site network, SMO, or IRO Demonstrated track record of owning site performance metrics•enrollment, retention, activation timelines, quality, and study-level financials Direct experience managing CRC, research RN, regulatory, and data coordination teams Deep working knowledge of

GCP, FDA

regulations, sponsor and CRO operational expectations, and audit readiness Strong financial acumen at the study level•feasibility budgeting, invoicing, monitoring of study P&L Experience standing up or scaling SOPs, training programs, and operational quality systems at a site Bachelor's degree required; advanced degree, RN/BSN, or relevant certification (CCRC, CCRP, ACRP-CP) preferred Strongly Preferred VP or Director-level experience at a comparable research site network or SMO Track record running multi-therapeutic-area sites with diverse sponsor and CRO portfolios Prior experience in fast-growing or PE-backed clinical research environments Hands-on experience with CTMS, eRegulatory, EDC, and patient recruitment platforms Non-Negotiables Onsite five days a week in the Bronx. This is not a hybrid or remote role. Site-side or site-network operational experience. Pure CRO operations, pharma operations, or academic medical center operations backgrounds will not fit this role. A demonstrated bias toward operational ownership and execution•this is a doer's seat, not a strategist's seat.