Cynosure Staffing · 17 hours ago
Senior Clinical Trial Manager/Clinical Data Operations Lead
San Diego, CA
Contract
Hybrid
Senior Level, Lead/Staff
10+ years expCynosure Staffing is a late-stage autoimmune company focused on developing and commercializing small molecule therapies. The Senior Clinical Trial Manager/Clinical Data Operations Lead serves as the operational owner for all clinical data activities within Phase 3 trials, ensuring data quality, compliance, and timely delivery of study milestones.
Staffing & Recruiting
Hiring Manager
Becky Krage
Responsibilities
Drive execution of the Clinical Data Strategy within the broader Clinical Operations plan
Ensure alignment between data deliverables and clinical timelines (e.g., interim analyses, database lock)
Monitor CRO performance and escalate issues impacting data quality or timelines to Clinical Operation Leads
Perform holistic data reviews in EDC and other vendor systems (e.g., eCOA, IRT, lab portals) to: Verify compliance with the protocol and GCP
Identify trends, inconsistencies, and potential risks across datasets
Ensure oversight of timely resolution of queries and reconciliation of safety and lab data
Document findings
Review operational and site-level data trends during blinded data review rounds
Communicate recurring issues or trends to Data Management (DM) and Biostatistics for validation and impact assessment
Share findings to internal Clinical Operations team to share in CRA calls and site communications for operational follow-up
Collaborate closely with the Medical Lead to review findings from data checks and ensure: Medical oversight of safety signals and protocol deviations
Alignment on corrective actions and escalation of clinically significant issues
Work closely with Clinical Operations Study Leads and Internal Lead CRA when trends require: Site or CRA retraining
Operational corrective actions to maintain compliance and data quality
Escalations to management if risks to deliverables and or study milestones are identified
Provide actionable insights and recommendations based on data trends
Engage with Quality Assurance (QA) before implementing any strategies or corrective actions based on data trends identified during reviews
Ensure QA input on compliance, risk mitigation, and documentation requirements
Align on timing of data cuts and ensure external data transfers are available for review
Work with DM to track findings, maintain visibility through trackers, and ensure timely resolution
Collaborate on root cause analysis for data discrepancies and protocol compliance issues
Engage Biostatistics to assess aggregate data for outliers, trends, and protocol compliance
Review dry-run tables, figures, and listings before database lock to confirm data readiness
Provide input on corrective actions that may affect statistical outputs or analysis datasets
When trends indicate systemic issues, coordinate with DM and Biostats to define corrective actions
Ensure these actions are documented and communicated to Clinical Operations for site or CRA retraining
Summarize key data trends and corrective actions for inclusion in: Study newsletters, Drug dev blasts, Other internal communication tools to ensure timely dissemination of information to sites and CRAs
Oversee CRO adherence to contractual obligations and KPIs for data-related activities
Maintain documentation demonstrating sponsor oversight of CRO data activities
Implement risk-based oversight strategies for data processes impacting patient safety and trial integrity
Participate in risk assessments and mitigation planning for operational data risks
Qualification
Required
Bachelor's degree in Life Sciences or related field
Minimum 10+ years in Clinical Operations, with strong exposure to data oversight in late-phase trials
Proven experience managing CROs and vendors in global Phase 3 studies
Deep understanding of clinical trial processes, ICH-GCP, and regulatory requirements
Strong leadership, communication, and problem-solving skills
Familiarity with EDC systems and vendor data flows
Preferred
advanced degree preferred
Company
Cynosure Staffing
A boutique recruitment firm specializing in cell and gene therapy recruitment for both retained and contingent searches across the US, from stealth-mode start-ups to global biotechs.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase