Clinical Program Operations Manager, Therapeutics & Innovation

POSITION SUMMARY

Join Natera 's Clinical Innovation & Therapeutics team as a Clinical Program Operations Manager. You will be responsible for the operational delivery of the team's oncology trials, including timelines, budgets, vendor performance, site management, and data flow, ensuring that studies are executed on schedule, within scope, and in a continuous state of inspection readiness.

This position is accountable for translating approved protocols into activated sites, enrolled patients, and clean, lockable data. You will work in close partnership with the team's field-based Medical Science Liaison, who leads scientific exchange and investigator engagement, the Head of Clinical Development and Medical Affairs, while you drive vendor oversight, and cross-functional accountability.
PRIMARY RESPONSIBILITIES
Program Execution and Timeline Management

- Develop and maintain the integrated study timeline, critical path, and Gantt chart from study startup through database lock, and hold internal functions and vendors accountable to committed dates

- Establish and maintain the dashboards, trackers, milestone reports, and risk and issue logs that provide leadership and the steering committee with accurate, current program status

- Identify risks early, drive mitigation plans to closure, and escalate issues to leadership with a recommended course of action

- Develop enrollment forecasts and manage cross-functional dependencies across Regulatory, Quality, Data Management, Biostatistics, Laboratory Operations, and Medical Affairs

Study Startup and Site Operations

- Lead feasibility and site selection end to end, including questionnaire development, site scoring, selection recommendations, and activation planning

- Manage site contracts and budgets, confidentiality agreements, essential document collection, IRB/EC submissions, and green-light criteria through site initiation

- Monitor and manage site performance against operational metrics, including enrollment versus target, screen failure rates, protocol deviations, query aging, and site payments, and implement corrective action plans for underperforming sites

- Refer scientific, protocol interpretation, and referral network matters to the Medical Science Liaison and Head of Clinical Development

Vendor and CRO Management

- Manage CRO and vendor selection, scopes of work, contracts, change orders, invoicing, and accruals

- Govern vendor performance against defined KPIs and service level agreements, lead governance meetings, and initiate corrective action when deliverables are at risk

- Coordinate central laboratory, IRT, EDC, eCOA, imaging vendors, and clinical supply and logistics

Budget and Resource Oversight

- Manage study budgets and resource plans, track forecast versus actual spend, and maintain accruals

- Identify variances early and present leadership with options and the associated cost and schedule trade-offs

Quality, Compliance, and Documentation

- Maintain trial master file completeness and inspection readiness on an ongoing basis

- Partner with Quality Assurance on deviations, CAPAs, audits, and inspection preparation

- Ensure study conduct is compliant with ICH-GCP, applicable regulations, and internal SOPs, and coordinate the operational elements of safety reporting with Pharmacovigilance

- Develop and maintain standardized project management templates, working practices, and operating cadences that support consistent execution across studies

Meeting and Data Review Operations

- Lead operational readiness and logistics for investigator meetings, site initiation visits, monitoring visits, steering committee meetings, and data review meetings, including agendas, materials preparation, and tracking of action items to closure

- Manage data cleaning timelines, query resolution, and database lock readiness so that scientific review proceeds on schedule

- Translate protocol and clinical objectives into executable operational plans, mo