Clinical Program Operations Manager, Therapeutics & Innovation

Natera
United States
Workplace: RemoteFull timeUSD 116,200 - 145,200 annuallyFunction: Business OperationsEducation: bachelorsSkills: ["Independent ownership","Proactive problem-solving","Cross-functional alignment","Data-driven decision-making","Clear communication"]

Own end-to-end operational delivery for oncology clinical trials, from startup through database lock. Build and maintain integrated timelines, dashboards, and risk logs; drive enrollment forecasts and cross-functional execution across Regulatory, Quality, Data Management, Biostatistics, Laboratory Operations, and Medical Affairs. Lead feasibility/site selection, manage site contracts and performance, oversee CRO/vendor KPIs, control budgets and accruals, and maintain trial master file inspection readiness while ensuring compliant ICH-GCP execution.

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FursaFursa
Natera
Natera
1 day ago

Clinical Program Operations Manager, Therapeutics & Innovation

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Last checked: 33 minutes agoStatus: Live

Job Summary

Own end-to-end operational delivery for oncology clinical trials, from startup through database lock. Build and maintain integrated timelines, dashboards, and risk logs; drive enrollment forecasts and cross-functional execution across Regulatory, Quality, Data Management, Biostatistics, Laboratory Operations, and Medical Affairs. Lead feasibility/site selection, manage site contracts and performance, oversee CRO/vendor KPIs, control budgets and accruals, and maintain trial master file inspection readiness while ensuring compliant ICH-GCP execution.
Location: United States
Workplace: Remote
Employment Type: Full time
Job Function: Business Operations

Key Responsibilities

  • •Develop and maintain integrated study timelines/critical path from startup through database lock; hold internal functions and vendors accountable to committed dates.
  • •Lead feasibility and site selection through activation planning; manage site contracts, budgets, essential documents, IRB/EC submissions, and green-light criteria.
  • •Monitor site performance vs operational metrics (enrollment, screen failure rates, protocol deviations, query aging, site payments) and drive corrective actions.
  • •Manage CRO and vendor selection, scopes of work, change orders, invoicing/accruals, and governance against KPIs/SLAs.
  • •Maintain trial master file completeness and inspection readiness; coordinate compliance with ICH-GCP/FDA/internal SOPs and operational safety reporting elements.
Travel: Medium travel

Pay and Benefits

Salary: USD 116,200 - 145,200 annually
Perks:MedicalDentalVisionLife InsuranceDisability401kCommuter Benefits

Key Requirements

  • •Bachelor’s degree in a life science or related field (MS, PharmD, or PhD preferred).
  • •Minimum 5 years of clinical research experience, including at least 3 years managing oncology trials in a program or project management capacity.
  • •Working knowledge of ICH-GCP, applicable FDA regulations, IRB/EC processes, and trial master file/inspection readiness requirements.
  • •Proficiency with CTMS, eTMF, EDC, and IRT systems, plus project management tools such as Smartsheet or MS Project.
  • •Experience managing CRO and site contracts, budgets, and change orders (PMP or equivalent preferred).
Experience:Clinical researchOncologyBiotechnology
Education:Bachelor's
Skills:Independent ownershipProactive problem-solvingCross-functional alignmentData-driven decision-makingClear communication
Certifications:PMP
Tech Stack:CTMSETMFEDCIRTSmartsheetMS ProjectMicrosoft OfficeGantt chart

Company Brief

Natera
Develops and commercializes genetic testing and diagnostics focused on reproductive health, oncology, and organ transplant to inform clinical decision-making and improve patient outcomes.
Industry: Diagnostics
Company Size: Enterprise (1,001+ employees)
Revenue: USD 500M to 1B
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: San Carlos, United States
Founded: 2004
WebsiteLinkedIn