Clinical Program Operations Manager, Therapeutics & Innovation

8 hours, 48 minutes ago
Full-time
Senior
Project and Program Management
Natera

Natera

Natera specializes in cell-free DNA testing, providing advanced genetic testing services for oncology, women's health, and organ health to help families diagnose and manage genetic diseases.

Pharmaceuticals
1K-5K
Founded 2004

Description

  • Develop and maintain integrated study timelines, critical paths, dashboards, milestone reports, and risk logs.
  • Lead feasibility, site selection, activation planning, contracts, budgets, essential documents, and IRB/EC submissions.
  • Monitor site performance, enrollment, screen failures, protocol deviations, query aging, and payments; implement corrective actions.
  • Manage CRO and vendor selection, scopes of work, contracts, change orders, invoices, accruals, KPIs, and service agreements.
  • Coordinate central laboratory, IRT, EDC, eCOA, imaging, clinical supply, and logistics vendors.
  • Manage study budgets, resource plans, forecasts, actual spend, accruals, and cost-schedule trade-offs.
  • Maintain trial master file completeness and inspection readiness while partnering on deviations, CAPAs, audits, and inspections.
  • Lead operational planning for investigator meetings, site visits, monitoring visits, steering committees, and data reviews.
  • Manage data cleaning, query resolution, and database lock readiness.
  • Translate protocols and clinical objectives into operational plans, monitoring strategies, and resourcing models; travel up to approximately 25%.

Requirements

  • Bachelor’s degree in life science or a related field required; MS, PharmD, or PhD preferred.
  • At least 5 years of clinical research experience, including 3+ years managing oncology trials in a program or project management capacity.
  • Experience managing an oncology study from startup through database lock preferred.
  • Working knowledge of ICH-GCP, FDA regulations, IRB/EC processes, TMF, and inspection readiness requirements.
  • Proficiency with CTMS, eTMF, EDC, IRT, Smartsheet or MS Project, and Microsoft Office.
  • Experience managing CRO and site contracts, budgets, and change orders.
  • Experience in a small- to mid-sized biotechnology company preferred.
  • PMP or equivalent certification preferred.
  • Ability to work independently, manage competing priorities, use operational data to identify delays, and guide cross-functional initiatives.
  • Clear communication, vendor accountability, relationship-building, PHI handling, and completion of HIPAA/privacy training within 30 days of hire.

Benefits

  • Remote USA position.
  • Salary range of $116,200–$145,200 USD.
  • Medical, dental, vision, life, and disability coverage for eligible employees and dependents.
  • Free testing for employees and immediate family, plus fertility care benefits.
  • Pregnancy and baby bonding leave.
  • 401(k) and commuter benefits.
  • Employee referral program.

Interested in this position?

Apply directly on the company website

Apply Now

Similar Roles

Public Policy Research Manager

K.L. Scott & Associates 11-50 Professional Services

KLSA is seeking a Public Policy Research Manager to lead its research function, directing policy studies and evaluations that assess community impacts and produce actionable recommendations for policymakers and government leaders.

Agile Power BI Python R Tableau
8 hours, 18 minutes ago

Grants Manager

K.L. Scott & Associates 11-50 Professional Services

K.L. Scott & Associates is seeking a Grants Manager to oversee competitive grant and formal merit-review processes from planning through closeout, ensuring impartial, consistent, compliant, and well-documented application evaluations.

Salesforce
8 hours, 18 minutes ago

Design Program Manager, Context Platform

Figma 1K-5K Internet Software & Services

Figma is seeking a senior Design Program Manager to build and lead program operations for its new Context Platform pillar, coordinating interconnected design, engineering, and cross-functional teams shaping how organizational design context supports product development.

Design Systems
8 hours, 33 minutes ago

Senior Manager - Technical Implementation & Value Realization

PackageX 11-50 Professional Services

PackageX is seeking a Senior Manager, Technical Implementation & Value Realization to lead enterprise customer implementations, adoption, and measurable business outcomes for its physical logistics execution platform.

Computer Vision ERP NetSuite Oracle SAP
8 hours, 48 minutes ago

You're on a roll! Sign up now to keep applying.

Sign Up

Already have an account? Log in

Used by 14,729+ remote workers