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Clinical Trial Manager

1 hour, 53 minutes ago
United States
Full-time
Senior
Project Manager
Project and Program Management
GCP HIPAA
Apply Now
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
View All Jobs 82

Description

  • Manage the execution and conduct of complex clinical studies from start-up through close-out.
  • Select and manage vendors and CROs to ensure deliverables, budget, timeline, and protocol compliance.
  • Oversee study contracting, budgeting, forecasting, accruals, and vendor payment processes.
  • Lead study activities including protocol and informed consent preparation, investigator selection, monitoring plan development, CRF design, TMF maintenance, and clinical report preparation.
  • Partner with Clinical Data Management to ensure correct CRF content, completion guidelines, data listings, and study reports.
  • Train CROs, vendors, investigators, and study coordinators on study protocol implementation.
  • Hire, train, oversee, and mentor clinical trial staff and support junior clinical operations staff.
  • Monitor study progress and provide status updates to stakeholders.
  • Support prospective sample testing for studies where Natera serves as a central testing facility.
  • Develop Clinical Department SOPs and participate in audits as needed.

Requirements

  • Bachelor’s degree in life sciences or another relevant discipline required; advanced degree preferred.
  • 8 years of clinical research experience, including at least 4 years in a leading role managing clinical trials.
  • 4-7 years of experience supporting clinical trials in a regulated environment.
  • Experience managing CROs preferred.
  • Knowledge of clinical trial SOPs, FDA regulations, and ICH-GCPs.
  • Demonstrated analytical skills with the ability to identify problems and solutions independently.
  • Strong collaboration skills with study teams, cross-functional partners, and external collaborators.
  • Proficiency in MS Word, Excel, and PowerPoint.
  • Strong organization, planning, communication, and interpersonal skills.
  • Ability to prioritize and handle multiple tasks in a fast-paced, dynamic environment.
  • Current or completed training in HIPAA/PHI privacy, Human Subjects Protection, and GCP is required.
  • Must maintain current Natera training requirements, including General Policies and Procedure Compliance and security training.

Benefits

  • Remote USA role with a pay range of $138,600 to $173,300 USD.
  • Comprehensive medical, dental, vision, life, and disability coverage for eligible employees and dependents.
  • Free testing for employees and their immediate families.
  • Fertility care benefits.
  • Pregnancy and baby bonding leave.
  • 401(k) benefits.
  • Commuter benefits.
  • Generous employee referral program.

Interested in this position?

Apply directly on the company website

Apply Now

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