Manager, Clinical Trials

2 hours, 36 minutes ago
Full-time
Lead
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

  • Manage the execution and conduct of complex clinical studies from start-up through close-out.
  • Select and manage vendors and CROs to ensure deliverables are completed within budget, timeline, and protocol requirements.
  • Manage study contracting, budgeting, forecasting, accruals, and payment processes for clinical trial vendors and investigative sites.
  • Lead protocol, informed consent, investigator selection, training materials, monitoring plans, CRF development, TMF maintenance, and clinical report preparation.
  • Collaborate with Clinical Data Management to ensure accurate CRF content, completion guidelines, data listings, and study reports.
  • Train CROs, vendors, investigators, and study coordinators on study protocol implementation.
  • Hire, train, manage, and oversee clinical trial staff.
  • Monitor study progress and provide status updates to stakeholders.
  • Support sample management and 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 clinical trial leadership role.
  • 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-GCP.
  • Proficiency in MS Word, Excel, and PowerPoint.
  • Strong analytical, organizational, planning, communication, and interpersonal skills.
  • Ability to collaborate effectively with cross-functional teams and external collaborators.
  • Ability to prioritize and manage multiple tasks in a fast-paced environment.
  • Must complete or provide current training in HIPAA/PHI privacy, Human Subjects Protection, GCP, and Natera compliance/security training.
  • Must pass a post-offer criminal background check.

Benefits

  • Remote USA position.
  • Salary range of $115,800 to $144,700 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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