Manager, Clinical Trials

🕒 July 9

🇺🇸 United States – Remote

💵 $115.8k - $144.7k / year

⏰ Full Time

🟠 Senior

🔴 Lead

👔 Manager

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Natera

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2004

🏥 Healthcare

🧬 Biotechnology

⚕️ Healthcare Insurance

Healthcare • Biotechnology • Healthcare Insurance

Natera is a global leader in cell-free DNA testing technology, specializing in non-invasive genetic testing and diagnostics. The company's innovative solutions focus on areas such as prenatal screening, cancer detection, and organ transplant monitoring. By using advanced bioinformatics and DNA analysis, Natera provides healthcare professionals and patients with critical information to make more informed medical decisions.

📋 Description

• Manage execution and conduct of complex clinical studies to meet timeline, cost, and quality metrics • Select and manage vendors and CROs, ensuring compliant delivery within budget, timeline, and protocol requirements • Manage study contracting, budgets, forecasting, accruals, and vendor and investigational-site payments • Lead protocol and informed-consent preparation, investigator selection, training-material development, monitoring plans, CRF design and completion, TMF maintenance, protocol amendments, and clinical reports • Collaborate with Clinical Data Management on 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 • Provide clinical-trials management expertise and serve as a resource within the company • Monitor and track trial progress and provide stakeholder status updates • Support sample management and prospective sample testing when Natera serves as the central testing facility • Partner with research and development groups to deliver high-quality project results • Develop Clinical Department SOPs and participate in audits as needed • Handle protected health information (PHI) in paper and electronic form • Maintain required HIPAA/PHI privacy, Human Subjects Protection, GCP, compliance, and security training • Pass a post-offer criminal background check

🎯 Requirements

• Bachelor’s degree in life sciences or another relevant discipline required • 8 years of clinical research experience, including at least 4 years managing clinical trials in a leading role • 4–7 years supporting clinical trials in a regulated environment • Knowledge of Clinical Trial SOPs, FDA Regulations, and ICH-GCPs • Analytical skills and ability to independently identify problems and solutions • Proficiency in MS Word, Excel, and PowerPoint • Organization, planning, and time-management skills • Strong written and oral interpersonal and communication skills • Leadership skills and ability to work in a dynamic, fast-paced environment • Ability to prioritize and handle multiple tasks and projects • Experience managing CROs preferred • Advanced degree preferred • Current or completed HIPAA/PHI privacy, Human Subjects Protection, GCP, compliance, and security training • Ability to pass a post-offer criminal background check

🏖️ Benefits

• Comprehensive medical, dental, vision, life and disability plans for eligible employees and dependents • Free testing for Natera employees and their immediate families • Fertility care benefits • Pregnancy and baby bonding leave • 401k benefits • Commuter benefits • Employee referral program