Senior Manager, Clinical Trials

About the role

This Senior Manager, Clinical Trials is responsible for managing all aspects of clinical trials to support the development, validation, and commercialization of non-invasive molecular diagnostic tests. The role owns the end-to-end execution of clinical trial programs, managing clinical operations staff and all trial activities independently. The hire will oversee study design, protocol implementation, site monitoring, and recruitment site management while ensuring strict adherence to protocols and regulations. They will act as the central operational lead interfacing with investigative sites, CROs, and internal stakeholders to drive timely and high-quality data generation. This position requires ownership of complex trial logistics and vendor relationships to de-risk study execution and accelerate timelines. The role directly supports Natera's mission by ensuring robust and compliant clinical data that informs product development and commercialization decisions.

Key facts

What you'll do

Design and implement comprehensive clinical trial strategies in alignment with study objectives and regulatory requirements.

Lead the development and refinement of study protocols, informed consent forms, case report forms, and regulatory documentation to ensure clarity and compliance.

Manage and coach clinical research staff, including study coordinators and site personnel, to build capacity and ensure standard execution.

Oversee study contracting, budgeting, and payment processes for all clinical trial vendors, including investigational sites and CROs.

Partner with department leadership to develop department procedures, infrastructure, and operational frameworks that scale.

Monitor and track clinical trial progress across multiple studies, providing regular status updates to internal and external stakeholders.

Coordinate closely with CROs, vendors, investigators, and study coordinators to resolve issues and maintain study integrity.

Collaborate with cross-functional research and development teams to align trial milestones and deliverables with product timelines.

Handle all interactions involving protected health information in both paper and electronic formats, utilizing secure technologies to perform job responsibilities.

Ensure completion of HIPAA and PHI privacy training, General Policies and Procedure Compliance training, and security training within the first 30 days of hire.

Maintain current status on all Natera training requirements and compliance certifications throughout employment.

Uphold Natera's quality standards by applying clinical research regulations and best practices to every phase of trial management.

Serve as the primary operational partner for study sites to proactively address barriers and keep recruitment and data collection on schedule.

Drive continuous improvement by analyzing trial performance metrics and implementing actionable improvements to processes and documentation.

Requirements

Bachelor's degree in life sciences, other relevant discipline, or equivalent required. Advanced degree preferred.

5-10 years of clinical research experience, including at least 3-5 years of experience in managing clinical trials as a leading role.

2+ years of experience managing staff, with preferred experience in managing CROs.

Demonstrated ability to manage all aspects of trials independently, including study design, protocol implementation, site monitoring, sample management, and recruitment site management.

Familiarity with clinical research regulations and compliance standards governing human subject research and protected health information.

Strong written and oral communication skills to effectively interact with study teams, cross-functional partners, and external vendors.

Proficiency in Microsoft Word, Excel, and PowerPoint for document creation, data analysis, and presentation development.

Excellent organizational and planning skills to manage multiple timelines, deliverables, and stakeholder expectations in a fast-paced environment.

Strong leadership skills, self-motivation, and adaptability to thrive in a dynamic, high-growth environment.

Ability to work with both paper and electronic PHI using various technologies while maintaining strict confidentiality and data security.

Commitment to completing required training within specified timeframes and maintaining up-to-date certifications.

Nice to have

Experience with oncology, women's health, or non-invasive diagnostic testing clinical trials.

Familiarity with cfDNA or molecular diagnostic development programs.

Experience implementing decentralized or hybrid clinical trial models.

Knowledge of electronic data capture tools and clinical trial management systems.

Practical notes

This is a full-time position based in the United States with remote work eligibility.

Candidates must be authorized to work in the United States without sponsorship for this role.

No specific travel requirements are outlined in the current posting.

Employment is contingent upon successful completion of background checks and required compliance training.

The compensation range is provided as a guideline and may vary based on candidate qualifications, experience, location, and other factors as described in the pay transparency notice.