- Experience
- 8+ yrs
- Salary
- USD 138,600 – USD 173,300 / year
- Openings
- 1
- Posted
- 5 hours ago
- Work mode
- Work from home
- Education
- Bachelor’s degree
- Eligibility
- Candidates with a bachelor’s degree in life sciences or a related discipline, substantial clinical research experience, and a background in leading clinical trials are suitable. Applicants must be able to work with protected health information, complete required privacy and compliance training, and…
- Resume
- Required to apply
Job description
Position Summary
The Clinical Trial Manager will oversee clinical studies from initial setup through final close-out. This role calls for someone who can independently run all phases of a trial and bring functional expertise to keep timelines, budgets, and quality standards on track while ensuring full alignment with the study protocol, internal procedures, and applicable regulatory rules.
Primary Responsibilities
- Direct the day-to-day execution of highly complex clinical studies so time, cost, and quality targets are achieved.
- Choose vendors and CROs, then manage them continuously to make sure deliverables are completed according to the approved budget, study schedule, and protocol. Work closely with site teams, CRO partners, and other vendors involved in the study.
- Handle study contracts, budgeting, forecasting, accruals, and payment workflows for all trial vendors, including investigative sites.
- Lead key study activities such as protocol and informed consent development, investigator selection, training material creation and delivery, monitoring plan development and implementation, CRF development and completion, TMF upkeep, protocol amendments, and clinical report preparation as needed.
- Work with Clinical Data Management to confirm the right CRF data is captured, create detailed completion instructions, and build effective data listings and study reports.
- Train CROs, vendors, investigators, and study coordinators on how to execute the study protocol.
- Recruit, coach, and supervise clinical trial staff, while also serving as an internal subject matter resource for trial management.
- Track study progress, monitor milestones, and share status updates with stakeholders.
- Support prospective sample testing for studies where Natera serves as the central testing lab.
- Collaborate with research and development teams to foster a respectful, cooperative environment focused on delivering strong project outcomes.
- Mentor junior clinical operations team members.
- Develop standard operating procedures for the Clinical Department and participate in audits when required.
- Handle protected health information regularly in both paper and electronic formats and use systems that provide access to PHI as part of the job.
- Provide proof of current HIPAA/PHI privacy, Human Subjects Protection, and GCP training, or complete this training as required.
- Maintain up-to-date compliance with Natera training requirements, including General Policies and Procedure Compliance and security training.
Qualifications
- A bachelor’s degree in life sciences or another relevant field is required; an advanced degree is preferred.
- At least 8 years of clinical research experience, including a minimum of 4 years in a lead role managing clinical trials.
- 4–7 years of experience supporting clinical trials in a regulated environment.
- Prior experience managing CROs is preferred.
Knowledge, Skills, and Abilities
- Solid understanding of clinical trial SOPs, FDA regulations, and ICH-GCP requirements.
- Strong analytical thinking with the ability to identify issues and resolve them independently.
- Ability to work effectively with study teams, cross-functional partners, and external collaborators.
- Comfort using MS Word, Excel, and PowerPoint.
- Well-developed planning and organizational abilities.
- Strong written and verbal communication skills.
- Confident leadership style with a self-driven approach and adaptability in a fast-moving environment.
- Excellent time management and organizational discipline.
- Ability to manage competing priorities and multiple projects in a high-pressure setting.
Compensation
The posted pay range for Remote USA is USD 138,600 to USD 173,300 annually. Final compensation may vary based on skills, depth of experience, certifications, and office location, and could differ in other locations due to labor market conditions.
About the Company
Natera is a global leader in cell-free DNA testing with a focus on oncology, women’s health, and organ health. The company works to make personalized genetic testing and diagnostics a standard part of care so that health issues can be identified earlier and treated more precisely, helping people live longer, healthier lives.
The team includes statisticians, geneticists, physicians, laboratory scientists, business professionals, software engineers, and other specialists from top institutions. The work environment is fast-paced, challenging, and designed for growth, with employees contributing to meaningful advances in genetic disease management.
Benefits
Eligible employees receive comprehensive medical, dental, vision, life, and disability coverage for themselves and dependents. Additional offerings include fertility care benefits, free testing for employees and their immediate families, pregnancy and baby bonding leave, 401(k) benefits, commuter benefits, and a generous employee referral program.
Equal Opportunity and Hiring Notice
The employer maintains an equal opportunity policy and supports a diverse, inclusive workplace. Applicants are considered without discrimination based on race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability, or other legally protected characteristics. Qualified candidates with criminal histories are also considered in line with applicable law.
Safety and Fraud Alert
Only emails sent from the company’s official domain should be treated as genuine. The company does not conduct interviews by text message and will not request personal information until after the candidate has engaged with the company, spoken with a recruiter, and met with the hiring team. Candidates are warned to be alert for fraudulent communications and cybercrime-related scams.
Additional Information
If you are located in California, you may need to review the notice for California residents regarding data collection. The company also references external resources related to job scams and cybercrime awareness.