Manger, Clinical Trials jobs in United States
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Natera · 15 hours ago

Manger, Clinical Trials

Natera is a global leader in cell-free DNA testing, dedicated to oncology, women’s health, and organ health. The Clinical Trial Manager will manage all aspects of clinical trials from start-up through close-out, ensuring compliance with study protocols and regulatory requirements while leading a team and collaborating with vendors and stakeholders.

BiotechnologyGeneticsHealth DiagnosticsMedicalWomen's
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H1B Sponsor Likelynote

Responsibilities

Manage the execution and conduct of all aspects of very complex clinical studies to ensure that timelines, cost, and quality metrics are met
Responsible for selection of vendors/CROs and provide effective ongoing management to vendors/CROs working on the project to ensure compliance and execution of project deliverables within the approved budget, study timeline, and study protocol. Works closely with investigative site personnel, CROs, and other study vendors
Manage study contracting, budget, forecasting, accruals and payment process for all clinical trial vendors including investigational sites
Lead study-related activities such as protocol and informed consent preparation, investigator selection, study training material development and delivery, monitoring plans development and execution, CRFs, design and completion, TMF maintenance, protocol amendment and clinical report preparation, as required
Collaborate with Clinical Data Management group to ensure correct CRFs content is collected, prepare comprehensive completion guidelines, and design effective data listings and study reports
Train CROs, vendors, investigators and study coordinators on implementation of study protocol
Hire, train and oversee Clinical trial staff, and serve as a resource for others within the company for clinical trials management expertise
Monitor and track clinical trial progress and provide status update to stakeholders
Support prospective sample testing for studies where Natera functions as a central testing facility
Partner with other research and development groups to create a culture of mutual respect and focus on delivery of high-quality project results
Hire, train and oversee Clinical trial staff, and mentor junior clinical operations staff
Develop Clinical Department SOPs and participate in audits as needed

Qualification

Clinical Trial ManagementCRO ManagementRegulatory ComplianceAnalytical SkillsMS Office ProficiencyInterpersonal SkillsLeadership SkillsOrganizational SkillsTime Management

Required

Bachelor's degree in life sciences, or other relevant discipline required
8 years of clinical research experience, including at least 4 years of experience in managing clinical trials as a leading role
4-7 years of experience in supporting clinical trials in a regulated environment
Knowledge and understanding of Clinical Trial SOPs, FDA Regulations, and ICH-GCPs governing the conduct of clinical trials
Demonstrated analytical skills and ability to identify problems and solutions independently
Ability to collaborate with the study team, cross functional team members and external collaborators
Proficiency in MS Word, Excel and PowerPoint
Good organization and planning skills
Strong interpersonal skills and communication skills (both written and oral)
Strong leadership skills, self-motivated, adaptable to a dynamic and fast paced environment
Must have excellent organizational and time management skills
Ability to prioritize and handle multiple tasks and projects in a fast-paced environment
Employee must provide records of current training or complete training relating to HIPAA/PHI privacy, Human Subjects Protection, and GCP training
Must maintain a current status on Natera training requirements including General Policies and Procedure Compliance and security training
Employee must pass post offer criminal background check

Preferred

Advanced degree preferred
Experience in managing CROs is preferred

Benefits

Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents
Free testing in addition to fertility care benefits
Pregnancy and baby bonding leave
401k benefits
Commuter benefits
Generous employee referral program

Company

Natera specializes in cell-free DNA testing to provide a more targeted interventions to oncology, women's health, and organ health.

H1B Sponsorship

Natera has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (90)
2024 (72)
2023 (37)
2022 (71)
2021 (64)
2020 (40)

Funding

Current Stage
Public Company
Total Funding
$1.16B
Key Investors
Matthew Rabinowitz,Roelof BothaSofinnova InvestmentsHarmony Partners,OrbiMed
2023-09-07Post Ipo Equity· $250M
2022-11-15Post Ipo Equity· $400.05M
2022-03-16Post Ipo Equity· $5M

Leadership Team

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Steve Chapman
CEO
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Jonathan Sheena
Co-Founder, Board Member
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Company data provided by crunchbase