POSITION SUMMARY:
This Senior Manager, Clinical Trial is responsible for managing all aspects of clinical trials to support the development, validation, and commercialization non-invasive molecular diagnostic tests. This role manages clinical operations staff and all aspects of the trials independently, including study design, protocol implementation, site monitoring, and recruitment site management.
PRIMARY RESPONSIBILITIES:
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Responsible for the implementation of clinical trial activities per study protocol. Works closely with investigative site personnel, CROs, and other study vendors
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Manage and coach clinical research staff.
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Manage study contracting, budget and payment process for all clinical trial vendors including investigational sites.
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Partner with department head to develop department procedures and develop infrastructure.
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Design study related documents, including but not limited to study protocol, informed consent forms, CRFs, and regulatory binders.
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Train CROs, vendors, investigators and study coordinators on study protocol and relevant
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Monitor and track clinical trial progress and provide status update to stakeholders.
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Partner with other research and development groups to achieve deliverables.
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This role works with PHI on a regular basis both in paper and electronic form and have an access to various technologies to access PHI (paper and electronic) in order to perform the job
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Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.
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Must maintain a current status on Natera training requirements.
QUALIFICATIONS:
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Bachelor’s degree in life sciences, other relevant discipline, or equivalent required. Advanced degree preferred.
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5-10 years of clinical research experience, including at least 3-5 years of experience in managing clinical trials as a leading role.
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2+ years of experience of managing staff. Experience in managing CROs is preferred.
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Experience managing all aspects of the trials independently, including study design, protocol implementation, site monitoring, sample management, and recruitment site management.
KNOWLEDGE, SKILLS, AND ABILITIES:
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Familiar with the clinical research regulations.
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Ability to collaborate with the study team, cross functional team members and external
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Proficiency in MS Word, Excel and PowerPoint.
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Good organization and planning skills.
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Strong interpersonal skills and communication skills (both written and oral).
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Strong leadership skills, self-motivated, adaptable to a dynamic and fast paced environment.
OUR OPPORTUNITY
Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.
The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.
WHAT WE OFFER
Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!
For more information, visit www.natera.com.
Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.
All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.
If you are based in California, we encourage you to read this important information for California residents.
Link: https://www.natera.com/notice-of-data-collection-california-residents/
Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.
For more information:
- BBB announcement on job scams
- FBI Cyber Crime resource page