Senior Manager, Clinical Trials (Organ Health) Details

Senior Manager, Clinical Trials (Organ Health)

Natera - San Carlos, CA

Employment Type : Full-Time

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:

• Responsible for the implementation of clinical trial activities per study protocol. Works closely with investigative site personnel, CROs, and other study vendors
• Manage and coach junior clinical research staff (e.g. CRA, CTA)
• Manage study contracting, budget and payment process for all clinical trial vendors including investigational sites.
• Partner with department head to develop department procedures and develop infrastructure.
• Design study related documents, including but not limited to study protocol, informed consent forms, CRFs, and regulatory binders.
• Train CROs, vendors, investigators and study coordinators on study protocol and relevant requirement.
• Monitor and track clinical trial progress and provide status update to stakeholders.
• Partner with other research and development groups to achieve deliverables.
• 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
• 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.
• Must maintain a current status on Natera training requirements.
• Employee must pass post offer criminal background check.

QUALIFICATIONS:

• 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.
• 1-2 years of experience of managing staff. Experience in managing CROs is preferred.
• Experience managing all aspects of the trials independently, including study design, protocol implementation, site monitoring, and recruitment site management.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Familiar with the clinical research regulations.
• 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.

PHYSICAL DEMANDS & WORK ENVIRONMENT:

• This position requires the ability to use a computer keyboard, communicate over the telephone and read printed material.
• Duties may require working outside normal working hours (evenings and weekends) at times.
• Travel is required (up to 15%)

OUR OPPORTUNITY
Driven by the passion for elevating the science and utility of genetic testing, Natera is committed to helping families identify and manage genetic diseases. Natera is a rapidly-growing diagnostics company with proprietary bioinformatics and molecular technology for analyzing DNA. Our complex technology has been proven clinically and commercially in the prenatal testing space and we are actively researching its applications in the liquid biopsy space for developing products with oncology applications.
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. Healthy catered lunches, Premium snacks and beverages, Onsite gym with cardio and weight-training equipment, Game room with satellite TV, Onsite dry cleaning and alteration service with pick-up and delivery, Employee-organized sport leagues, Happy hours and BBQs, 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.