Senior Clinical Data Associate

Natera; San Carlos (CA); Remote; USD 92,000 - 116,000; Full time

Job summary

Join a pioneering firm in the field of genetic testing as a Senior Clinical Data Associate. This role offers the chance to contribute to clinical studies that drive the development of innovative molecular diagnostic tests. You will play a vital role in managing clinical data, ensuring compliance with FDA regulations, and collaborating with cross-functional teams to meet project timelines. Natera is committed to fostering a diverse and inclusive workplace, where your contributions will help shape the future of healthcare. If you are passionate about data management and want to make a meaningful impact, this opportunity is perfect for you.

Benefits

Comprehensive medical, dental, and vision plans

Free testing for employees and families

Fertility care benefits

Pregnancy and baby bonding leave

401k benefits

Commuter benefits

Generous employee referral program

Qualifications

• 5+ years managing EDC for medical device trials required.
• Bachelor's degree in data science or equivalent is mandatory.

Responsibilities

• Support clinical data management activities across studies.
• Ensure accurate development of data integrations between databases.

Skills

Clinical Data Management

EDC Management

FDA Regulations

Interpersonal Skills

Communication Skills

Leadership Skills

Organization Skills

Education

Bachelor’s degree in data science or relevant discipline

Advanced degree

Certificate in clinical data management

Tools

Microsoft Office

Google Suite

Job description

Position Summary

The Senior Clinical Data Associate is responsible for providing clinical data management support for clinical studies that support the development, validation, and commercialization of non-invasive molecular diagnostic tests.

Primary Responsibilities

• Supports clinical data management activities across clinical studies managed by the Clinical Operations department.
• Supports development and maintenance of all CDM related SOPs, Work Instructions.
• Supports strategic initiatives for the clinical data management function.
• Maintain standardized processes for data management activities.
• Represent clinical data management in cross-functional meetings.
• Reviews trial protocols and assists in the planning and implementation of the Clinical Data Management process.
• Participate in study document reviews (e.g., clinical study protocols, statistical analysis plans).
• Work cross-functionally with other functions to meet project deliverables and timelines for clinical data acquisition, quality checking, and reporting.
• Responsible for oversight of data transfers for assigned studies.
• Participate as needed in the preparation and presentation of data.
• Ensure accurate development and execution of data integrations between databases such as EDC, LIMS, and other internal and external data sources.
• Ensure data system compliance by following the established guidelines (e.g., FDA).
• Performs other duties as assigned.
• 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.
• Contribute to the end-to-end data workflow and database integration logistics.
• Work cross-functionally with engineering and IT departments to develop study specific reports, dashboards, and database requirements.
• Responsible for ensuring complete and accurate CDM documentation such as eCRF specifications, eCRF completion guidelines, annotated CRFs, data validation specifications, data transfer agreements, and data management plans.
• Ensure completeness, accuracy, and consistency of clinical data and data structure.
• Responsible for CRO oversight of data management activities.
• Contribute to CRF Design and data management strategy.
• Serve as the primary liaison between internal stakeholders and the CRO with respect to study data requirements.

Qualifications

• Bachelor’s degree in data science, other relevant discipline, or equivalent required. Advanced degree preferred.
• Minimum of 5 years of experience in managing EDC for medical device, in-vitro diagnostic device trials, and/or laboratory data management.
• Certificate in clinical data management preferred but not required.
• Employee must provide records of current training or complete training relating to HIPAA/PHI privacy, human subjects protection, and GCP.

Knowledge, Skills, And Abilities

• Familiar with the FDA regulations relevant to clinical trials and EDC.
• Proficiency in Microsoft Office and Google Suite platforms.
• 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.
• Ability to collaborate with the study team, cross-functional team members, and external collaborators.

The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications, and specific office location. This may differ in other locations due to cost of labor considerations.

Remote USA

$92,200—$115,300 USD

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.