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. Central Lab Data Support prospective sample data management for studies where Natera functions as a central testing facility

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 Data Management Responsibilities for In-House Studies EDC development and maintenance, including database programming

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.

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