Laboratory Data - Clinical Data Manager

The Clinical Data Manager role in Natera’s Clinical Trials Services Operations group is responsible for providing clinical data management support for the clinical trials of our pharma sponsor customers and consortia using Signatera, our first-in-class assay interrogating circulating tumor DNA (ctDNA) for the non-invasive detection and diagnosis of various cancers. As a budding leader in this team, you will be expected to provide ownership and a customer- focused, project-based, clinical data management service to one or more of our customer’s studies, emphasizing the end-to-end support of the complex clinical data generated by our Signatera tests. The essential skills are deep knowledge of the clinical data lifecycle for biomarker-driven studies; knowledge of clinical data standards, such as the CDISC; great attention to detail, a proactive mindset, and follow-through on problems as they surface. The ability to manipulate data through scripting (python, R) and or BI tools (PowerBI) is highly desired but not required.

 

PRIMARY RESPONSIBILITIES

• Lead clinical data management delivery on one or more studies or special projects with minimal supervision.
• Use your excellent communication and collaboration skills to act as the point of contact for Data Management on your studies for an internal and external audience of various management levels.
• Apply a data-driven approach to your work by utilizing our standard reports to track study progress and ensure timeliness and quality expectations are met.
• Take a proactive approach to prevent problems, but apply thoughtful and collaborative problem solving skills, using good judgment to determine when to escalate and ask for help.
• Take ownership of the quality and integrity of the data from your studies, by ensuring completeness, accuracy and consistency of the clinical data and data reports and structure.
• Tasks could range from in scope the development and implementation of new processes internally and with external vendors, to routine tasks yet to be automated, including data entry, data quality checking, data transfers and report compilation.
• Display an innovative mindset with a bias towards continuous improvement and automation of manual routine tasks to help us scale our processes to meet increasing demand.
• Apply your significant clinical data management experience to thoroughly understand the data management needs of the protocol of your studies, including fluency working with LIMS and lab data.
• Apply knowledge of CDISC terminology and standards and experience working with SDTM/SDTMv as appropriate for the requirements of your study.
• This role works with PHI on a regular basis both in paper and electronic form and has 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 or other relevant discipline, or equivalent domain experience required.
• Minimum of 3 years of experience in a Clinical Data Management role for medical device or in-vitro diagnostic device trials. Experience at a CRO or interventional biotech companies is highly desired.

KNOWLEDGE, SKILLS, AND ABILITIES

• Familiar with the FDA regulations relevant to clinical trials.
• Proficiency Google Workspace apps - the ability to manipulate and analyze data sets with gSheets and/or Excel is required.
• 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$113,900—$142,400 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