Clinical Data Manager

Summary

Join Natera's Clinical Trials Services Operations group as a Clinical Data Manager and provide clinical data management support for clinical trials using Signatera, a first-in-class assay. You will be a key point of contact for data management, ensuring data quality and integrity. Responsibilities include leading data management delivery, collaborating with internal and external teams, and proactively addressing challenges. This role requires a Bachelor's degree, 3+ years of experience in clinical data management, and proficiency in Google Workspace apps. Experience with CDISC standards and scripting is highly desired. Natera offers competitive benefits, including comprehensive medical, dental, vision, life, and disability plans, as well as free testing for employees and their families.

Requirements

• 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
• Familiar with the FDA regulations relevant to clinical trials
• Proficiency Google Workspace apps - the ability to manipulate and analyze data sets with gSheets and/orExcel 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

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
• 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

Preferred Qualifications

• Experience at a CRO or interventional biotech companies is highly desired
• The ability to manipulate data through scripting (python, R) and or BI tools (PowerBI) is highly desired but not required

Benefits

• Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents
• 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!