[Remote] Clinical Data Mgr at Natera

United States

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Not SpecifiedCompensation

N/AExperience Level

N/AJob Type

Not SpecifiedVisa

N/AIndustries

Requirements

Bachelor’s degree in life sciences or other relevant discipline, or equivalent domain experience
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 of the FDA regulations relevant to clinical trials
Proficiency in Google Workspace apps (gSheets and/or Excel)
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 manipulate and analyze data sets with gSheets and/or Excel
Familiarity with the CDISC terminology and standards (SDTM/SDTMv)

Responsibilities

Lead clinical data management delivery on one or more studies or special projects with minimal supervision
Use excellent communication and collaboration skills to act as the point of contact for Data Management on studies for various management levels
Apply a data-driven approach to work by utilizing 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 studies, ensuring completeness, accuracy, and consistency of the clinical data and data reports
Develop and implement new processes internally and with external vendors
Automate routine tasks, 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
Apply knowledge of CDISC terminology and standards and experience working with SDTM/SDTMv as appropriate
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
Maintain a current status on Natera training requirements
Pass post-offer criminal background check

Skills

Natera

Genetic testing and diagnostics solutions provider

About Natera

Natera focuses on genetic testing and diagnostics, providing advanced solutions for cancer patients, transplant patients, and individuals assessing hereditary health risks. Their main technology is cell-free DNA (cfDNA) testing, which analyzes DNA fragments in the blood to detect minimal traces of cancer and assess organ health. Natera stands out by offering specialized tests like the Signatera ctDNA test and Panorama NIPT, along with genetic counseling services. The company's goal is to improve patient care and health outcomes through accurate genetic testing.

Austin, TexasHeadquarters

2004Year Founded

$149.9MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

1,001-5,000Employees

Benefits

Flexible medical plans

Investment options

Time off

Workplace perks

Risks

Hindenburg report accuses Natera of deceptive sales practices, risking legal challenges.

New Prospera Heart features may face slow adoption by healthcare providers.

Fetal RhD NIPT demand may drop post-RhIg shortage, affecting future sales.

Differentiation

Natera's Signatera test offers personalized ctDNA analysis for cancer patients.

Prospera Heart test uses unique Donor Quantity Score for transplant rejection detection.

Panorama NIPT test is a leader in non-invasive prenatal testing with 2 million tests.

Upsides

Increased adoption of liquid biopsy techniques boosts demand for Natera's cfDNA tests.

AI integration enhances accuracy and speed of Natera's cfDNA analysis.

Growing personalized medicine trend aligns with Natera's customized genetic tests.

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