Clinical Data Mgr

POSITION SUMMARY:

The Senior 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 3required.

• 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/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.

 

 

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$119,200—$148,950 USD

OUR OPPORTUNITY

Natera™ is a