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Associate Clinical Data Manager - (Remote) (344989BR)

Management

Manager

Yearly

No

Carlsbad, California, United States

1 in 5 men and 1 in 6 women worldwide develop cancer during their lifetime, and far too many will lose their battle every year. At Navigate we envision a disease free world – our talented and passionate team is at the forefront of enabling drug development by using transformative science to deliver high quality, world class clinical biomarker solutions so we can one day realize that vision. <br><br>Join us on our journey to turning innovative treatment ideas into reality to improve and extend patient lives across the globe. Navigate Biopharma, a fully owned subsidiary of Novartis, provides assay development, clinical trial testing, and companion diagnostics services to companies in the precision medicine field. At present, Navigate supports 100+ clinical trials from 30+ pharma, biotech, and diagnostic companies, including 8 of the top 15 oncology companies globally. <br><br>Local candidates preferred.<br><br>This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. <br><br>RESPONSIBILITIES:<br>- Work in a GMP/GCP/GLP/CLIA regulated environment and follow all applicable regulations<br><br>- Perform end-to-end delivery of data management services for multiple clinical trial projects with some guidance, ensuring quality deliverables on time<br><br>- Perform routine quality control of data for multiple complex clinical trial projects at various stages of data handling to ensure that all data are reliable and have been processed accurately (e.g., quality check of source data, databases and reports as required).<br><br>- Establish strong communication with GxP team, test method leads, project managers and all other collaborators<br><br>- Connect with Project Managers, GxP team and technical leads on a regular basis to meet data management deliverables for multiple projects and ensure achievements meet timelines and quality deliverables<br><br>- With minimal guidance, support Clinical Data Management (CDM) team with comprehensive CDM process and technical expertise in carrying out data projects<br><br>- Perform data remediation and other efforts related to researching and updating incomplete or missing information<br><br>- Perform extraction of data and generate required reports as requested<br><br>- Work with project team to identify and resolve data issues<br><br>- May perform data entry of a significant amount of information from electronic or hardcopy source materials such as patient demographics, clinical raw data and testing results into electronic databases and spreadsheets in accordance with project requirements as necessary<br><br>- Reviews and verifies source materials to determine accuracy and completeness of information; follows up to correct or complete data<br><br>- Assist with identification and correction of data errors in accordance with quality assurance procedures<br><br>- Assist with study close-out activities to verify data integrity and data completeness<br><br>- With guidance, prepares data validation documents and conducts data validation testing<br><br>- Provide status updates related to project tasks to management as necessary<br><br>- Assist with preparing or reviewing work instructions.<br><br>- Assist with preparing requirement/qualification documents and qualification testing for MIRTH channels.<br><br>- Ensuring that Quality Events such as incidents and deviations are accurately detailed, and for supporting/owning the immediate remediation and preventative actions<br><br>- Ensuring change requests are accurately initiated, completed, and approved prior to the use of the assay, system, instrument, software, etc. being changed<br><br>- Maintaining up-to-date training records and ensuring training is complete prior to performing specific job functions<br><br>- Following approved and effective procedures to perform specific job functions, and ensuring procedures accurately reflect activities being performed<br><br>[#video#https://www.youtube.com/watch?v=Mo1vwtVPVA0{#400,300#}#/video#]