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Job Details

Associate Patient Data Manager





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>Your Responsibilities include, but are not limited to: <br>• Perform a variety of tasks in the coordination and review of final project results. Collaborate with physicians, Project Managers and other departmental staff in the preparation of reporting for BioPharma sponsors.<br>• Work in a GMP/GCP/GLP/CLIA regulated environment and is responsible for following all applicable regulations<br>• Gather, compile and complete quality review and inspection (proofread) of test reports for format, text, and signatures; ensure consistency with and accuracy as it relates to established standards.<br>• Collaborate with Project Managers and internal laboratory staff to prioritize project deliverables, monitor and document progress, resolve issues and provide timely updates to team members.<br>• Assist in authoring SOPs, work instructions, internal control documents, and training aids.<br>• Assist in evaluating project performance and recommend process improvements.<br>• Provide input for the configuration and refinement of LIMS, design specifications for new report layouts and test methodology macros.<br>• Transcribe data from test reports into Sponsor eCRFs.<br>• Assist with interim and end of study data transfers.<br>• Compile bioanalytical and close out reports for BioPharma sponsors.<br>• Coordinate internal training of new members on study projects.<br>• Complete related administrative duties, such as identification and retrieval of completed clinical trial subject case folders, copying, filing, data entry, faxing, QC of spreadsheets and data transfer files.<br>• Complete other related duties as assigned.<br>• Ensure that Quality Events such as incidents and deviations are properly documented; support/lead the immediate remediation and preventative actions<br>• Ensure change requests are properly initiated, completed, and approved prior to the use of the assay, system, instrument, software, etc. being changed<br>• Maintain up-to-date training records and ensure training is complete prior to performing specific job functions<br>• Follow approved and effective procedures; ensure procedures accurately reflect activities being performed<br><br>This position will be located at the Carlsbad, CA site and will not have the ability to be located remotely. This position will require no travel as defined by the business (domestic and/ or international). Please note that this role would not provide relocation and only local candidates will be considered.<br><br>[#video#{#400,300#}#/video#]