Clinical Data Coordinator – Novartis / Navigate Biopharma / Carlsbad
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.
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.
This position will be coordinating the delivery of data management services for multiple projects and ensuring data integrity and quality deliverables on time. The candidate will assist in the delivery of high quality data, by performing reconciliation of source documentation, data entry and routine Data QC within multiple clinical databases and information systems. The data coordinator will ensure, accuracy and adherence to applicable regulations, GCP and GDP and support the clinical data manager in establishing consistent practices. This position requires attention to detail and good organizational skills. The candidate must have the ability to establish and maintain effective working relationships with cross-functional teams. Duties may also include routine peer-to-peer quality review to ensure data integrity and contribute to process improvement. The Clinical Data Coordinator must follow study specific procedures and adherence to data management compliance and demonstrate thorough knowledge of the data management process.
• Works in a GMP/GCP/GLP/CLIA regulated environment and is responsible for following all applicable regulations
• Coordinate end-to-end delivery of data management services for multiple projects with some guidance, ensuring quality deliverables on time
• Perform routine QC of data for multiple complex projects at various stages of data handling to ensure that all data are reliable and have been processed correctly (e.g., quality check of source data, databases and reports as required).
• Establish strong communication with MIRTH team, LIMS team, test method leads, project managers and all other stakeholders
• Communicate with Project Managers, LIMS team and test method leads on a regular basis to meet data management deliverables for multiple projects and ensure milestones meet timelines and quality deliverables
• With minimal guidance, support Clinical Data Management (CDM) team with comprehensive CDM process and technical expertise in executing data projects
• Perform data remediation and other efforts related to researching and updating incomplete or missing information. Perform extraction of data and generate required reports as requested
• With guidance, ensure service and quality meet agreed upon timelines and deliverables in contract/Scope of Work (SOW)
What you will bring to the role:
• Bachelor of Science or Bachelor with 2 years of experience OR 3 year Clinical Data Management experience or Clinical Research Associate experience in lieu of degree
• Demonstrated proficiency in data management and computer software applications (MS Word, Excel, Outlook).
• Strong computer literacy and keyboard skills required, ability to work with spreadsheets (such as Excel), accuracy in data entry.
• Comprehensive data management/ QC expertise, experience in auditing clinical data for accuracy and compliance, ability to focus and complete repetitive tasks for an extended period of time
• Knowledge of GCP guidelines and clinical trials, strong attention to detail, highly experienced in performing Quality review of clinical data
• Knowledge of clinical research experience
Welcome to the future of medicine.
“The ideal location for this role is the Navigate Biopharma site located in Carlsbad, CA, but remote work may be possible. Please note that this role would not provide relocation as a result. If associate is remote, all home office expenses and any travel/lodging to specific to the Navigate Biopharma site for periodic live meetings will be at the employee’s expense. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager.”
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.