Clinical Data Analyst / 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.
The Clinical Data Analyst ensures the successful end-to-end operation of clinical data transfer process. The role supports the optimal planning and execution of all activities associated with data transfers. This role serves as the data management expert on multidisciplinary clinical project teams providing specific expertise on timeline development and identification of data management deliverables
• Works in a GMP/GCP/GLP/CLIA regulated environment and is responsible for following all applicable regulations
• Work with the project management, Laboratory staff and GxP Systems team on study start up activities, including data entry, database screen testing, edit/check software tool development and perform testing
• Work in conjunction with study project managers and technical laboratory staff to understand data transfer specifications and study timelines to help assess and ensure that proposed solutions satisfies requirements, timelines, broader data management and BioPharma goals.
• Work with CDM, GxP systems and Project Management teams to facilitate agreements, maintain project timelines, drive project completion, escalate issues as appropriate and maintain study data transfer deadlines.
• Communicates with Project Managers, MIRTH team, LIMS team and test method leads on a regular basis to meet data management deliverables on the multiple projects and ensures milestones meet timeline and quality deliverables
• Communicate data issues and/or query trends to Sponsor and/or project team, as appropriate
• Assess issues / generate solutions in data handling created by the changing requirements in clinical data processing.
• Escalate any potential or actual issues to supervisor, project team, and/or Sponsor in a timely manner, and follow issues through to resolution
What you will bring to the role:
• Master of Science with 1 year or Bachelor of Science with 2 years or minimum of 3 years direct Clinical Data Management or Laboratory Experience handling various types of data
• Strong background in handling various types of laboratory generated data across various molecular and protein based platforms
• Excellent verbal and written communications skills and ability to interact with personnel at all levels cross-functionally
• Ability to think critically and use good problem solving skills
• Knowledge of GxP and validation experience, Data analyst experience and Data application configuration experience
• Clinical research and clinical trial experience preferred
Welcome to the future of medicine.
The ideal location for this role is the Navigate Biopharma site located in Carlsbad, CA, but remote work within California 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.