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.
JOB PURPOSE & IMPACT
Under supervision, this position will be performing & coordinating the delivery of data management services for multiple clinical trial 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 Specialist will ensure, accuracy and adherence to applicable regulations, GCP and GDP and support the supervisor/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 Specialist must follow study specific procedures and adherence to data management compliance and demonstrate thorough knowledge of the data management process.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Note: Other duties may be assigned.
• Works in a GMP/GCP/GLP/CLIA regulated environment and is responsible for following all applicable regulations
• Perform end-to-end delivery of data management services for multiple clinical trial projects with some guidance, ensuring quality deliverables on time
• Perform routine QC 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 correctly (e.g., quality check of source data, databases and reports as required).
• Establish strong communication with GxP team, test method leads, project managers and all other stakeholders
• Communicate with Project Managers, GxP team and technical 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
• Work with project team to identify and resolve data issues
• 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
• Reviews and verifies source materials to determine accuracy and completeness of information; follows up to correct or complete data
• Assist with identification and correction of data errors in accordance with quality assurance procedures
• Assist with study close-out activities to verify data integrity and data completeness
• With guidance, prepares data validation documents and conducts data validation testing
• Provide status updates related to project tasks to management as necessary
• Assist with preparing or reviewing work instructions.
• Assist with preparing requirement/qualification documents and qualification testing for MIRTH channels.
• Ensuring that Quality Events such as incidents and deviations are properly documented, and for supporting/owning the immediate remediation and preventative actions
• Ensuring change requests are properly initiated, completed, and approved prior to the use of the assay, system, instrument, software, etc. being changed
• Maintaining up-to-date training records and ensuring training is complete prior to performing specific job functions
• Following approved and effective procedures to perform specific job functions, and ensuring procedures accurately reflect activities being performed
Diversity & Inclusion / EEO
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.
What you'll bring to the role:
MINIMUM EDUCATION, EXPERIENCE, SKILLS
Note: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Demonstrated experience and understanding of techniques directly applicable to Clinical Trial related research (molecular and cellular biological techniques such as PCR, flow cytometry, IHC, etc.) is strongly preferred.
Education and Experience Required
• Bachelor degree with 2 years of direct Clinical Data Management experience
• Knowledge of biomarker data and clinical data related to clinical trials
• Demonstrated proficiency in data management and computer software applications (MS Word, Excel, Outlook)
Required Skill Sets & Knowledge
• Background in handling various types of laboratory generated data across various molecular and protein based platforms
• Experience in auditing clinical data for accuracy and compliance
• Knowledge of GCP guidelines and clinical trials
• Effective verbal communications skills
• Ability to focus and complete repetitive tasks for an extended period of time
• Strong time management skills
• Strong attention to detail and accurate data entry
• Flexibility and capability to multitask and meet established deadlines
• Ability to prioritize and work with minimal supervision
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. Our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected statu