Job Description
Veranex’s mission as an Innovation CRO is to improve patient outcomes by accelerating our clients’ innovations to market. As the world’s only end-to-end professional services firm focused on MedTech, we take clients’ Vision to Velocity through our comprehensive service portfolio, with expertise in human centered design and product development, preclinical and clinical research, regulatory affairs, and market access and reimbursement consulting.
About This Role:
Veranex has an exciting opportunity to join our team as a Principal Clinical Database Programmer. You will be part of a team working to improve lives globally through medical technology innovation. The Principal Clinical Database Programmer will utilize primary database management development tools to program, validate, and maintain databases to meet specifications according to company and/or client standard operating procedures. Supports, executes, and manages the database development process through the creation, testing, and programming of the database. Performs database validation, programs and reviews edit check specifications. Collaborates cross-functionally to clarify specifications and uses technical skills to meet evolving project needs. Serves on project teams to support clinical database programming activities. Performs database quality control activities and quality control on electronic submission documents to meet FDA and client specifications and to achieve and maintain high data quality. Reviews protocol and query preparation on protocol.
What You Will Do:
• Ensures high quality deliverables by providing senior review of study level/program level/multi-study core deliverables for accuracy.
• Assists with internal audits and attends sponsor audits.
• Participates in risk-based monitoring model and the Randomizationand Trial Supply Management (RTSM) configuration and testing.
• Provides advanced technical expertise and support to the clinical database programming and data management teams.
• Provides leadership, training, guidance, and support to other programmers.
• Manages and leads projects and clinical database programming team on single or multiple projects.
• Manages clinical database programming and resourcing requirements to meet timelines.
• Works on Protocol Interpretation, design and review of eCRF, the writing and reviewing of Edit check specification, programming edit check, configure database, Postproduction changes, and takes part in EDC and related module Evaluation.
• Participates in business development activities. Attends project and departmental review meetings.
Qualifications:
Required skills:
• Bachelor’s degree or international equivalent in computer science or related field.
• 5 - 8 years of relevant work experience
• Having wide-ranging experience, uses professional concepts to resolve complex issues in creative and effective ways.
• Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
• Exercises judgment in selecting methods, techniques, and evaluation criteria for obtaining results.
• Networks with key contacts outside area of expertise.
Preferred:
• In-depth knowledge of clinical research and the drug development process
• Advanced knowledge of medical terminology, Good Clinical Practices (ICH GCP), CDASH, and CDISC
• In-depth knowledge of databases, validation, programming, word-processing and spreadsheet software
• In-depth knowledge of programming languages
• Advanced programming skills
• Excellent written and oral communication skills
• Excellent attention to detail
• Ability to solve complex problems
• Advanced ability to effectively manage multiple tasks and projects
• Ability to lead and coordinate small teams.
Veranex is an equal opportunity employer and prohibits discrimination of any kind. All qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy, gender identity or gender expression), sexual orientation, parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic origin, or any other applicable legally protected characteristics.
