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 Sr Clinical Data Coordinator 1. You will be part of a team working to improve lives globally through medical technology innovation. The Sr Clinical Data Coordinator 1 will be responsible for data entry activities, quality control reviews, and identification and documentation of data issues. Executes data validation programs and reports to facilitate data review. Participates in data management activities from study set up to database lock. Generates data queries to resolve data discrepancies. Appropriately addresses responses to data queries and accurately updates the clinical data as necessary. Performs validation of edit check programs. Participates in study close-out activities through data review, query resolution, and addressing issues to lock database.
What You Will Do:
• Performs study status tracking, data entry and verification.
• Identifies data issues.
• Performs all study initiation activities, clinical data cleaning and validation activities on assigned projects.
• Maintains clinical data management related study documentation.
• Participates in setup, validation, and review of the project Risk Based Monitoring requirements.
• Assists management in ensuring quality deliverables across projects.
• Participates in audits and inspections.
• Participates in project team meetings.
• Provides leadership, training, guidance, and support to other coordinators.
• Provides constructive feedback on performance of peers to functional management.
Qualifications:
Required skills:
• Bachelor’s degree or international equivalent in Life science.
• 3 - 7 years of relevant work experience
• Developing professional expertise, applies company policies and procedures to resolve a variety of issues.
• Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Builds productive internal/external working relationships.
Preferred:
• In-depth knowledge of clinical research and the drug development process
• Strong knowledge of databases, tracking, UAT, validation, query management, electronic data capture software, programming, word processing and spreadsheet software
• Strong knowledge of organization procedures and policies and ensures actions comply.
• Strong interpersonal, written, and oral communication skills
• Excellent organization skills and attention to detail
• Strong ability to take a proactive approach to work
• Ability to solve moderate to complex problems
• Strong 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.