Veranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables accelerated speed to market, controlled development costs, development risk mitigation, and accelerated market viability assessment. At every stage, Veranex clients realize efficiencies in cost and time, while our comprehensive solutions unify the entire development process. Veranex partners with the world’s most influential life science and medical device companies to research, design, develop and commercialize new healthcare technologies and treatments to advance patient care.
Minimum Requirement:
• Bachelor’s degree or international equivalent in life sciences and 4-6 years of relevant work experience
• 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
• 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.
• Receives minimal guidance on day-to-day work and moderate guidance on new projects or assignments.
Roles and Responsibilities:
• Performs study status tracking, data entry and verification.
• Performs all study initiation activities, clinical data cleaning, vendor data reconciliation and validation activities on assigned projects.
• Participates in setup, validation, and review of the project Risk Based Monitoring requirements.
• Perform Offline data listings review and subject level review.
• Maintains clinical data management-related study documentation.
• Supporting LDMs in study status tracking, metrics to clients, at milestones like soft lock, interim locks and DBL.
• 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.
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
