Clinical Data Specialist

IQVIA LLC; Bloemfontein; Sur place; ZAR 250 000 - 360 000; Plein temps

Résumé du poste

IQVIA LLC is seeking a Database Validation Specialist in Bloemfontein to ensure high-quality clinical databases. You will lead validation and audit activities, test trial databases, maintain the DMP, and drive continuous process improvements within the team.

The role requires a Bachelor’s degree in clinical/biological/mathematical sciences, medical terminology exposure, and strong organizational and leadership skills. You will mentor teammates and liaise with CDM stakeholders across projects.

Qualifications

• Bachelor's degree in clinical, biological or mathematical sciences or equivalent
• Medical terminology exposure
• Excellent organizational, communication, leadership and computer skills
• Attention to detail and ability to work independently
• Ability to establish and maintain effective working relationships with coworkers, managers and clients

Responsabilités

• Provide expertise in validation tasks and perform database validation to ensure high-quality databases.
• Lead database audit activities and oversee validation across studies.
• Ensure quality, accuracy, and timely delivery of validation activities.
• Test clinical trial databases and review/edit database specifications as required.
• Create, document and maintain test cases within the Data Management Plan (DMP).
• Reconcile Edit Check status prefixes using DMP reconciliation reports.
• Escalate document updates, discrepancies and uncertainties to the Lead Data Manager.
• Maintain compliance with SOPs, quality standards and work instructions.
• Establish relationships with CDM teams and stakeholders; drive process improvements.
• Provide end-to-end project management for testing activities including resources and timelines.
• Mentor and train new team members; act as SME for database validation and testing.

Connaissances

Attention to detail

Leadership

Communication

Independent work

Medical terminology

Formation

Bachelor's Degree in Clinical/Biological/Mathematical Sciences

Outils

SQL

SQL/Data querying

Description du poste

Job Overview

Essential Functions

• Provide expertise in validation tasks and perform database validation activities to ensure delivery of high-quality clinical databases.
• Lead database audit activities and oversee validation efforts across assigned studies.
• Take accountability for the overall quality, accuracy, and timely delivery of database validation activities.
• Test clinical trial databases and review/edit database specifications as required.
• Create, document, and maintain test cases within the Data Management Plan (DMP).
• Reconcile Edit Check status prefixes using DMP reconciliation reports.
• Update Edit Check statuses within the Data Management Plan and Clinical Trial Database (CTDB) as applicable.
• Identify and communicate erroneous Edit Checks to database programmers for correction.
• Escalate document updates, discrepancies, and uncertainties to the Lead Data Manager.
• Ensure compliance with all core operating procedures, quality standards, and work instructions.
• Establish and maintain strong working relationships with Clinical Data Management (CDM) teams and cross-functional stakeholders.
• Drive continuous process improvement initiatives and support organizational change efforts across the portfolio.
• Apply advanced knowledge of database structures, validation methodologies, and testing processes.
• Provide support to the Testing Lead and contribute to project documentation and stakeholder communications.
• Act as deputy or backup for the Testing Lead when required.
• Serve as a Subject Matter Expert (SME) for database validation and testing activities.
• Mentor, train, and support onboarding of new team members.
• Attend and actively contribute to project and study team meetings.
• Review project plans and proactively identify, elevate, and mitigate risks and issues.
• Provide end-to-end project management for testing activities, including resource planning, workload management, and delivery oversight.
• Monitor project timelines and ensure testing deliverables are completed within agreed deadlines.
• Conduct quality reviews and audits to ensure compliance with study requirements and regulatory standards.
• Develop and maintain strong relationships with internal customers and key stakeholders.
• Support risk management activities by identifying potential challenges and escalating concerns to management.
• Contribute to process optimization and implementation of best practices within the testing and validation function.
• Ensure accurate documentation, tracking, and reporting of testing outcomes and validation findings.
• Support successful database build, testing, deployment, and maintenance activities throughout the clinical trial lifecycle.

Qualifications

• Bachelor's Degree Clinical, biological or mathematical sciences, or related field Equivalent combination of education, training and experience in lieu of degree.
• Medical terminology exposure.
• Excellent organizational, communication, leadership and computer skills.
• Ability to exercise excellent attention to detail.
• Ability to act independently and with initiative required to resolving problems.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Medical terminology exposure.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.