Clinical Data Specialist- IQVIA x1
Job Details
- Job Title: Clinical Data Specialist
- Company: IQVIA
- Location: Bloemfontein, South Africa
- Work Arrangement: Home-based / Remote
- Employment Type: Full-time
- Job Reference: R1572675
- Industry: Clinical Research / Healthcare Intelligence
Job Description
IQVIA is seeking a Clinical Data Specialist to provide expertise in clinical database validation and testing activities. The successful candidate will be responsible for ensuring the quality, accuracy and timely delivery of clinical databases across assigned studies.
The role involves testing clinical trial databases, maintaining test cases, reviewing database specifications, identifying and resolving data validation issues, conducting quality reviews and supporting database build, testing, deployment and maintenance throughout the clinical trial lifecycle.
The position also provides an opportunity to act as a subject matter expert, support testing leadership, mentor team members and contribute to continuous process improvement.
Key Responsibilities
- Perform database validation activities to ensure high-quality clinical databases.
- Lead database audits and oversee validation activities across assigned studies.
- Take accountability for the quality, accuracy and timely completion of validation activities.
- Test clinical trial databases and review or edit database specifications.
- 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 in the DMP and Clinical Trial Database (CTDB).
- Identify erroneous Edit Checks and communicate them to database programmers.
- Escalate document updates, discrepancies and uncertainties to the Lead Data Manager.
- Ensure compliance with operating procedures, quality standards and work instructions.
- Build effective relationships with Clinical Data Management teams and cross-functional stakeholders.
- Support continuous process improvement and organisational change initiatives.
- Apply advanced knowledge of database structures, validation methodologies and testing processes.
- Support the Testing Lead with project documentation and stakeholder communication.
- Act as deputy or backup for the Testing Lead when required.
- Serve as a Subject Matter Expert (SME) in database validation and testing.
- Mentor, train and assist with onboarding new team members.
- Participate actively in project and study team meetings.
- Review project plans and identify, escalate and mitigate risks and issues.
- Manage testing activities from end to end, including resource planning and workload management.
- Monitor project timelines and ensure testing deliverables are completed within agreed deadlines.
- Conduct quality reviews and audits to ensure compliance with study and regulatory requirements.
- Maintain relationships with internal customers and key stakeholders.
- Identify potential risks and escalate concerns to management.
- Support process optimisation and implementation of best practices.
- Maintain accurate documentation, tracking and reporting of testing outcomes.
- Support database build, testing, deployment and maintenance throughout the clinical trial lifecycle.
Requirements
- Bachelor’s degree in Clinical Sciences, Biological Sciences, Mathematical Sciences or a related field.
- An equivalent combination of education, training and experience may be considered in lieu of a degree.
- Exposure to medical terminology.
- Excellent organisational skills.
- Strong communication and interpersonal skills.
- Leadership capabilities.
- Strong computer skills.
- Excellent attention to detail.
- Ability to work independently and demonstrate initiative.
- Strong problem-solving skills.
- Ability to establish and maintain effective working relationships with colleagues, managers and clients.
Key Skills and Competencies
- Clinical data management.
- Database validation and testing.
- Clinical trial database knowledge.
- Data quality and accuracy.
- Analytical and problem-solving ability.
- Project and workload management.
- Risk identification and mitigation.
- Quality assurance and compliance.
- Excellent attention to detail.
- Communication and stakeholder management.
- Leadership and mentoring.
- Process improvement.
- Ability to work independently.
About IQVIA
IQVIA is a global provider of clinical research services, commercial insights and healthcare intelligence, supporting the life sciences and healthcare industries. The company focuses on accelerating the development and commercialisation of medical treatments and improving patient outcomes worldwide.