Cardiac Clinical Data Validation Lead

Dushanbe International Hospital; Cape Town; On-site; ZAR 600,000 - 900,000; Full time

Job summary

IQVIA in Cape Town seeks a qualified professional to lead validation and testing for clinical trial databases. You will validate databases, drive audits, and ensure timely, high-quality delivery across studies, while mentoring staff and aligning with CDM teams.

Strong medical terminology exposure and project management skills are required for success. The role focuses on end-to-end validation activities, documentation within the DMP, and continuous process improvement within the testing and

Qualifications

• Bachelor's degree in clinical, biological or mathematical sciences or related field.
• Equivalent combination of education, training and experience in lieu of degree.
• Medical terminology exposure.

Responsibilities

• Provide expertise in validation tasks and perform database validation activities.
• Lead database audit activities and oversee validation across studies.
• Take accountability for the overall 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.
• Update Edit Check statuses within the Data Management Plan and 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 core SOPs, quality standards, and work instructions.
• Establish and maintain strong relationships with CDM teams and stakeholders.
• Drive continuous process improvement and support organizational change in testing.
• Provide SME guidance for database validation and testing activities.
• Mentor, train and support onboarding of new team members.
• Attend and contribute to project and study team meetings.
• Review project plans to identify, escalate, and mitigate risks and issues.
• Provide end-to-end project management for testing activities, including resource planning.
• Monitor timelines and ensure testing deliverables meet deadlines.
• Conduct quality reviews and audits to ensure regulatory compliance.
• Develop relationships with internal customers and key stakeholders.

Skills

Organizational skills

Communication skills

Leadership

Computer skills

Attention to detail

Education

Bachelor's degree in Clinical/ Biological/ Mathematical sciences

Job description

IQVIA in Cape Town seeks a qualified professional to lead validation and testing for clinical trial databases. You will validate databases, drive audits, and ensure timely, high-quality delivery across studies, while mentoring staff and aligning with CDM teams.

Strong medical terminology exposure and project management skills are required for success. The role focuses on end-to-end validation activities, documentation within the DMP, and continuous process improvement within the testing and