Senior Quality Review Specialist (Principal Data Manager)
- Employer: IQVIA
- Location: Bloemfontein
- Employment Type: Full-Time (Home-Based)
- Job Reference: R1553171
Job Overview
The Senior Quality Review Specialist (Principal Data Manager) is a senior-level leadership role responsible for overseeing data management operations across multiple global clinical trials and laboratory studies. The position ensures high-quality, accurate, and compliant clinical data from study start-up through database lock while leading teams, managing client relationships, budgets, timelines, and quality standards.
Key Responsibilities
Data Management Leadership
- Serve as Data Team Lead (DTL) on 6–10 global clinical trials or 40+ complex central laboratory studies.
- Lead and mentor Clinical Data Management (CDM) teams.
- Provide technical expertise and guidance on data management processes.
- Act as a Subject Matter Expert (SME) in specialized data management areas.
Project and Operational Management
- Oversee the full data management lifecycle from study start-up to database lock.
- Manage project timelines and deliverables.
- Monitor project quality and compliance.
- Manage resources effectively across multiple projects.
- Oversee Scope of Work (SOW) and project budgets.
Client and Stakeholder Management
- Build and maintain strong customer relationships.
- Lead customer negotiations regarding timelines, budgets, and project requirements.
- Participate in bid defense meetings and business development activities.
- Deliver marketing and capability presentations to prospective clients.
Quality Assurance and Process Improvement
- Ensure comprehensive quality control procedures are implemented.
- Identify and implement process improvements.
- Develop project solutions and recommend best practices.
- Support the development of new technologies and tools.
- Review and contribute to operating procedures and work instructions.
Team Development and Mentorship
- Mentor and train team members.
- Develop data management expertise within the department.
- Lead focus groups and best-practice initiatives.
- Support continuous professional development across teams.
Industry Contribution
- Present at professional conferences.
- Publish articles in professional journals.
- Contribute to the advancement of clinical data management practices.
Minimum Requirements
Education
One of the following qualifications is required:
- Bachelor’s Degree in:
- Clinical Sciences
- Biological Sciences
- Mathematical Sciences
- Related scientific field
OR
- Nursing qualification with relevant experience.
Experience
- Minimum 5 years of relevant clinical data management experience.
- Proven experience managing multiple projects simultaneously.
- Experience managing large clinical trials involving more than 1,000 patients.
- Experience leading customer negotiations and bid defense meetings.
- Experience across the complete clinical data management lifecycle.
Required Knowledge and Skills
Technical Expertise
- Advanced clinical data management knowledge.
- Understanding of clinical drug development processes.
- Experience with SAE (Serious Adverse Event) reconciliation.
- Central laboratory data management expertise.
- Knowledge of emerging technologies within clinical research.
- Strong understanding of operating procedures and work instructions.
Leadership Skills
- Team leadership and mentoring.
- Strategic decision-making.
- Resource management.
- Project management.
- Stakeholder management.
Professional Competencies
- Excellent organizational skills.
- Advanced communication and presentation skills.
- Strong analytical and problem-solving abilities.
- High attention to detail.
- Ability to build strong client and team relationships.