Global Data Manager- IQVIA x1
- Position: Global Data Manager
- Company: IQVIA
- Location: Home-Based (South Africa – Bloemfontein)
- Job Reference: R1553657
- Employment Type: Full-Time Remote
- Industry: Clinical Research / Healthcare / Pharmaceutical Services
Purpose of the Role
The Global Data Manager is responsible for leading and overseeing clinical trial data management activities, ensuring high-quality clinical data collection, compliance with regulatory standards, timely project delivery, and effective collaboration with sponsors, vendors, and internal teams.
This is a senior-level position requiring leadership experience in clinical data management within pharmaceutical, biotechnology, or clinical research environments.
Key Responsibilities
Clinical Data Management Leadership
- Provide oversight and accountability for one or more clinical trials.
- Lead trial-level data management activities from study start-up to database lock and archiving.
- Act as the primary data management contact for clients and stakeholders.
Data Collection and Database Management
- Gather and define requirements for:
- Electronic Case Report Forms (eCRFs)
- Data collection systems
- Clinical datasets
- Establish data quality standards and conventions.
- Define dataset structures and content requirements.
Planning and Delivery Management
- Develop and manage:
- Data Review Plans
- Quality Control (QC) Plans
- Oversight Plans
- Database Release Plans
- Submission Plans
- Archival Plans
- Monitor timelines and ensure milestone completion.
Quality Assurance and Compliance
- Ensure data management deliverables meet regulatory standards.
- Maintain inspection readiness throughout the trial lifecycle.
- Support audits and regulatory inspections.
- Perform oversight controls and quality reviews.
Documentation and Reporting
- Create and maintain data management documentation.
- Prepare submission packages.
- Ensure documentation is accurate, consistent, and compliant.
- Produce reports and study-related deliverables.
Stakeholder Management
- Work closely with:
- Clinical teams
- Sponsors
- Vendors
- Regulatory teams
- Manage vendor relationships and deliverables.
- Facilitate collaboration across study teams.
Training and Knowledge Sharing
- Present at investigator meetings.
- Train study teams and stakeholders.
- Share lessons learned and best practices.
- Support continuous process improvement initiatives.
Minimum Requirements
Qualifications
- Bachelor’s Degree (BS/BA) or higher in:
- Health Sciences
- Life Sciences
- Clinical Research
- Or a related field
Experience
- Minimum 5 years’ Clinical Data Management experience.
- Minimum 3 years’ experience in a lead or co-lead role.
- Vendor Management experience.
- Experience working on global clinical trials.
Technical Requirements
- Strong experience with:
- Clinical Data Management systems
- Clinical trial processes
- Regulatory compliance
- Clinical databases
- Experience using Medidata RAVE is essential.
Preferred Skills
- Clinical trial oversight.
- Project management.
- Stakeholder management.
- Quality assurance.
- Regulatory inspection readiness.
Key Competencies
Leadership
- Ability to lead trial teams.
- Strong decision-making abilities.
- Project ownership and accountability.
Communication
- Excellent stakeholder engagement skills.
- Strong written and verbal communication.
- Ability to train and present information effectively.
Organisation
- Strong planning and coordination skills.
- Ability to manage multiple projects simultaneously.
- Attention to detail and compliance.
Technical Expertise
- Knowledge of clinical trial regulations.
- Data quality management.
- Clinical database management systems.
- Risk-based monitoring principles.
Compensation
Salary
R1,553,657 per annum
Work Arrangement
- Fully remote/home-based.
- Flexible working environment.
- Global collaboration opportunities.