Clinical Operations Manager – Regulatory (IQVIA)
Job Details
- Company: IQVIA
- Position: Clinical Operations Manager – Regulatory
- Location: Bloemfontein, South Africa
- Employment Type: Full-time
- Workplace Type: Hybrid
- Job Reference: R1571529
- Industry: Clinical Research / Healthcare
- Company Overview: IQVIA is a global provider of clinical research services, healthcare intelligence and commercial insights to the life sciences and healthcare industries.
Job Overview
The Clinical Operations Manager – Regulatory will be responsible for the performance, compliance and delivery of assigned clinical trial protocols within the country.
The role focuses on ensuring compliance with ICH/GCP requirements, country regulations, sponsor policies, quality standards and adverse event reporting requirements. The position also oversees country submissions and regulatory approvals, budgets, financial activities and study start-up requirements to ensure sites are ready to begin clinical trials.
Key Responsibilities
Clinical Trial & Regulatory Management
- Execute and oversee country clinical trial submissions and regulatory approvals.
- Interact with IRBs/IECs and Regulatory Authorities for assigned protocols.
- Ensure country deliverables, timelines and results meet protocol commitments.
- Maintain quality and compliance across assigned country protocols.
- Develop local-language materials, including informed consent documents and translations.
- Contribute to the development of local SOPs.
- Oversee Clinical Trial Agreements (CTAs), where applicable.
Budget & Financial Management
- Take ownership of country and site budgets.
- Develop, negotiate and complete Clinical Trial Research Agreements (CTRAs).
- Track clinical research-related payments.
- Reconcile payments at study close-out.
- Maintain relevant financial systems.
- Ensure agreed payment timelines and budget targets are met.
Country Operations & Study Start-Up
- Coordinate country deliverables required for submissions, budgets, CTRAs and local milestones.
- Work closely with Project Managers, CTAs and CRAs to coordinate country activities.
- Collaborate with headquarters to align country timelines.
- Support site readiness and country-specific trial commitments.
- Provide oversight and support to local vendors.
- Coordinate clinical and ancillary supplies, including importing, exporting and destruction requirements.
- Oversee local electronic and hard-copy filing, archiving and retention requirements.
- Manage applicable insurance processes.
- Maintain country information in clinical and financial systems.
Compliance & Stakeholder Management
- Maintain local regulatory and financial compliance.
- Influence and coordinate with investigators, external partners and country operations.
- Work with finance, regulatory affairs, pharmacovigilance, legal and regional operations teams.
- Collaborate with headquarters functional teams, vendors, clinical sites, IRBs/IECs and Regulatory Authorities.
- Support the delivery of contracts in accordance with applicable fair-market-value requirements.
Team Contribution & Continuous Improvement
- Lead or contribute to initiatives and projects that add business value.
- Act as a process Subject Matter Expert (SME) where appropriate.
- Share best practices and recommend process improvements.
- Provide training and knowledge-sharing where required.
- Support colleagues as a buddy or mentor.
Key Skills & Competencies
- Clinical trial country operations.
- Regulatory submissions and approvals.
- Clinical research compliance.
- ICH/GCP requirements.
- Budget and financial management.
- Clinical Trial Research Agreements.
- Stakeholder and vendor management.
- Study start-up and site readiness.
- Regulatory authority and IRB/IEC interaction.
- Clinical documentation and filing.
- Cross-functional collaboration.
- Process improvement and knowledge sharing.