Regulatory & Start-Up Specialist — Clinical Trials (SA)

IQVIA Inc; Bloemfontein; On-site; ZAR 420,000 - 640,000; Full time

Job summary

IQVIA is seeking a Regulatory and Start-Up Specialist to drive site activation, regulatory submissions, and start-up deliverables within a sponsor-dedicated environment. You will liaise with investigative sites, sponsors, and IQVIA stakeholders to ensure timely activation and compliance across regulatory milestones.

The role offers exposure to international regulatory requirements, GCP, and cross-functional teamwork, with opportunities for career growth within IQVIA's global clinical research

Qualifications

• Bachelor's Degree in Life Sciences or a related scientific discipline.
• Experience in clinical trial regulatory affairs, site start-up, site activation, or related clinical research functions.
• Strong understanding of local and international regulatory requirements, GCP, and clinical research processes.
• Experience managing regulatory documentation, contracts, and start-up deliverables.
• Excellent communication, negotiation, and problem-solving capabilities.
• Strong English communication skills.

Responsibilities

• Serve as the primary point of contact for investigative sites and internal stakeholders.
• Execute site identification, feasibility assessment, and site activation activities for studies.
• Prepare, review, and distribute regulatory documentation for completeness and compliance.
• Track and manage submissions, approvals, and essential documents (regulatory, ethics, ICFs, CTAs).
• Review, negotiate, and manage site regulatory documents, contracts and start-up deliverables.
• Maintain accurate records in internal systems and tracking tools.
• Monitor milestones and identify risks with mitigation plans.
• Provide local regulatory expertise to project teams and Site Activation Managers.
• Perform quality reviews of site documentation.
• Review site performance metrics and contribute to process improvements.
• Collaborate with sponsors and cross-functional teams to ensure start-up success.

Skills

Excellent communication

Negotiation

Problem-solving

Strong English communication

Education

Bachelor's Degree in Life Sciences or related

Job description

IQVIA is seeking a Regulatory and Start-Up Specialist to drive site activation, regulatory submissions, and start-up deliverables within a sponsor-dedicated environment. You will liaise with investigative sites, sponsors, and IQVIA stakeholders to ensure timely activation and compliance across regulatory milestones.

The role offers exposure to international regulatory requirements, GCP, and cross-functional teamwork, with opportunities for career growth within IQVIA's global clinical research