Senior Regulatory & Start-Up Lead – Clinical Trials (SA)

IQVIA Inc; Bellville; On-site; ZAR 600,000 - 900,000; Full time

Job summary

IQVIA Regulatory and Start-Up Specialist role supports sponsor-driven site activation, coordinating regulatory submissions, ethics approvals and start-up deliverables to accelerate study initiation. You will work within sponsor-dedicated environments, ensuring compliance and timely milestone delivery across global trials.

As part of IQVIA's CFSP framework, you’ll collaborate with Site Activation Managers and cross-functional teams to navigate local and international requirements, GCP standards,

Qualifications

• 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, Site Activation Managers, Project Managers and internal stakeholders.
• Execute site identification, feasibility assessment, and site activation activities for assigned clinical studies.
• Prepare, review, and distribute regulatory documentation to ensure completeness, accuracy, and compliance.
• Track and manage submission, approval, and execution of essential documents, including regulatory submissions (if applicable for country/region), Ethics Committee submissions, Informed Consent Forms (ICFs), Investigator Pack release documentation, and Clinical Trial Agreements (CTAs).
• Review, negotiate, and manage site regulatory documents, contracts, and associated start-up deliverables.
• Maintain accurate records within internal systems and tracking tools.
• Monitor project milestones and proactively identify risks and 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 continuous process improvement initiatives.
• Collaborate closely with sponsors and cross-functional teams to ensure successful study start-up and site activation delivery.

Skills

Excellent communication

Negotiation

Problem-solving

Strong English communication skills

Education

Bachelor's Degree in Life Sciences

Job description

IQVIA Regulatory and Start-Up Specialist role supports sponsor-driven site activation, coordinating regulatory submissions, ethics approvals and start-up deliverables to accelerate study initiation. You will work within sponsor-dedicated environments, ensuring compliance and timely milestone delivery across global trials.

As part of IQVIA's CFSP framework, you’ll collaborate with Site Activation Managers and cross-functional teams to navigate local and international requirements, GCP standards,