Global Clinical Study Lead

IQVIA; Bloemfontein; On-site; ZAR 741,000 - 1,748,000; Full time

Job summary

IQVIA is seeking a Global Study Manager to support delivery of clinical studies within BioPharmaceuticals Clinical Operations, spanning CSP development through CSR, study setup, maintenance, and archiving.

The role requires leadership, cross-functional collaboration, and strong knowledge of ICH/GCP guidelines to ensure on-time, on-budget study delivery with high quality. Experience in pharma/clinical research and stakeholder management is essential.

Qualifications

• University degree (or equivalent) in medical or biological sciences.
• 3+ years pharma/clinical research experience.
• Knowledge of clinical development / drug development process and various phases.
• Excellent knowledge of ICH/GCP guidelines.
• Excellent communication and relationship-building skills.
• Good project management skills.
• Demonstrated ability to collaborate and work independently.
• Demonstrated leadership skills.
• Excellent written and spoken English.

Responsibilities

• Lead preparation of delegated study documents and related external provider documents.
• Maintain and facilitate interactions with CROs and external partners for efficient study delivery.
• Plan and conduct internal and external meetings (Investigators’/Monitors’ meetings).
• Ensure supply of Investigational product and study materials.
• Identify risks and develop mitigation/action plans.
• Ensure study documents are complete and verified in Trial Master File.
• Support GSD/GSAD with budget management and invoicing reconciliation.
• Adhere to ICH/GCP and global processes for inspection readiness.
• Support GSD/GSAD with overall project management.
• Manage CRO oversight for outsourced studies and ensure timelines and quality.

Skills

Leadership

Stakeholder management

Communication skills

Project management

GCP/ICH knowledge

Budget management

Cross-functional collaboration

English proficiency

Education

University degree in medical/biological sciences

Job description

IQVIA is seeking a Global Study Manager to support delivery of clinical studies within BioPharmaceuticals Clinical Operations, spanning CSP development through CSR, study setup, maintenance, and archiving.

The role requires leadership, cross-functional collaboration, and strong knowledge of ICH/GCP guidelines to ensure on-time, on-budget study delivery with high quality. Experience in pharma/clinical research and stakeholder management is essential.