Senior Clinical Trial Manager - Biotech

About the role

IQVIA Biotech is looking for a Senior Clinical Trial Manager in Centurion. Clinical Trial Managers lead clinical teams and work alongside them to bring new drugs to market faster, delivering full-service, large, multi-regional studies in line with contractual requirements, SOPs and policies. Only candidates based in the listed location with previous Global CTM experience will be considered.

Key responsibilities

• Ensure clinical delivery complies with ICH-GCP, the protocol, the contract and internal policies and SOPs
• Meet recruitment targets and put in place appropriate recruitment strategies
• Contribute to the project risk mitigation plan and manage clinical risks throughout the project lifecycle
• Monitor and oversee clinical quality, including measuring compliance and managing quality issues
• Manage clinical aspects of project finance, including Estimate at Completion (EAC), and monitor changes against the baseline EAC
• Work as the primary CTM alongside other CTMs on large global trials
• Identify the clinical stakeholder landscape and manage internal and external stakeholders
• Resourcing and talent planning of the clinical team, including project-level plans, guidance, training and regular team meetings
• Support professional development by giving feedback to line managers, and mentor new peers
• May contribute to clinical delivery strategy for business proposals, take part in bid defence, develop the Clinical Operations plan, and attend site visits

Required profile

• Bachelor's degree in health care or another scientific discipline
• Ideally at least 5 years of experience in clinical trial management, or an equivalent combination of education, training and experience
• Consolidated knowledge of project management practices and terminology
• Understanding of the clinical research industry and its environments
• Understanding of project finances

Required skills

• Knowledge of ICH-GCP and applicable local laws, regulations and guidelines
• Broad protocol knowledge and therapeutic knowledge
• Skill in applying clinical research regulatory requirements to clinical trial conduct