Mycobacteriology Development Lead

About the role

The Mycobacteriology Development Lead at IQVIA in Centurion is responsible for the operational delivery of clinical research projects. The role acts as a key contact for internal and external business relationships, manages the design and launch of complex, non-standard clinical studies, reviews and improves Project Services processes, and mentors the Project Services team.

Key responsibilities

• Study setup and planning: lead protocol and budget reviews, develop project plans and logs, partner with the Study Setup team on database set-up, and present protocol materials at kick-off and investigator meetings
• May take part in proposals and bid defence meetings, develop customer standards and lead customer meetings
• Monitor project plans, timelines and deliverables, manage study documentation (including eTMF filing), oversee monitoring and reporting, and handle scope and budget changes
• Build and own the customer relationship, act as escalation point for study and program issues, run customer surveys and health checks, and represent the company at investigator meetings and audits
• Train sites, CRAs and customers, and give feedback on team performance to management
• With experience, lead global customer programs, own processes such as customer-specific training and SOPs, and mentor and train others

Required profile

• Bachelor's degree in Life Sciences or a related field, or an equivalent combination of education, training and experience
• 5+ years of clinical or research industry experience, including 3 years in project management or project set-up
• Thorough knowledge of Project Management processes and central laboratory operations (kits, supplies, logistics, specimen storage, data reporting, site alerts)
• Experience leading large, global, complex Phase I-IV clinical trials preferred
• Excellent interpersonal and customer management skills, strong written and verbal English, and local language preferred in some geographies

Required skills

• Demonstrated computer proficiency with Microsoft Office and company systems, or similar centralized laboratory systems
• Ability to work in a fast-paced environment and meet deadlines