Senior Decentralized Clinical Trial Study Lead

About the role

IQVIA is hiring a Senior Decentralized Clinical Trial Study Lead (DCTL) in Bloemfontein. DCTLs are central to clinical trial delivery, improving patients' lives and bringing therapies to market faster. The role covers studies from fully decentralized trials to hybrid studies that involve liaison with traditional project delivery teams, and requires collaboration across technology and IT, mobile nursing, site support services, regulatory and site startup teams.

Key responsibilities

• Own the strategic development and delivery of DCT studies in line with agreed contracts, optimizing speed, quality and cost, and ensuring compliance with system updates, standard processes and policies.
• Serve as the DCT project oversight and contact with customers, and lead the relationship with the project's key customer contacts.
• Set objectives for the project team, communicate and assess performance, give feedback and provide leadership.
• Collaborate with functional groups to develop and support integrated study management plans, manage study issues and obstacles, and monitor progress against the contract.
• Manage risk, contingencies and quality issues, including corrective and preventative actions, and ensure project profitability through resource management.
• Forecast opportunities to accelerate milestones and revenue, manage scope changes and change control, and share lessons learned and best practices.
• May lead bid defense presentations for virtual studies, act as a change advocate, mentor project team members, train partners on DCT processes, and take part in executive committees.

Required profile

• Bachelor's degree in life sciences or a related field.
• 5 years of relevant clinical research experience, or an equivalent combination of education, training and experience.
• Knowledge of clinical trial conduct and applicable regulatory requirements such as ICH GCP and local laws and guidelines; broad protocol and therapeutic knowledge desired.
• IQVIA core competencies: client focus, collaboration, communication, innovation and ownership.

Required skills

• Advanced knowledge of project management methodologies, ideally in clinical research.
• Strong written and verbal communication, presentation, negotiation and customer management skills, with good command of English.
• Good software and computer skills, including Microsoft Word, Excel and PowerPoint.
• Ability to work across geographies and cultures, and to manage project finances and contractual obligations.