IQVIA Laboratories is a leading global provider of clinical research services, and they are seeking a Clinical Study Start-Up Manager to join their team. The role involves leading the design, configuration, and launch of clinical research studies while ensuring high-quality deliverables and coordinating cross-functional teams to support business growth initiatives.
Responsibilities:
- Lead the design and management of study database configuration for full protocols, amendments, and sponsor-driven changes
- Develop and maintain sponsor and client database design standards in alignment with clinical protocols
- Coordinate and oversee study start‑up activities with internal teams and external stakeholders to ensure milestone achievement
- Manage project documentation including timelines, status reports, and action and issue logs during the start‑up phase
- Proactively identify scope changes and risks, and implement mitigation and contingency plans
- Provide day‑to‑day guidance, mentoring, and training support to junior team members
- Represent study start‑up activities in investigator meetings, kick‑off meetings, audits, and bid defense presentations
Requirements:
- Bachelor's degree in science or a related field
- Hands‑on experience with clinical study database configuration and study start‑up processes
- Proficiency with Clinical Trial Management Systems and Microsoft Office applications
- Demonstrated experience managing Phase I–IV clinical trials
- Strong leadership, communication, and stakeholder management skills
- Excellent organizational skills with the ability to manage multiple priorities and meet deadlines
- High attention to detail with a solid understanding of medical and clinical research terminology