Project Manager – Non-Interventional Study (Client Dedicated)

About the role

The Project Manager serves as the lead and primary sponsor contact, accountable for delivering quality, time, and cost objectives on behalf of the organization. The role involves guiding a cross‑functional team, managing customer expectations, and ensuring compliance with regulatory and internal policies.

Key responsibilities

• Act as the primary liaison between the sponsor and the organization, maintaining clear escalation pathways.
• Define responsibilities and communication routes for secondary leads (regional, vendor, or delivery subsets).
• Oversee overall project delivery, ensuring adherence to schedule, budget, and quality standards.
• Maintain financial stewardship by understanding contracts, aligning resources to budget, managing out‑of‑scope activities, and driving the Con Mod negotiation process.
• Set and communicate customer expectations to achieve optimal delivery.
• Identify risks and resolve issues using RBQM/RESOLVE methodologies.
• Ensure team compliance with organizational policies, SOPs, ICH‑GCP, and other regulatory requirements.

Required profile

• Bachelor’s degree or equivalent with at least 8 years of relevant experience.
• Prior experience managing Non‑Interventional Studies (NIS) and leading cross‑functional project teams.
• Strong understanding of project management principles (time, cost, quality) and solid financial acumen.
• Advanced therapeutic‑area knowledge and familiarity with clinical development guidelines.

Required skills

• Proficiency with Microsoft Outlook, Word, Excel, and PowerPoint.
• Experience using clinical trial management systems such as CTMS, Preclarus, and Clarity.