Associate Director/Director, Pharmacoepidemiology Project Manager

About the role

Eli Lilly Cork is looking for an Associate Director/Director, Pharmacoepidemiology Project Manager (PEPM) to lead the cross-functional study team in the development and execution of complex clinical trials. The role is accountable regionally and globally to deliver clinical milestones on time, within scope and budget, and works with Subject Matter Experts and non-GPS functions on department projects.

Key responsibilities

• Plan, execute and deliver a portfolio of pharmacoepidemiology studies, leading monthly reviews with KPIs and metrics
• Provide strategic input on study design, feasibility, analytic approaches and data sources, and align strategy with regulatory requirements and product safety needs
• Manage project scope, timeline, risk, budget and vendor oversight, entering milestones into tracking systems such as Pangea, Prism and Veeva Clinical
• Act as CRO point of contact and oversee third-party organisation (TPO) qualification, selection and oversight
• Own the Trial Master File, ensure inspection readiness, and document deviations and issues
• Drive enrollment strategy and execution, from country allocation through last patient enrolled, and partner with Regional Operations
• Coach peers and new PEPMs, share process learnings and lead continuous improvement

Required profile

• Bachelor's degree (scientific or health-related field preferred) and 5 years of clinical research or relevant experience, or an advanced degree
• Preferred: 6 years of clinical trial experience, prior site-level or affiliate experience, and knowledge of local/country regional requirements
• Ability to lead and influence without authority, work cross-culturally and communicate effectively

Required skills

• Project management methodology, processes and tools (Critical Chain, Veeva, MS Project, MS Excel, MS PowerPoint, PowerBI)
• Knowledge of Good Clinical Practice (GCP) and global/regional regulations
• Scientific and regulatory expertise to support clinical and regulatory documents and agency interactions

What we offer

• Premium workspace in Little Island with flexible hybrid working
• Healthcare, pension and life assurance benefits, subsidised canteen, onsite gym and travel subsidies
• Onsite parking, in-house people development, educational assistance and wellbeing initiatives