Independently manage operational deliverables across global clinical trials, ensuring studies are executed compliantly, risks are proactively managed, and key milestones are successfully delivered through final study closure.
What Your Week Might Look Like
Driving study closure activities after database lock
Managing vendors and CROs to ensure timely study delivery
Supporting inspection readiness, audits, and CAPA activities
Monitoring budgets, accruals, and financial reconciliation
Identifying risks and implementing mitigation plans
Mentoring colleagues and contributing to process improvements
What You'll Do
Independently manage complex study deliverables and operational activities
Drive inspection readiness, compliance activities, and quality oversight
Oversee study documentation, eTMF quality, and milestone tracking
Support vendor oversight, budget management, and financial reconciliation
Partner with Global Trial Leads and stakeholders to resolve challenges
Lead or contribute to initiatives that improve study execution and efficiency
You'll Thrive If You
Take ownership and work effectively with minimal supervision
Proactively identify issues and drive solutions forward
Confidently manage multiple stakeholders and competing priorities
Understand the broader picture of clinical trial delivery
Enjoy mentoring others and sharing expertise
Balance strong attention to detail with strategic thinking
Your Background
Bachelor's degree in a scientific, healthcare, or related discipline
4-6+ years of experience in clinical trial operations or global study management
Experience managing operational deliverables across global clinical trials from study startup to study closure
Strong understanding of ICH-GCP, clinical trial regulations, and end-to-end study execution
Demonstrated ability to work independently and manage complex operational challenges
Experience as a Subject Matter Expert, mentor, trainer, or process improvement lead is highly valued
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