Consultant at Warman O’Brien | Medical Affairs | UK & Europe
Clinical Study Manager/Senior Clinical Study Manager
Location: Dublin (Hybrid, 2-3 days on site)
These roles will lead the planning, execution, and oversight of global Phase II–III clinical studies, ensuring delivery to the highest standards of GCP, regulatory compliance, quality, and operational excellence.
You’ll take ownership of day-to-day study management, from start‑up through close‑out, providing leadership across internal teams, CROs, vendors, and global functional partners. The Senior role offers additional autonomy, managing more complex programs and contributing to continuous improvement initiatives across Clinical Operations.
Key Responsibilities
* Oversee all aspects of clinical study execution from initiation to database lock.
* Provide strong CRO and vendor oversight, ensuring on-time delivery, budget adherence, and quality outcomes.
* Lead and coordinate cross‑functional study teams, including Clinical Development, Data Management, Regulatory, and Quality.
* Support protocol development, study timelines, and operational strategies.
* Review study plans, monitoring reports, and trial master file (TMF) quality.
* Contribute to inspection readiness, audit preparation, and CAPA management.
* Participate in training, investigator meetings, and vendor governance reviews.
* Drive process improvements and consistency across global studies.
About You
* 5‑8 years’ experience in Clinical Research, including at least 2 years in a study management or leadership role (Senior level: 8+ years with 2‑5 years in study leadership).
* Proven ability to lead and oversee global outsourced studies (Phase II–III).
* Strong vendor and CRO management experience, including KPIs, budgets, and quality metrics.
* Excellent understanding of ICH‑GCP, global regulatory standards, and TMF requirements.
* Skilled in cross‑functional leadership, with a hands‑on, solution‑oriented approach.
* Advanced communication, planning, and decision‑making skills.
* Bachelor’s degree in Life Sciences or related field (Master’s preferred).
Why Join?
* Join a growing Dublin team with international visibility and influence.
* Opportunity to work on global, high‑impact studies with strong leadership support.
* Collaborative, inclusive culture where your ideas can shape how studies are run.
* Competitive salary, pension matching, private medical insurance, and education support.
* Clear pathways for career development and internal progression.
* Hybrid working model with flexibility to balance home and office collaboration.
Please apply ASAP if these roles sound interesting to you.
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