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. #J-18808-Ljbffr
A global pharmaceutical company is looking to hire an Associate Director of Clinical Operations. Working in a hybrid model from their Dublin office (2-3 days per week onsite), you will report to the Director of Clinical Operations, and help manage a small team. Working on global studies across phases II-III, your role will be a combination of oversight and hands‑on delivery. Applicants must have a strong global clinical trial management and vendor oversight background and must have comprehensive sponsor/pharma experience. My client is prepared to consider a candidate at the Senior CTM/PM level with strong oversight experience who is looking to move into a more senior role, or someone currently at AD/Senior Manager level seeking broader scope. Role Responsibilities Oversees the clinical feasibility assessment and strategic planning of clinical trial programs or studies. Executes on these global programs or studies in one or more assigned therapeutic area(s) from decision to start a clinical development up to the market authorisation. Manage budgets, timelines and quality of deliverables for assigned programs and studies. Oversee integrity of clinical data to ensure data meets GCP standards. Participate in cross functional project teams and presents program information to internal and external audiences. Provide clinical review/input to Investigator Sponsored Research proposals. Assess best strategic path forward for a clinical program and drive clinical strategy recommendations including timelines and cost to key stakeholders. Draft clinical components from decision to start a clinical development and up to market authorisation Liaise cross-functionally to provide clinical input on all development stages and Target Product Profile. Provide clinical status updates to the Project Management Office and to upper Management. Manage direct reports through performance evaluations and addressing professional development. Ensure compliance of each Clinical Development trial team with the trial-specific training requirements Participate and contribute to internal and external training for clinical program (e.g. Kick-off meeting, Investigator's meeting) Participate in development of vendor specifications to ensure accurate interpretation of the protocol requirements. Support the Program Manager in overseeing third party vendors performance (e.g., contract research organizations (CROs), central labs) including on time study completion, budget adherence, and quality deliverables. Contribute to the evaluation of the vendor performance to ensure early mitigation/resolution of potential issues and develops/implements corrective action plans as appropriate, along with the Program Manager. Perform Sponsor Site Visits at selected sites to oversee the site and the monitoring performances Provide clinical review/input to clinical documents (e.g., protocols, investigator brochures, periodic safety reports and clinical study reports) and ensures the accuracy and integrity of clinical data prior to submission to regulatory authorities. Draft or provide review/input for publications from clinical study data and white paper literature reviews on new products or safety questions. Participates in regulatory authority meetings. Person Specification A minimum Bachelor's degree in relevant discipline. 10+ years of clinical research experience with at least 6 years clinical trials management / leadership role, including clinical document production, trial execution and involvement in clinical trial feasibility and strategy. Advanced leadership and clinical trial/project management experience in managing study teams, vendors, and other cross-functional personnel. Advanced strategic thinking abilities for proactive planning and decisive decision making. Strong ability to set and meet deadlines, multitask, and prioritise based on program and/or study needs. Advanced ability to facilitate and/or present at departmental, study, project and investigator meetings. For additional information and a confidential discussion, please apply now with an updated CV. Dublin, County Dublin, Ireland #J-18808-Ljbffr
Principal Statistician | Global Pharma | Hybrid | Ireland We are working alongside a leading global pharmaceutical company that has an opportunity for a Principal Statistician to join their team. The Role You will play a key role in designing clinical studies, developing statistical analysis plans, and delivering high‑quality insights to support regulatory submissions, publications, and business decisions. This is a leadership position where you’ll collaborate closely with physicians, scientists, and research associates, while also driving innovation in statistical methodology. What you will be doing Design and analyse clinical trials, selecting appropriate statistical methods. Lead development of protocols, data analysis plans, and reporting databases. Communicate study results through submissions, presentations, and publications. Provide statistical leadership across projects and mentor colleagues. Stay up to date with advances in statistical methodology and regulatory standards. What you’ll need M.S. or Ph.D. in Statistics/Biostatistics. Proficiency in statistical programming (e.g. SAS, R). Strong teamwork, leadership, and communication skills. Experience in regulatory submissions and clinical trial design. Problem‑solving mindset with creativity and innovation. What’s in it for you Relocation support. Career growth opportunities with a global leader. Onsite perks: gym, subsidised canteen, parking & wellbeing programs. Inclusive, diverse workplace culture. To apply, send your CV or reach out directly for a confidential chat at jo@warmanobrien.com #J-18808-Ljbffr
2 days ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. Direct message the job poster from Warman O'Brien Warman O’Brien is exclusively retained by a global pharmaceutical company to lead the search for a Senior Director of Biometrics. The role is to lead and develop a growing statistics function at their Cork hub in Ireland. This is a rare opportunity to take on a strategic leadership role that blends team coaching, technical oversight, and global portfolio support—within a group that functions like a small biotech inside one of the world’s leading pharmaceutical companies. About the Role Lead and mentor a multi-functional team (Statisticians, Stat Programmers, Data Managers) Shape the group's future structure—including the development of new group leaders Provide strategic input across all therapeutic areas, supporting global clinical development Represent the Cork site within their global statistical leadership team Engage in resource planning, gap analysis, and stakeholder communication Play a central role in educating cross-functional colleagues on statistics and clinical trial design Contribute to a collaborative, high-impact environment that works on their most exciting assets Qualifications PhD (required) in Biostatistics, Statistics, Epidemiology, or a related quantitative field Required Skills Proven experience in line management, coaching, and team-building Ability to communicate statistical value across a matrixed organization Experience in stakeholder management, internal networking, and strategic resource planning Preferred Skills Bonus: Industry engagement, publication history, and regulatory submission experience Pay range and compensation package Competitive Salary and Benefits Package and to live in one of the best cities/counties in Ireland Application If this opportunity is of interest, please apply now with your CV or a LinkedIn profile. The organization is looking to welcome the Senior Director of Biometrics onboard as soon as possible. Not what you’re looking for? Please contact Mark O’Brien on 0203325 5075 or email mark@warmanobrien.com for a confidential discussion about potential opportunities. #J-18808-Ljbffr
Overview Senior Director – Biometrics – Ireland - Hybrid Warman O’Brien is exclusively retained by a global pharmaceutical company to lead the search for a Senior Director of Biometrics. The role is to lead and develop a growing statistics function at their Cork hub in Ireland. This is a strategic leadership opportunity that blends team coaching, technical oversight, and global portfolio support within a group that functions like a small biotech inside one of the world’s leading pharmaceutical companies. What You’ll Do Lead and mentor a multi-functional team (Statisticians, Stat Programmers, Data Managers) Shape the group\'s future structure—including the development of new group leaders Provide strategic input across all therapeutic areas, supporting global clinical development Represent the Cork site within the global statistical leadership team Engage in resource planning, gap analysis, and stakeholder communication Play a central role in educating cross-functional colleagues on statistics and clinical trial design Contribute to a collaborative, high-impact environment that works on their most exciting assets What We’re Looking For PhD (required) in Biostatistics, Statistics, Epidemiology, or a related quantitative field Proven experience in line management, coaching, and team-building Ability to communicate statistical value across a matrixed organization Experience in stakeholder management, internal networking, and strategic resource planning Bonus: Industry engagement, publication history, and regulatory submission experience Why This Role? Help shape the future of the Cork statistics hub A clear runway to grow into a global statistical leader Flexible hybrid working model (approx. 2–3 days on site weekly) Opportunity to contribute to the global portfolio by engaging in strategically selected, high-impact projects Sponsorship and relocation on offer Competitive Salary and Benefits Package and to live in one of the best cities/counties in Ireland What to do next If this opportunity is of interest, please apply now with your CV or a LinkedIn profile cover as the organisation are looking to welcome the Senior Director of Biometrics onboard as soon as possible. Not what you’re looking for? Please contact Aimee Weston for a confidential discussion about potential opportunities. aimee@warmanobrien.com Additional Details Seniority level: Executive Employment type: Full-time Job function: Analyst, Training, and Management Industries: Pharmaceutical Manufacturing, Biotechnology Research, and Research Services Referrals increase your chances of interviewing at Warman O\'Brien by 2x Get notified about new Director of Biometrics jobs in County Cork, Ireland . #J-18808-Ljbffr
