Ciara O’Sullivan
Summary
Clinical Research Professional with 25 years’ experience in the Pharma and Medical Device industries overseeing Interventional and Non-interventional studies, RCs and IITs across all key Therapeutic Areas. Demonstrated leadership as a functional manager for large, diverse teams, consistently driving operational excellence and business continuity through periods of significant change. Expert in overseeing complex clinical programs, resource planning, and risk management with proven ability to deliver high-quality studies on time and within budget. Recognised for onboarding and developing talent, implementing process improvements and maintaining compliance with global standards. Adept at fostering collaboration, managing transitions, and ensuring the sustained success of clinical operations.
Overview
27
27
years of professional experience
Work History
CLINICAL PROGRAM LEAD
NOVARTIS
07.2023 - Current
- Functional Manager of a team of 15 Clinical Project Managers (CPM) and Clinical Operations Specialists (COS) overseeing the planning and operational delivery of research collaborations across all therapeutic areas.
- Ensure deliverables are met according to timelines, budget, quality standards and procedures.
- Review key milestones, progress, challenges, and lessons learned. Identifying areas for improvement.
- Primary point of escalation for RC Operations team.
- Oversight and tracking of Risks and Issues, escalating if required.
- Drive excellence within the team by onboarding, training and ongoing support of team members.
- Subject Matter Expert for RCs.
- Member of the cross functional Research Collaboration Core Team within GMA.
- Lead and/or participate in process improvement workstreams, contributing to the update of SOPs, WPs, systems and other guidance. Collect feedback from the operational teams for content development.
- Contribute to Medical Affairs-wide training and communicate updates to processes.
- Functional expert in RCs supporting the RLT team - training and providing ongoing support.
- Provide support and advise to GCO and Biomedical Research on RCs.
- Resource Planning and allocation – Provide operational expertise at RC Early Planning meetings, subsequently assessing FTE requirements and overseeing assignment of operational teams to projects.
- Monitoring and reporting of KPIs. Support the preparation of GMA Portfolio reports.
- Drive the Audit Readiness Process for RCs (and previously MAPs & PSDS), ensuring teams are always audit ready. Lead operational teams in throughout the audit process. Responsible for subsequent CAPA plan implementation.
- Oversight of operational team of 7 MAP leads and COS supporting MAP and PSDS (May 2022 -May 2024). Ensured MAP and PSDS programs were implemented on time and according to regulations. Represented the MAP team at PTAB.
- Drive development of team members by assigning studies and initiatives in line with their career goals when possible.
- Effective leader of teams in multiple geographic locations and cultures (i.e. Ireland, UK, India, Prague, Czech Republic, Mexico).
- Excellent stakeholder management with External Collaboration Partners in multiple locations around the world and across teams in Novartis e.g. T&MO, Study Management & Governance, Medical, PPM, V&TPM, Medical Governance & Risk Management, Quality, Operational Excellence, Legal, Data Privacy, Safety, Finance, MACoE, Local teams.
- Proven ability to manage change while maintaining delivery and quality of studies to ensure business continuity. In 2024, the majority of the RC team, and those with the most experience, were based in Dublin and impacted by TfG. Successfully led the transition of all RCs in the portfolio, closely monitoring new team and ensured high quality operational excellence (more than 89% Currently is 93% of studies remained on track with no major quality issues). Demonstrated resilience and leadership.
- Cultivated and sustained a culture in the team that is supportive, enabling and encouraging. Positive feedback received from the Ops teams and Business Partners.
- Implemented a resource and capacity planning tool for the entire RC team optimising study assignments based on priority, experience and current capacity.
- Trained, onboarded and provided ongoing support to over 60 team members from GBS and other external FSPs in the past 5 years.
- Provided support, leadership and learning to new Clinical Program Leads as the model was rolled out to NIS and RLT teams.
- Led global operations team during a global RC process audit in Nov 2023 (“satisfactory” outcome). Implemented CAPA’s for global studies on time.
- Partnered with MEOG teams and other stakeholders in the update and roll out of SOP 8095300 V3, Handover Checklist, RC Job Aid and RACI, Third-Party Management WP, TPIAT, and FMV WP and supported NCV DMS Rollout.
- Co-created and authored the Expected Document List for NCV which is used Novartis-wide to ensure compliance.
- Mentored and coached numerous team members. Key contributor to the T&MO Graduate Program. Involved in the hiring process of team members.
- Received Individual Performance Factor bonus >100% for Exceptional Impact for the past 3 years running.
SENIOR CLINICAL PROJECT MANAGER
NOVARTIS
02.2018 - 06.2023
- Study Lead, managing the day-to-day operations of all types of RCs in alignment with timelines, budget, quality standards and procedures.
- Conducted a QC check of all RCs submitted to GMAV Pharma to ensure correct framework and classification. Liaised with global and local business owners if updates were required.
- Operational oversight of RC and MAPs & PSDS Teams (more than 20 CPM and COS in total).
- Study Lead for Systane Complete Novartis Sponsored Interventional study.
- Contributed to the establishment and maintenance of a RC Centre of Excellence to facilitate the operational excellence, monitoring, process improvement, knowledge sharing, for support and oversight of global, regional, and country RCs (BO’s, Study Leads, MGLs).
- Created more than 20 tools and templates to ensure RC Compliance, such as the Protocol Checklist, Documentation Checklist and Risk & Issue Tracker.
- Member of the RC Working Group: Contributed to the creation and rollout of SOP-8095300 V1 & V2, RC Agreement templates and participated in GMA Vision Specification and UATs.
- Led and supported the operations team with GBS RC CoE self-inspection in Jul 2022. All observations categorised as minor. Responsible for preparation and implementation of CAPA plan.
- Led the global operations team in Managed Access Program PV audit in Sep 2022.
CLINICAL RESEARCH MANAGER
BIOMEDICAL RESEARCH LTD.
04.2015 - 02.2018
- Accountable for the delivery of all clinical studies in this start-up company.
- Responsible for Interventional and Non-Interventional clinical studies, including a pivotal multicentre study in the US. Responsible for oversight of all vendors.
- Participated in medical advisory board meetings with key opinion leaders.
- Contributed to development of Clinical Study Protocols, Study Reports, and other study-specific documents.
- Contributed to the development of SOPs for clinical studies.
SENIOR PROJECT MANAGER
ICON PLC
01.2011 - 04.2015
- Delivered projects on time and within budget.
- Head of Project Management (Maternity Cover) Jan 2013 to Oct 2013. Managed, trained, and provided oversight of six project managers.
CLINICAL TRIAL ADVISOR
ICON PLC
12.2007 - 01.2011
- Conducted scientific and technical reviews of clinical trial protocols and related source materials across various therapeutic areas, primarily Oncology, Cardiovascular and Vaccines.
MEDICAL SCIENTIFIC LIAISON
UCB PHARMA
08.2006 - 12.2007
- Set up a Non-Interventional PDC study, compassionate use program and IITs in Neurology and Gastroenterology.
- Provided medical information to healthcare practitioners upon unsolicited request.
- Provided therapeutic area, pharmacovigilance and Irish Pharma Healthcare Association (IPHA) code training to sales and marketing staff.
NATIONAL CLINICAL TRIALS MANAGER
LEO PHARMA
02.2004 - 07.2006
CLINICAL RESEARCH ASSOCIATE
LEO PHARMA
02.2002 - 02.2004
- End-to-end management of phase II, III & IV trials for in line with ICHGCP, regulatory guidelines, and SOPs.
- Managed CRO for epidemiological study.
- Consulted with key opinion leaders mainly in Dermatology and Critical Care.
- Represented LEO Ireland at international investigator meetings.
- Responsible for regulatory submissions.
CLINICAL RESEARCH ASSOCIATE
GSK
02.2000 - 02.2002
- Monitored clinical trials in line with ICH GCP and SOPs (Diabetes, HIV, Respiratory disease).
- Gained IEC approval in four centres and recruited 700 patients for landmark pharmacoeconomic study in Ireland.
- Responsible for the supervision and training of other CRAs.
RESEARCH ASSOCIATE
Pfizer
08.1998 - 02.2000
- Developed and validated assays for the analysis of biologics.
Education
Bachelor of Science - Biotechnology
Dublin City University
Dublin01.1998
Professional Development
Regularly complete training and development courses in Leadership, Coaching, Project Management, Good Clinical Practice, AI training sessions, Mental Health First Aid.
Timeline
CLINICAL PROGRAM LEAD
NOVARTIS
07.2023 - Current
SENIOR CLINICAL PROJECT MANAGER
NOVARTIS
02.2018 - 06.2023
CLINICAL RESEARCH MANAGER
BIOMEDICAL RESEARCH LTD.
04.2015 - 02.2018
SENIOR PROJECT MANAGER
ICON PLC
01.2011 - 04.2015
CLINICAL TRIAL ADVISOR
ICON PLC
12.2007 - 01.2011
MEDICAL SCIENTIFIC LIAISON
UCB PHARMA
08.2006 - 12.2007
NATIONAL CLINICAL TRIALS MANAGER
LEO PHARMA
02.2004 - 07.2006
CLINICAL RESEARCH ASSOCIATE
LEO PHARMA
02.2002 - 02.2004
CLINICAL RESEARCH ASSOCIATE
GSK
02.2000 - 02.2002
RESEARCH ASSOCIATE
Pfizer
08.1998 - 02.2000
Bachelor of Science - Biotechnology
Dublin City University