Eileen Feeley
Farmingdale,USA
Summary
Results-driven professional in Clinical Trial Management and Project Management with extensive experience overseeing Class III implantable medical device trials. Proven expertise in managing Phase II, IIa, III, and III-B pharmacology and in-vitro diagnostic clinical trials. Strong knowledge of GCP and regulatory processes, complemented by significant experience in audit and BIMO support across various therapeutic areas including cardiovascular, oncology, and neurology. Registered Nurse with a current New York State Nursing License and certification as a Clinical Research Professional (CCRP) from SoCRA.
Overview
31
31
years of professional experience
1
1
Certification
Work History
Clinical Operations Leader/Clinical Trial Manager
Parexel international
07.2023 - Current
- Oversaw execution of clinical trial operations, ensuring adherence to protocols, timelines, and budgets.
- Collaborated with project leaders and cross-functional teams to optimize trial processes.
- Managed site activation, patient recruitment, and closure for efficient site performance.
- Created and reviewed study documents, including protocols and study plans.
- Tracked timelines and milestones, providing regular updates to stakeholders.
- Identified potential risks, implementing mitigation strategies for successful trial completion.
- Ensured compliance with GCP guidelines and relevant regulations in all activities.
- Maintained budget control, optimizing resource allocation throughout the trial.
Senior Clinical Trial Manager
ICON PLC Clinical Research Organization
09.2020 - 07.2023
- Oversaw delivery of clinical aspects for research studies, including monitoring plans and training documentation.
- Managed study start-up, site activation, enrollment, and tracking of study supplies.
- Ensured adherence to GCP, regulations, protocol compliance, and study manuals.
- Supervised clinical budgets, site payments, and vendor management for study sites.
- Monitored CRA performance and site schedules; reviewed trip reports and travel expenses.
- Identified and mitigated study risks; reviewed protocol deviations and implemented corrective actions.
- Served as primary contact for project management, sponsors, cross-functional teams, and clinical sites.
Clinical Affairs Project Manager
Siemens Healthineers, INC
02.2020 - 09.2020
- Managed independent start-up activities for IVD clinical studies, including Clinical Protocol development and ICF creation.
- Developed Clinical Study Plans, Data Management Plans, and Statistical Analysis Plans.
- Oversaw CRF development, including UAT testing and Investigational Product supply management.
- Created study budget and contract negotiations, including contracts, budgets, and NDAs with clinical sites.
- Led the development and review of monitoring documents, training materials, and regulatory documentation.
- Ensured execution of clinical studies within timelines while overseeing budget and CRO negotiations.
- Collaborated cross-functionally with Quality colleagues, Regulatory Affairs, and Quality Systems regarding GCP expertise and clinical processes.
- Assisted in preparation and submission of Pre-Submission for 510K.
Associate Manager Clinical Monitoring; Clinical Trial Lead
Edwards Lifesciences, LLC
03.2013 - 02.2020
- Led clinical trial projects with over 1000 subjects, ensuring alignment with regulatory submission goals.
- Collaborated with project managers and cross-functional teams to achieve trial objectives and deliverables.
- Provided guidance to oversee clinical trial conduct, ensuring compliance and data integrity across timelines.
- Contributed to the development of clinical protocols, informed consent forms, and standardized project documents.
- Developed technical training on GCPs, protocols, and regulatory requirements for new employees.
- Conducted protocol training and mentoring for the Field Monitoring team to enhance performance.
- Directed strategic monitoring of studies, assessing documentation for consistency with study hypotheses.
- Identified and implemented process improvements through collaboration with key stakeholders.
Sr. Clinical Research Associate
Trans-catheter Heart Valve Clinical Affairs Department
05.2012 - 03.2013
- Ensured successful implementation of clinical studies per ICH/GCP guidelines and relevant SOPs.
- Conducted field monitoring and remote data collection for two investigational clinical trials.
- Developed and delivered technical training on GCPs, protocols, and regulatory documentation requirements.
- Trained investigators and study coordinators to ensure compliance with protocols and regulatory policies.
- Provided oversight of trial activities, identifying trends in compliance and data quality for stakeholders.
- Verified study data accuracy by monitoring clinical records and resolving discrepancies.
- Maintained appropriate regulatory documents to uphold validity of study information throughout trials.
Independent Contract Clinical Consultant
EBF Clinicals, LLC.
04.2009 - 05.2012
- Managed direct contracts with medical device sponsor and two CROs for cardiac and renal clinical trials.
- Oversaw compliance with protocols, timelines, and regulatory guidelines through training and evaluations.
- Conducted timely documentation and communication of adverse event reports per internal procedures.
- Ensured completion and submission of monitoring documents and all sponsor-site correspondence.
- Executed site qualification, initiation, interim monitoring, and closeout visits effectively.
- Facilitated negotiations between clinical sites and sponsor regarding informed consent forms.
- Provided guidance to investigators and coordinators to maintain study integrity.
- Performed periodic follow-ups on corrective actions identified during site evaluations.
Sr. Clinical Research Associate
IDev Technologies, Inc.
Houston, TX
04.2007 - 04.2009
- Managed 12-14 clinical investigative sites, overseeing study and regulatory documentation for each site.
- Facilitated IRB submission documentation for approval with clinical study sites.
- Designed and developed clinical protocols, informed consent forms, and study-related documents, including site selection questionnaires and visit reports.
- Developed and reviewed eCRF specifications, edit checks, and conducted UAT testing for electronic data capture systems.
- Supported Clinical Research Director in planning, implementing, and reporting clinical research studies per ICH/GCP guidelines.
- Collaborated with project teams to identify and manage clinical study risks proactively.
- Executed monitoring strategies by developing relevant study documents, including monitoring plans and SOPs for the Clinical Research Department.
- Conducted site qualification visits to ensure compliance with GCP and regulatory policies, providing necessary training to site teams.
Clinical Research Associate II
Boston Scientific Corporation
St. Paul, MN
01.2005 - 04.2007
- Ensured compliance with protocols and regulatory policies through investigator training and on-site evaluations.
- Supported project team in operational planning and execution of clinical trials.
- Submitted detailed reports of monitoring visits and communicated study-related concerns to internal staff.
- Conducted site initiation, interim monitoring, and close-out visits to maintain data integrity.
- Led protocol adherence, data collection, and monitoring efforts to support clinical studies.
- Identified and reported adverse experiences, ensuring timely documentation and communication per requirements.
- Mentored new and junior study team members to enhance organizational knowledge and performance.
Nurse Administrator/ Clinical Research Coordinator
Weill Medical College of Cornell University
New York, NY
04.2002 - 01.2005
- Nurse Administrator/Clinical Research Coordinator: Cardiac Prevention Center
Staff Nurse - Critical Care
New York Presbyterian Hospital – Cornell Campus
New York, NY
09.1998 - 04.2002
- Staff RN: Cardiac ICU
Staff Nurse - Critical Care
St. John’s Queens Hospital
Elmhurst, NY
06.1994 - 09.1998
- Staff RN: Cardiac Telemetry
Education
Bachelor of Science Nursing - Nursing – RN to BSN
Drexel University
01-2025
Associate of Science Nursing - Nursing – RN Program
Catholic Medical Center School of Nursing (Merged: Saint Paul’s School of Nursing)
05.1994
Business/Health Care Administration
St. John’s University
Skills
- Clinical trial management
- Budget oversight and site activation
- Regulatory compliance and risk assessment
- Stakeholder communication and collaboration
- Patient recruitment strategies
- Cross-functional project management
- Data analysis and performance metrics
- Team leadership and protocol development
Certification
- Certified Clinical Research Professional, SoCRA, 2011-Current
- Clinical Project Management Fundamentals Certification Program, Barnett International, 2017
- New York State Registered Professional Nurse (RN), Current
Professional Memberships
Society of Clinical Research Associates (SoCRA), 2011-current
Timeline
Clinical Operations Leader/Clinical Trial Manager
Parexel international
07.2023 - Current
Senior Clinical Trial Manager
ICON PLC Clinical Research Organization
09.2020 - 07.2023
Clinical Affairs Project Manager
Siemens Healthineers, INC
02.2020 - 09.2020
Associate Manager Clinical Monitoring; Clinical Trial Lead
Edwards Lifesciences, LLC
03.2013 - 02.2020
Sr. Clinical Research Associate
Trans-catheter Heart Valve Clinical Affairs Department
05.2012 - 03.2013
Independent Contract Clinical Consultant
EBF Clinicals, LLC.
04.2009 - 05.2012
Sr. Clinical Research Associate
IDev Technologies, Inc.
04.2007 - 04.2009
Clinical Research Associate II
Boston Scientific Corporation
01.2005 - 04.2007
Nurse Administrator/ Clinical Research Coordinator
Weill Medical College of Cornell University
04.2002 - 01.2005
Staff Nurse - Critical Care
New York Presbyterian Hospital – Cornell Campus
09.1998 - 04.2002
Staff Nurse - Critical Care
St. John’s Queens Hospital
06.1994 - 09.1998
Bachelor of Science Nursing - Nursing – RN to BSN
Drexel University
Associate of Science Nursing - Nursing – RN Program
Catholic Medical Center School of Nursing (Merged: Saint Paul’s School of Nursing)
Business/Health Care Administration
St. John’s University
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