Roberta Mooney
Egg Harbor,NJ
Summary
With 24 years of experience in the clinical research industry, as a professional that has developed a strong background and expertise in various roles. As a Clinical Research Associate, successfully managed and monitored clinical trials for over 9 years. Additionally, excelled as a Clinical Trial Manager for more than 3 years, overseeing the planning and execution of trials to ensure their success. Furthermore, 6 years as a Clinical Operations Manager has effectively lead teams and optimize operational processes. Throughout the dedicated 18 years of service to ICON Clinical Research, enhanced knowledge and understanding of the industry.
Overview
36
36
years of professional experience
Work History
Senior Clinical Operations Manager
ICON Clinical Research
04.2023 - Current
- Managed the coordination, execution, control, and completion of Clinical Operations at team level
- Managed for ensuring the delivery and development of the Clinical Operations team at site level, against key metrics and KPIs
- Provide direction and accountability for the operational teams and their delivery, and to drive execution of service and quality at the site level
- Responsibilities regarding line management, training, functional delivery and input on discussions around quality and operational delivery measurements
- To provide effective management support and coaching to team to deliver a high performing culture, and the development and engagement of the operational team
Clinical Operations Manager
ICON Clinical Research
03.2019 - 04.2023
- Responsible for the coordination, execution, control and completion of Clinical Operations at team level
- Responsible for ensuring the delivery and development of the Clinical Operations team at site level, against key metrics and KPIs
- Provide direction and accountability for the operational teams and their delivery, and to drive execution of service and quality at the site level
- Responsibilities regarding line management, training, functional delivery and input on discussions around quality and operational delivery measurements
- To provide effective management support and coaching to team to deliver a high performing culture, and the development and engagement of the operational team
Clinical Trial Manager
ICON Clinical Research
08.2015 - 03.2019
- To act as the Functional Lead from Clinical Operations with responsibility for delivery of all of Clinical Operations aspects clinical studies
- To oversee and serve as the liaison between the Project Manager and a group of Clinical Research Associates assigned to a given study for delivery of all monitoring and site management aspects of a clinical study, ensuring consistency with ICH/GCP, applicable ICON SOPs, applicable regulations, the monitoring plan and study contracts and budgets
Senior CRA
ICON Clinical Research
10.2012 - 05.2015
- Responsibilities include identification, selection, initiation, and close-out of appropriate investigational sites for clinical studies
- Monitor those sites in order to ensure that studies are carried out according to the study protocol, ICON SOPs/WPs, applicable regulations and the principles of ICH-GCP
- Involvement, when required, in other areas of study management and staff training
- Contribute to the review of ICON systems and procedures, as appropriate
- Coaching and mentoring of monitoring competence to inexperienced/less experienced colleagues
- Contribute to the culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
- Recognize, exemplify and adhere to ICON's values which center around a commitment to People, Clients and Performance
- Independently and proactively coordinate the necessary activities required to set up and monitor a study
CRA II
ICON Clinical Research
09.2008 - 10.2012
- Responsibilities include identification, selection, initiation, and close-out of appropriate investigational sites for clinical studies
- Monitor those sites in order to ensure that studies are carried out according to the study protocol, ICON SOPs/WPs, applicable regulations and the principles of ICH-GCP
- Involvement, when required, in other areas of study management and staff training
- Contribute to the review of ICON systems and procedures, as appropriate
- Coaching and mentoring of monitoring competence to inexperienced/less experienced colleagues
- Contribute to the culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
- Recognize, exemplify and adhere to ICON's values which center around a commitment to People, Clients and Performance
- Independently and proactively coordinate the necessary activities required to set up and monitor a study
CRA I
ICON Clinical Research
04.2007 - 09.2008
- Responsibilities include identification, selection, initiation, and close-out of appropriate investigational sites for clinical studies
- Monitor those sites in order to ensure that studies are carried out according to the study protocol, ICON SOPs/WPs, applicable regulations and the principles of ICH-GCP
- Involvement, when required, in other areas of study management and staff training and contribute to the review of ICON systems and procedures, as appropriate
- Contribute to the culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
- Recognize, exemplify and adhere to ICON's values, which center around a commitment to People, Clients and Performance
Study Coordinator/Pulmonary Function Tech/Respiratory Therapist
Asthma and Pulmonary Diagnostic Associates
05.2000 - 10.2006
- Responsible for all facets of pulmonary function testing
- Performed spirometry, plethesmography, DLCO, N2 washouts, MIPS/MEPS, MVV, ABGs, phlebotomy, and interpretation of pulmonary testing results
- Consulted closely with Pulmonary Physician on Pulmonary plan for patients
- Provided intensive education for patients regarding disease process and medication
- Contacted patients, pharmacies, and Physicians
- Was in charge of beta testing for medical graphics pulmonary equipment
- Maintained pulmonary equipment
- Served as pharmaceutical research coordinator, overseeing protocols, study procedures, and FDA and IRB regulations
- Therapeutic Areas: Respiratory (COPD, Emphysema, Asthma)
Registered Respiratory Therapist
Atlantic City Medical Center
08.1988 - 08.2000
- Worked as a registered respiratory therapist, specializing in acute care, trauma ICU, cardiac ICU, pediatric ICU, neonatal ICU, emergency room, and adult ICU
Education
Associate of Applied Science - Respiratory Therapy
Atlantic Community College
Mays Landing, NJ08.1988
Some College (No Degree) - Biology
Stockton State College
Pomona, NJSkills
- Site monitoring
- Clinical trial management
- Audit preparation
- GCP training
- HIPAA compliance
- Clinical documentation
- Team management
- HIPAA
- Strategic planning
- Compliance oversight
- Operations oversight
- Regulatory compliance
- Improving clinical quality outcomes
- Clinical operations planning
- Compliance with regulatory guidelines
Company
ICON Clinical Research
Personal Information
Title: Senior Clinical Operations Manager
Publications
NA
Summary
24 years research experience, 18 years at ICON Clinical, Clinical Research Associate Level 1 to Sr CRA 9 years, Clinical Trial Manager, 3 years, Clinical Operations Manager, 6 years, Therapeutic experience: Cardiovascular, III, CTM/Sr CRA, Blood and Lymphatic system disorders, CRA II, Nervous System Disorders, III, Sr CRA, Psychiatric, II, Sr CRA, Respiratory, Thoracic and Mediastinal Disorders, II,III, CRA I, Reproductive System and Breast Disorders, III, Sr CRA, Gastroenterology, IIIB/4, CTM, NA, PRM, CTMS systems DataLabs, Rave, Medidata, AddClinical, Inform, OCRDC (ICON and Pfizer systems), English
Timeline
Senior Clinical Operations Manager
ICON Clinical Research
04.2023 - Current
Clinical Operations Manager
ICON Clinical Research
03.2019 - 04.2023
Clinical Trial Manager
ICON Clinical Research
08.2015 - 03.2019
Senior CRA
ICON Clinical Research
10.2012 - 05.2015
CRA II
ICON Clinical Research
09.2008 - 10.2012
CRA I
ICON Clinical Research
04.2007 - 09.2008
Study Coordinator/Pulmonary Function Tech/Respiratory Therapist
Asthma and Pulmonary Diagnostic Associates
05.2000 - 10.2006
Registered Respiratory Therapist
Atlantic City Medical Center
08.1988 - 08.2000
Associate of Applied Science - Respiratory Therapy
Atlantic Community College
Some College (No Degree) - Biology
Stockton State College
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