Gina Signore
Brownsburg,IN
Summary
Results-driven register nurse with 27 years of extensive experience in healthcare and clinical research across multiple therapeutic areas. Proven expertise in problem-solving, effective communication, and team leadership, leading to successful project outcomes and enhanced operational efficiency. Aiming to leverage this wealth of knowledge to drive innovation and excellence in a forward-thinking organization.
Overview
28
28
years of professional experience
Work History
Sr. Global Clinical Trial Manager
Syneos Health
01.2022 - Current
- Global trial manager responsible for the oversight and delivery of all clinical aspects of the trial
- Involved in resourcing, budgeting, regional CTM support, CRA support, site level support, protocol knowledge, vendor management
- Ensure TMF completeness
- Multidisciplinary collaboration, including regulatory, medical, vendors, site staff, PIs, and project managers.
- Achieved 'exemplary' annual performance rating
- Received multiple recognitions from colleagues of being a team player and excellent work
- Provided leadership and oversight for global clinical trial monitoring, ensuring quality deliverables at each stage.
Sr. Clinical Trial Manager
Clinipace
01.2021 - 01.2022
- Supervision of the preparation, conduct and reporting of site identification, selection, site initiation, routine monitoring and close-out visits
- Collecting and reporting on project status updates; preparation of investigator newsletters, monitoring project timelines and patient enrollment, management of KPI, monitoring and evaluation of team members performance, coordination of project team in designated countries
- Oversight of CRA's; planning, implementation, and management of projects in compliance within industry regulation
- Oversight of site start-up activities, IP readiness, escalation of resourcing issues, CRA training, supervision of TMF, ISF maintenance
Sr. Clinical Trial Lead
PSI-CRO
01.2019 - 01.2021
- Supervision of the preparation, conduct and reporting of site identification, selection, site initiation, routine monitoring and close-out visits
- Collecting and reporting on project status updates; preparation of investigator newsletters, monitoring project timelines and patient enrollment, management of KPI, monitoring and evaluation of team members performance, coordination of project team in designated countries
- Oversight of CRA's; planning, implementation, and management of projects in compliance within industry regulation
- Oversight of site start-up activities, IP readiness, escalation of resourcing issues, CRA training, supervision of TMF, ISF maintenance
Regional Site Manager
Boehringer Ingelheim
01.2013 - 01.2019
- Responsible for facilitating the clinical investigator selection process, managed patient enrollment and oversees the clinical trial operations at the study site from site selection to closeout
- Monitoring oncology, dermatology, cardiology, neurology
Regional Site Manager
Forest Research Institute
01.2011 - 01.2013
- Responsible for facilitating the clinical investigator selection process, managed patient enrollment and oversaw the clinical trial operation utilizing fundamental principles of monitoring at the study site from site selection to closeout
Clinical Research Associate
Abbott Laboratories
01.2010 - 01.2011
- Responsible for facilitating the clinical investigator selection process, managed patient enrollment and oversaw the clinical trial operation utilizing fundamental principles of monitoring at the study site from site selection to closeout
- Monitored antiviral HCV, pain, oncology, neuroscience
Sr. Clinical Research Associate
Eli Lilly and Company
01.2006 - 01.2010
- Responsible for facilitating the clinical investigator selection process, managed patient enrollment and oversaw the clinical trial operation utilizing fundamental principles of monitoring at the study site from site selection to closeout
- Monitored phase I-IV oncology and critical care
Health Care Professional
Eli Lilly and Company
01.2003 - 01.2006
- Provided scientific information to the general public and healthcare professionals about Lilly Oncology, critical care and neuroscience products
- Identified and reported adverse events. Served as a subject matter expert in identifying and documenting AE's, SAE's
- Served as a Product Complaint Champion, the go-to person for any product complaints
- Served as a Product Champion between Medical Information and The Lilly Answer Center team members
- Trained new-hires as well as provided continuing education for existing employees
Charge Nurse/Staff Nurse
01.1997 - 01.2003
- Served as a nurse caring for patients with hematology malignancies and solid tumors
- Have extensive pharmaceutical knowledge due to administering medications, patient teaching of drug actions and responding to adverse side effects
- Provided education and support to patients and families in coping with illnesses
- Contributed to unit by attending staff meetings, performing monthly QA monitor, joined hospital committees, continued education through reading journals and attending seminars
Education
Masters in Business Administration - Project Management -
American Intercontinental University
Hoffman Estates, IL07.2007
Bachelor of Science - Nursing -
Purdue University
West Lafayette, IN05.2001
Diploma in Nursing -
St. Elizabeth School of Nursing
Lafayette, IN05.1997
Skills
- Microsoft Word
- Microsoft Excel
- Microsoft Outlook
- Microsoft PowerPoint
- Inform
- Medidata IMPACT
- CTMS
- Oncology
- Hematology
- Oncology
- Dermatology
- Endocrinology
- Neurology
- Cardiology
- Pulmonology
- Immunology
- Site selection
- Investigator relations
- Customer focus
- Clinical trial oversight
- GCP training
- Adverse Event identification
- Adverse event reporting
- product complaints
- Study design
- Training and mentoring
- Clinical monitoring
- Results-oriented
- Audit preparation
- Adverse event reporting
- Patient recruitment
- Feasibility analysis
- Document review
- Pharmacovigilance
References
References available upon request.
Therapeuticexperience
- Oncology
- Hematology
- Dermatology
- Endocrinology
- Neurology
- Cardiology
- Pulmonology
- Immunology
Timeline
Sr. Global Clinical Trial Manager
Syneos Health
01.2022 - Current
Sr. Clinical Trial Manager
Clinipace
01.2021 - 01.2022
Sr. Clinical Trial Lead
PSI-CRO
01.2019 - 01.2021
Regional Site Manager
Boehringer Ingelheim
01.2013 - 01.2019
Regional Site Manager
Forest Research Institute
01.2011 - 01.2013
Clinical Research Associate
Abbott Laboratories
01.2010 - 01.2011
Sr. Clinical Research Associate
Eli Lilly and Company
01.2006 - 01.2010
Health Care Professional
Eli Lilly and Company
01.2003 - 01.2006
Charge Nurse/Staff Nurse
01.1997 - 01.2003
Masters in Business Administration - Project Management -
American Intercontinental University
Bachelor of Science - Nursing -
Purdue University
Diploma in Nursing -
St. Elizabeth School of Nursing
Similar Profiles
Jessica Alejandra Mateos RodríguezJessica Alejandra Mateos Rodríguez
Senior Clinical Research Associate at Syneos HealthSenior Clinical Research Associate at Syneos Health
Disha Nitin JoshiDisha Nitin Joshi
Analytical Scientist II at Syneos HealthAnalytical Scientist II at Syneos Health
Korissa PayneKorissa Payne
Engagement Center Medical Information Support Spec at Syneos HealthEngagement Center Medical Information Support Spec at Syneos Health
Jaime BirtJaime Birt
Associate Director Clinical Trial Management at Syneos HealthAssociate Director Clinical Trial Management at Syneos Health
John FileJohn File
Team Lead Formulation at Incog BiopharmaTeam Lead Formulation at Incog Biopharma