HEATHER LABARBARA
East Windsor,NJ
Summary
Senior Clinical Trial Specialist with 25+ years of pharmaceutical clinical trials experience with all therapeutic areas and all global phases of trials driving the operational execution of clinical studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/WPs. Experienced with all therapeutic areas and all global Phases of studies in-house as well as CRO studies. Leader and subject matter expert with various systems, while driving global trial excellence (therapeutic areas, high priority, all lifecycles) through cross-functional collaboration, process optimization, and compliance, with proven expertise in project management and stakeholder engagement all throughout a study's lifecycle.
Overview
23
23
years of professional experience
Work History
SENIOR GLOBAL TRIAL SPECIALIST, GLOBAL TRIAL MANAGEMENT
Bristol Myers Squibb
07.2020 - 12.2025
- Knowledge of various systems including, CTMS, TMF, SIP, and CARA/PRISM.
- Actively collaborated with team to achieve key milestone dates on time, if not sooner.
- Super User/Subject Matter Expert (SME)/Regional Trainer
- Participates on one or more cross-functional study team(s) and/or performance and quality oversight of one or more
- Ensuring TMF health was at 95-100% compliance at all times with accuracy and completion, collecting and developing study level documentation
- Manage the execution and setup of Data Monitoring Committees and Study Steering Committees.
- Responsible for Investigator Meeting planning and execution.
- Manage country level planning, protocol level attributes and milestones/drivers in CTMS ensuring data quality health was always good.
- Develop, update and submit Transfer of Obligations to Regulatory Authorities.
- Manage the global vendor site lists and resolve issues related to site lists.
- Manage study level mail-groups/distributions and SharePoint/Study Directory access and updates.
- Actively participate in study team meetings for assigned protocols while taking meeting minutes.
- Drive process/system enhancements related to role responsibilities/deliverables.
- Identify issues and risks, develop mitigations and escalate appropriately.
SENIOR PROTOCOL SPECIALIST, GLOBAL TRIAL MANAGEMENT
Bristol Myers Squibb
07.2017 - 07.2020
- Manage collection and development of study level documentation, ensuring eTMF accuracy and completion for all studies.
- Super User/Subject Matter Expert (SME)/Regional Trainer for new Protocol Specialist hires for Eclipse system.
- Hold Eclipse Round Table discussions with team to address any updates to the system.
- Manage the execution and setup of Data Monitoring Committees and Study Steering Committees.
- Responsible for Investigator Meeting planning and execution.
- Manage country level planning, protocol level attributes and milestones/drivers in Eclipse.
- Manage study level documentation and set up within My Trials/SIP.
- Develop, update and submit Transfer of Obligations to Regulatory Authorities.
- Manage the global vendor site lists and resolve issues related to site lists.
- Manage the global setup of study level non-clinical supplies.
- Manage study level mail-groups/distributions and SharePoint/Study Directory access and updates.
- Actively participate in study team meetings for assigned protocols.
- Identify issues and risks, develop mitigations and escalate appropriately.
- Manage and comply with various quality and compliance systems.
- Participate in filing activities as applicable.
- Communicate with external collaborators and drive creation of protocol number creation.
- Driving Milestones and Drivers, site creation for external collaborators.
- Manage initial lab site kit requests for ECOG.
- Manage Data Quality metrics reports to ensure metrics stay at a high percentage for data quality.
- Drive quality checks in Eclipse for CRO studies to ensure milestones and drivers are being entered.
SENIOR CLINICAL TRIAL ASSOCIATE
Bristol Myers Squibb
05.2012 - 07.2017
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Create and ship regulatory binders for site staff
- Followed informed consent processes and maintained records.
- Collect, enter, and track study data from 1572's or reports from various systems.
- Assisted Site Managers and Protocol Managers with enrollment, maintenance, or closure activities.
SENIOR CLINICAL TRIALS ASSOCIATE
Bristol Myers Squibb
04.2008 - 07.2017
- Work closely with IRIS/Regulatory on requests to update data in Eclipse to reflect their data in IRIS.
- Collect, enter, and track study data from 1572’s or reports within Eclipse system.
- Multitasks/able to work on many projects/multiple therapeutic areas at the same time from startup to completion.
- Work on both BMS in house studies as well as CRO studies.
- Holds CTMS/Eclipse Super User meetings and communicates updates accordingly to BMS and CRO personnel.
- Assisted with the SMART initiative.
- Run reports in Eclipse and IRIS for reconciliation of studies and tasks.
- Provide assistance to Site Managers, Protocol Managers, or Project CTA’s when help is needed.
SPECIALIZED SERVICES CLINICAL TRIAL ASSOCIATE
Bristol Myers Squibb
05.2008 - 08.2016
- Responsible for regulatory documents to be uploaded accurately in system for audits.
- Enter key milestone dates in IMPACT
- Collect, enter, and track study data from 1572's or reports from systems.
- Reconcile studies at closure.
ADMINISTRATIVE ASSOCIATE
Bristol Myers Squibb
09.2002 - 05.2008
- Drafted professional memos, letters, and marketing copy to support business objectives and growth.
- Answered multi-line phone system, routing calls, delivering messages to staff and greeting visitors.
- Edited documents to improve accuracy of language, flow, and readability.
- Updated spreadsheets and databases to track, analyze, and report on performance and sales data.
- Scheduled flight arrangements
- Created Powerpoint presentations for key stakeholders.
Education
Bachelors (BA) - General Studies
American Public University Online
12-2011
Associate in Science Degree (A.S.) - Office Management
Middlesex Country College
Woodbridge, NJ01.2000
Skills
- Communication
- Problem Solving
- Leading Initiatives
- Critical Thinking
- Process Improvements
- Collaboration
- Organization
- Attention to detail
- CTMS Super User Subject Matter Expert (SME)
- Training Onboarding new hires
- Strong knowledge of CTMS TMF SIP CARA/PRISM
- Team Player
- Audits
Websites
Timeline
SENIOR GLOBAL TRIAL SPECIALIST, GLOBAL TRIAL MANAGEMENT
Bristol Myers Squibb
07.2020 - 12.2025
SENIOR PROTOCOL SPECIALIST, GLOBAL TRIAL MANAGEMENT
Bristol Myers Squibb
07.2017 - 07.2020
SENIOR CLINICAL TRIAL ASSOCIATE
Bristol Myers Squibb
05.2012 - 07.2017
SPECIALIZED SERVICES CLINICAL TRIAL ASSOCIATE
Bristol Myers Squibb
05.2008 - 08.2016
SENIOR CLINICAL TRIALS ASSOCIATE
Bristol Myers Squibb
04.2008 - 07.2017
ADMINISTRATIVE ASSOCIATE
Bristol Myers Squibb
09.2002 - 05.2008
Bachelors (BA) - General Studies
American Public University Online
Associate in Science Degree (A.S.) - Office Management
Middlesex Country College