Janet LaBarbera
Mulberry
Summary
Dynamic Associate Director with over 10 years of experience in clinical operations and compliance, complemented by 25 years in clinical trial and systems management. Proven expertise in TMF record management (CDSIC TMF Standard and ALCOA+ standards), training, supervising, and mentoring team members. Skilled in managing clinical trial documentation, ensuring adherence to ICH-GCP guidelines, and leading cross-functional teams to successful project outcomes. Consistently improved inspection readiness and data accuracy. Proficient in communication, logistics, workforce management, and fostering collaboration to enhance document accessibility and quality. Proficient in communication, logistics, and workforce management. Skilled in cross-functional collaboration, compliance with ICH-GCP Guidelines, and enhancing document accessibility and quality. Eager to leverage expertise in clinical systems, records management, and regulatory compliance to contribute effectively.
Overview
26
26
years of professional experience
1
1
Certification
Work History
Associate Director, Document and Clinical Systems Management
Xeris Pharmaceuticals, Inc.
12.2022 - 08.2025
- Spearheaded the operational ownership of clinical systems such as eTMF and CTMS, ensuring compliance with ICH-GCP Guidelines and Controlled Documents (CDs), improving document accessibility and quality.
- Led the implementation and management of Veeva Vault TMF, ensuring compliance with CDSIC Trial Master File Reference Model and ALCOA+ standard, resulting in improved inspection readiness and document quality.
- Led cross-functional teams to successfully manage clinical trials, ensuring adherence to timelines and budgets as related to records management systems and resources.
- Utilized IRT systems for obtaining reports, reviewing, and reconciliation, enhancing data accuracy and efficiency throughout lifecycle of the study.
- Have general user understanding of ePRO (electronic Patient-Reported Outcome) and eCOA (electronic Clinical Outcome Assessment) systems.
- Led cross-functional collaboration and governance of clinical records across departments, maintaining TMF completeness, accessibility, quality, and compliance, resulting improvement in inspection readiness.
- Served as SME for internal and external inspections or audits as related to clinical study documentation and compliance related matters.
Associate Director Clinical Compliance, TMF Operations
Pfizer Pharmaceuticals (formerly Arena Pharmaceuticals)
San Diego
01.2022 - 11.2022
- Led the planning, execution, and completion of regional/global clinical trials, ensuring alignment with study timelines, budgets, SOPs, GCP, and regulatory guidelines.
- Identified and managed resource and system needs.
- Key leader in driving a cross-functional clinical trial team, partnering and collaborating with internal and external team members to execute trials.
- Improved document accessibility and quality by through strategic management and compliance with ICH-GCP Guidelines and Controlled Documents (CDs).
Head Trial Master File Operations, Senior Manager Clinical Compliance
Arena Pharmaceuticals
04.2021 - 01.2022
- Led the development and execution of clinical compliance strategy, ensuring alignment with ICH/GCP and regulatory requirements, resulting in improved inspection readiness.
- Implemented and maintained processes, SOPs, and systems within Clinical Operations, enhancing document accessibility and quality.
- Built and developed a high-performing team through effective people management and training, leading TMF resource planning activities and providing input to departmental budgets.
- Developed training programs to enhance staff skills and improve operational efficiency.
- Managed departmental budgets, ensuring resource allocation aligned with business goals.
- Coordinated with internal departments to ensure successful execution of projects according to timeline and budget constraints.
- Reviewed and updated documentation for accuracy and relevance in subject matter areas.
- Maintained updated knowledge through continuing education and advanced training.
- Served as SME for internal and external audits and regulatory inspections to ensure compliance.
Content Lead Manager
Chaucer
02.2019 - 09.2021
- Led the eTMF migration and implementation, ensuring compliance with regulatory standards and improving inspection readiness.
- Acted as Sr Project Associate (TMF SME), providing expertise in clinical operations regulatory documentation consolidation.
- Collaborated cross-functionally to streamline processes, enhancing document accessibility and quality.
Senior Manager – Projects – Life Sciences
Cognizant Technology Solutions
09.2019 - 04.2021
- Identified resources and maintained project timelines, ensuring compliance with GxP risk assessments and guidance documentation, enhancing project efficiency.
- Acted as GCP SME for post-acquisition assessments (PAA), TMF SME for eTMF implementation, and system migrations, improving inspection readiness.
- Led cross-functional teams in developing and maintaining implementation plans, ensuring seamless system migrations and compliance with regulatory standards.
Senior Associate Trial Master File
Pfizer
09.2016 - 02.2019
- Ensured TMF quality support for clinical trial documentation, improving compliance with TMF specifications and SOPs, enhancing inspection readiness.
- Maintained submission/inspection readiness criteria, ensuring high-quality documentation and adherence to regulatory requirements.
- Supported clinical trial documentation processes, contributing to overall trial success and compliance with applicable SOPs.
TMF Quality and Compliance Manager
Hospira
08.2014 - 12.2017
- Led internal audits and agency-level inspections, ensuring compliance with TMF regulations and improving inspection readiness.
- Developed and presented metrics for team and senior management, enhancing data accuracy and efficiency.
- Oversaw document management team, allocating resources effectively and maintaining project status read-outs for senior management.
Project Coordinator, Clinical Supplies (Randstad Pharma)
ASTELLAS
04.2014 - 06.2014
- Generated study level reconciliation reports and supported PAI and submission readiness at the program level, ensuring compliance with regulatory standards.
- Facilitated communication with IP vendors and depots for risk-based review, enhancing collaboration and efficiency.
- Improved inspection readiness by ##% through effective management and coordination of clinical systems and processes.
Global Project Coordinator
(AMN Healthcare) Covance
Madison
09.2013 - 04.2014
- Contributed to the implementation and migration of documentation in the eTMF, ensuring compliance with CRO and sponsor SOPs/processes, improving inspection readiness.
- Conducted TMF reviews throughout the study, enhancing document quality and accessibility, resulting in improvement in data accuracy.
- Generated compliance metrics for individual and program-level reviews, including ICH, GxP, and Regulatory, increasing regulatory compliance.
TMF Project Manager
OPKO Health (formerly Cytochroma)
09.2012 - 09.2013
- Led vendor identification and contract negotiations, enhancing vendor relationships and ensuring compliance with regulatory standards.
- Oversaw study conduct, startup activities, and site management, improving audit readiness and achieving improvement in inspection readiness.
- Directed personnel management, remote and on-site monitoring, and stakeholder meetings, ensuring effective resource allocation and milestone management.
Clinical Study Start-up Associate
Abbott
01.2000 - 09.2012
- Led study start-up, conduct, and close-out processes for Phase I, II, III, and PMOS studies across Oncology, Neurology, Immunology, and Rare Diseases, ensuring compliance with regulatory standards.
- Served as SME for document submission processes to FDA and local/global regulatory bodies, maintaining TMF in an inspection-ready state at all times.
- Achieved an accuracy rating of 98% across multiple programs for 5+ years, enhancing data quality and inspection readiness.
Education
Career Diploma - Pharmacy Technician
Penn Foster
Bachelor's Degree - Business Management
Open University
Skills
- TMF Manager
- IAOCR Accreditation
- ETMF systems
- CTMS systems
- Veeva platform
- Microsoft platform
- Process and training development
- Project Management
- Trial Management
- Clinical Documentation Systems
Certification
- TMF Manager, IAOCR, 12/01/21
- Certified Clinical Research Professional (CCRP), 10/01/10
Military Service
United States Air Force, 1985-1990, USAF Personnel and Supply Administrative duties primarily involve managing personnel records, processing promotions, assignments, and separations, as well as overseeing supply chain logistics.
Timeline
Associate Director, Document and Clinical Systems Management
Xeris Pharmaceuticals, Inc.
12.2022 - 08.2025
Associate Director Clinical Compliance, TMF Operations
Pfizer Pharmaceuticals (formerly Arena Pharmaceuticals)
01.2022 - 11.2022
Head Trial Master File Operations, Senior Manager Clinical Compliance
Arena Pharmaceuticals
04.2021 - 01.2022
Senior Manager – Projects – Life Sciences
Cognizant Technology Solutions
09.2019 - 04.2021
Content Lead Manager
Chaucer
02.2019 - 09.2021
Senior Associate Trial Master File
Pfizer
09.2016 - 02.2019
TMF Quality and Compliance Manager
Hospira
08.2014 - 12.2017
Project Coordinator, Clinical Supplies (Randstad Pharma)
ASTELLAS
04.2014 - 06.2014
Global Project Coordinator
(AMN Healthcare) Covance
09.2013 - 04.2014
TMF Project Manager
OPKO Health (formerly Cytochroma)
09.2012 - 09.2013
Clinical Study Start-up Associate
Abbott
01.2000 - 09.2012
Career Diploma - Pharmacy Technician
Penn Foster
Bachelor's Degree - Business Management
Open University