Judy Wolfinger
Riegelsville,USA
Summary
Seasoned professional with a robust background in clinical trial management and data analysis, notably at Johnson & Johnson. Excelled in enhancing TMF system efficiencies and ensuring compliance, leveraging expertise in Veeva TMF system and large dataset manipulation. Demonstrated exceptional multitasking abilities and a proactive approach to process improvement, significantly contributing to project success.
Overview
38
38
years of professional experience
1
1
Certification
Work History
Retired
Retired From Working
07.2024 - Current
Lead TMF COE Analyst
Janssen Research & Development
Titusville, NJ
06.2017 - 07.2024
- Identified opportunities for automation using artificial intelligence or machine learning.
- Identified opportunities for process improvement through leveraging emerging technologies such as artificial intelligence, machine learning.
- Assists in the development and monitoring of metrics as they pertain to the overall TMF quality review process that will allow for real-time data and visibility into the state of the TMF
- Responsible for providing oversight on management of Functional Area escalation framework and establishing relationship with assigned Functional Area Point of Contact (FA POC)
- Responsible for providing oversight and monitoring Functional Area TMF Completeness Quality Review and support FA users to develop inspection ready TMF
- Uses the V-TMF reporting tool to monitor TMF completeness by functional area and supports the user community in the use of the reporting tool
- Admin/Super User of the Veeva V-TMF system
- Partners with teams within EBIS (e.g.: CTMS, MDM) to align on Study/Country/Site build as well as general support
- Responsible for Study build maintenance, error resolution, reading system synchronization logs to identify failures
- Responsible for working with various teams to lead and support the management of TMF documents and maintaining inspection and submission readiness within the V- TMF system
- Works with the TMF COE management team and other team members to locate and identify areas yielding the highest efficiency, continued business improvement.
- Responsible for leading and supporting the user community in the management of TMF content as a Central Import and Classification service SME.
- Responsible for study lock/unlock in V-TMF
- Supports Audits/Inspections
- Works with users to identify and manage study expected document lists (EDL), define templates
- Provides system demonstrations to TMF Content Owners as needed
- Supports TMF Business Operations team in addressing business user questions and onboarding new functional areas, groups (e.g.: CRO, external partners, site staff) and departments
- Supports any other tasks that are relevant to TMF.
Local Trial Manager
Johnson & Johnson Pharmaceutical Research & Development, LLC
Titusville, NJ
06.2010 - 06.2017
- Responsible for clinical trial execution from study start up through final database lock ensuring that Clinical Development Team and organizational requirements are met
- Initiate investigator selection and recruitment, evaluate feasibility of site participation
- Collaborate with regional site management to ensure that clinical sites are conducting studies in compliance with Code of Federal Regulations and ICH Guidelines including GCPs and internal SOPs
- Ensure proper safety reporting, track and report study enrollment progress and problem solving decisions to management and team
- Actively participate in protocol review and Case Report Form (CRF) design
- Study budget preparation, contract negotiation, manage investigator budgets and payments
- Ensure accuracy of financial accruals in preparation for monthly and yearly close
- Liaison with CROs and other outside vendors and clinical supply management
- Assist with the organization of investigator meetings
- Review regional monitoring reports and identify field activities
- Communicate written and orally in a clear and effective manner with investigative sites, team members and functional management regarding the contractual and payment status of responsible sites
Senior Associate, Global Clinical Quality Assurance
Johnson & Johnson Pharmaceutical Research & Development, LLC
Raritan, NJ
01.2006 - 05.2010
- Assures compliance with regulatory requirements and internal JJPRD procedures by planning and conducting QA inspections, report audits, internal and external facility evaluations and validation and data reviews that support company development projects
- Prepare and issue reports of findings to identify issues and recommend actions as solutions to issues identified throughout the inspection/audit process
- Participate and assist in regulatory agency inspections, project team meetings, and training activities
- Drafts, revises, reviews and contributes to SOPs
- Suggests process improvements and contributions to the ongoing development of new auditing procedures, techniques and departmental guidelines
Project Manager
Ethicon, Inc.
Somerville, NJ
01.2005 - 12.2005
- Responsible for project team representation, initiation, monitoring, completion and reporting of clinical studies required on assigned projects
- Management of pre-approval and post-marketing clinical trials that support business objectives
- Facilitate the development of study protocols by coordinating input from various sources: literature, experts and internal team members
- Actively participate in protocol review and Case Report Form (CRF) design
- Implement trials including CRO selection, investigator identification, timeline management, investigator communication, monitoring and budget maintenance
- Study budget preparation, contract negotiation, manage investigator budgets and payments
- Study report, manuscript and publication plan management
- Participate on project teams and in business strategy development
- Oversee Investigator Initiated Studies
- Organize, coordinate and participate in Investigator meetings
- Ensure proper safety reporting as well as track and report study enrollment progress through CTMS
- Liaison with CROs and other outside vendors and clinical supply management
Local Trial Manager
Johnson & Johnson Pharmaceutical Research & Development, LLC
Titusville, NJ
04.2002 - 01.2005
- Responsible for clinical trial execution from study start up through final database lock ensuring that Clinical Development Team and organizational requirements are met
- Initiate investigator selection and recruitment, evaluate feasibility of site participation
- Collaborate with regional site management to ensure that clinical sites are conducting studies in compliance with Code of Federal Regulations and ICH Guidelines including GCPs and internal SOPs
- Ensure proper safety reporting, track and report study enrollment progress and problem solving decisions to management and team
- Actively participate in protocol review and Case Report Form (CRF) design
- Study budget preparation, contract negotiation, manage investigator budgets and payments
- Ensure accuracy of financial accruals in preparation for monthly and yearly close
- Liaison with CROs and other outside vendors and clinical supply management
- Assist with the organization of investigator meetings
- Review regional monitoring reports and identify field activities
- Communicate, written and orally, in a clear and effective manner with investigative sites, team members, and functional management regarding the contractual and payment status of responsible sites.
Senior Clinical Data Manager
Johnson & Johnson Pharmaceutical Research & Development, LLC
Titusville, NJ
01.2000 - 03.2002
- Responsible for data management of outsourced clinical trials
- Reviewed and approved data review plans, database structure, data entry guidelines, coding conventions and other data handling documentation
- Reviewed data transfers for accuracy, consistency and compliance with company standards
- Provided feedback to the CRO detailing discrepancies
- Reconcile the serious adverse event database to the clinical trial database to ensure consistency
- Coding of adverse events, concomitant medication and other trial specific data
- Review and resolve discrepancies on ancillary data received electronically for merging into the clinical trial database
- Interface with members of the global clinical trial team to meet established timelines and improve data quality
- Participate in investigator meetings
- Served on the task forces for new data diagnostic edit spec program and on the startup of electronic data capture trials
Clinical Data Manager
Romac International for Janssen Pharmaceutica
Titusville, NJ
01.1999 - 12.1999
- Reviewed protocol and database structures to ensure appropriate collection of data on CRFs for consistency across trials
- Prepared and maintained the data review plan which contained coding conventions, validation and edit specifications, data handling procedures as well as protocol deviations
- Coded adverse events, concomitant medication and other trial specific data
- Reviewed data transfers for accuracy, consistency and compliance with company standards
- Communicated feedback to the CRO concerning data transfers
- Reconciled the serious adverse event database to the clinical trial database to ensure accuracy
Clinical Data Manager
Romac International for Novartis
Summit, NJ
01.1998 - 12.1998
- Phase III studies in dermatology, immunology and transplant therapeutic areas
- Responsible for overall study management, creating and testing of validation programs, drafting CRFs, drafting CRF completion guidelines and specific data entry guidelines, conducting validation and planning meetings, trial status updates and other trial related tasks
- CRO management of transplant and dermatology studies
- Reviewed data transfers, timelines and study reports
- Issued queries
- Use of Clintrial 4
Clinical Data Coordinator
IRI Trials Management Center @ Johnson & Johnson Pharmaceuticals
Annandale, NJ
01.1996 - 01.1998
- Project lead for HIV, prostate cancer, vaginal yeast infection and surgical trials
- Reviewed case report forms for errors, missing data, protocol violations, adverse reactions, discrepancies and inconsistencies
- Generated DCFs and then updated the clinical database with the resolution
- Communicated data findings and discrepancies with the regional CRA, mutually deciding on a course of action
- Maintained record keeping through a clinical study tracking system denoting progress of each study and the location and status of all CRFs
- Validated the database
- Code adverse experiences and concomitant therapy for data entry
- Use of SAS and Oracle databases
Utilization Review Coordinator
Overlook Hospital
Summit, NJ
01.1995 - 12.1995
- Reviewed and evaluated patient information to determine appropriate level of care and services required.
- Conducted utilization review activities including concurrent reviews, retrospective reviews, and discharge planning.
- Assessed the appropriateness of length of stay for inpatient admissions.
- Analyzed medical records to ensure compliance with regulatory requirements.
- Collaborated with providers to obtain required clinical information, supporting prior authorization determinations and individual inquiries.
- Investigated denials from payers for lack of medical necessity or level of care issues.
Utilization Review Coordinator
Home Life Financial Assurance Corporation
Piscataway, NJ
01.1994 - 12.1994
- Conducted utilization review activities including concurrent reviews, retrospective reviews, and discharge planning.
- Assessed the appropriateness of length of stay for inpatient admissions.
- Maintained awareness of government regulations, health insurance changes and financing options.
- Managed appeals for denied services, providing additional information to support medical necessity.
- Performed pre-certification, concurrent, and retrospective reviews of inpatient and outpatient services.
Utilization Review Coordinator
NJPR
Parsippany, NJ
09.1989 - 12.1993
- Reviewed and evaluated patient information to determine appropriate level of care and services required.
- Conducted utilization review activities including concurrent reviews, retrospective reviews, and discharge planning.
- Assessed the appropriateness of length of stay for inpatient admissions.
- Analyzed medical records to ensure compliance with regulatory requirements.
- Communicated authorization decisions to providers and patients in a timely manner.
- Collaborated with providers to obtain required clinical information, supporting prior authorization determinations and individual inquiries.
- Referred cases to secondary review for failure to meet criteria.
Head Nurse/Charge Nurse
Hagadorn Center for Geriatrics
Glen Gardner, NJ
01.1988 - 12.1989
- Collaborated with physicians, psychiatrists, social workers and other healthcare professionals to ensure quality care for patients.
- Prescribed medications in accordance with physician orders, monitored side effects, and adjusted dosages as needed.
- Provided direct patient care by assessing and monitoring physical, psychological and emotional status of patients.
- Participated in multidisciplinary team meetings to discuss patient cases and develop comprehensive treatment plans.
- Performed ongoing assessments of client's needs throughout the course of their treatment program.
- Responded promptly to emergency situations involving behavioral disturbances or potential harm to self or others.
Staff Nurse
Hunterdon Medical Center
Flemington, NJ
01.1988 - 12.1988
- Maintained accurate records of patient progress notes, medications administered and other relevant data.
- Demonstrated effective communication skills while interacting with patients, families, physicians and other healthcare staff members.
- Actively participated in departmental meetings, training sessions and educational seminars.
- Managed multiple tasks simultaneously while maintaining quality standards of care.
- Assessed patients to determine their physical condition, health status and needs.
- Provided direct patient care including wound dressing, administering medication and IV therapy.
- Monitored vital signs and documented changes in a timely manner.
- Advocated for patient needs with interdisciplinary team and implemented outlined treatment plans.
HIV Staff Nurse
Orlando Regional Medical Center
Orlando, FL
07.1986 - 12.1987
- Maintained accurate records of patient progress notes, medications administered and other relevant data.
- Developed individualized teaching strategies for each patient based on their specific needs.
- Assisted physicians with exams, lab tests or other procedures as requested.
- Provided emotional support to family members during difficult times or end-of-life situations.
- Actively participated in departmental meetings, training sessions and educational seminars.
- Administered oral, IV and intra-muscular medications and monitored patient reactions.
Education
BSN - Nursing
Widener University
Chester, PennsylvaniaCertificate in Paralegal Studies -
National Academy For Paralegal Studies
Mahwah, N.J.Massage Therapist -
Brookdale community college
Skills
- Presentation building
- Template creation
- MS Excel
- Large dataset manipulation
- Trend forecasting
- Process enhancement
- Veeva TMF sysem
- Study Build
- Workflow Analysis
- Compliance Monitoring
- Multitasking Abilities
- Decision-Making
- Interpersonal Communication
Therapeuticexperience
- HIV/Anti-infectives Phase I-III
- Oncology Phase I-III
- Cell Therapy Phase I-IIb
- CNS: Phase III Bipolar and Pediatric Bipolar
- Phase I and III Schizophrenia
- Medical Devices: IDE, 510K and PMA Submission for Gynecology and Wound Management
Certification
- NURSING LICENSURE: NJ- 26NO08852700
- Certificate in Paralegal Studies National Academy For Paralegal Studies
- Massage Therapist Brookdale Community College
References
References available upon request.
Timeline
Retired
Retired From Working
07.2024 - Current
Lead TMF COE Analyst
Janssen Research & Development
06.2017 - 07.2024
Local Trial Manager
Johnson & Johnson Pharmaceutical Research & Development, LLC
06.2010 - 06.2017
Senior Associate, Global Clinical Quality Assurance
Johnson & Johnson Pharmaceutical Research & Development, LLC
01.2006 - 05.2010
Project Manager
Ethicon, Inc.
01.2005 - 12.2005
Local Trial Manager
Johnson & Johnson Pharmaceutical Research & Development, LLC
04.2002 - 01.2005
Senior Clinical Data Manager
Johnson & Johnson Pharmaceutical Research & Development, LLC
01.2000 - 03.2002
Clinical Data Manager
Romac International for Janssen Pharmaceutica
01.1999 - 12.1999
Clinical Data Manager
Romac International for Novartis
01.1998 - 12.1998
Clinical Data Coordinator
IRI Trials Management Center @ Johnson & Johnson Pharmaceuticals
01.1996 - 01.1998
Utilization Review Coordinator
Overlook Hospital
01.1995 - 12.1995
Utilization Review Coordinator
Home Life Financial Assurance Corporation
01.1994 - 12.1994
Utilization Review Coordinator
NJPR
09.1989 - 12.1993
Head Nurse/Charge Nurse
Hagadorn Center for Geriatrics
01.1988 - 12.1989
Staff Nurse
Hunterdon Medical Center
01.1988 - 12.1988
HIV Staff Nurse
Orlando Regional Medical Center
07.1986 - 12.1987
BSN - Nursing
Widener University
Certificate in Paralegal Studies -
National Academy For Paralegal Studies
Massage Therapist -
Brookdale community college
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