Summary
Overview
Work History
Education
Skills
Accomplishments
Certification
 Certificate of Recognition from J&J’s WORKSENSE Program, for going above and beyond in providing s
Languages
Timeline
AdministrativeAssistant
Judith Vekony

Judith Vekony

Project Manager
Flemington,NJ

Summary

Accomplished Clinical Project Manager with a global mindset and over 14 years of expertise in the Pharmaceutical Industry, Biotechnology, R&D Procurement, Compliance, Business Operations, end-to-end Contract Management, Clinical Trial Operations, and processes (Phases I-IV), as well as clinical vendor qualification, oversight, and supplier diversity.

Skilled at leading complex, cross-functional projects, driving strategic initiatives, and delivering innovative business solutions.

Strong analytical and problem-solving abilities, with expertise in stakeholder management, risk mitigation, and process optimization.

Experienced in clinical vendor selection, qualification, vendor management, and third-party risk assessment, ensuring regulatory compliance and operational excellence.

Proficient in financial oversight, budget management, and contract negotiation, delivering cost-effective solutions.

Effective communicator and collaborator, adept at building relationships, influencing decisions, and aligning teams toward shared objectives.

Possesses extensive organizational, analytical, and problem-solving skills, excelling in fast-paced environments with competing priorities and tight deadlines.

Passionate about continuous improvement, innovation, and mission-driven work aligned with organizational values.

Overview

14
14
years of professional experience
1
1
Certification

Work History

Project Manager - PM / Operational Excellence Team

Daiichi Sankyo
09.2023 - 02.2025
  • Lead IT Implementation & US Finance/P2P
  • Contract through Net2Source, 2025
  • Led the successful implementation of Smartsheet as a strategic IT solution within the GDX-DI-CoE – Data & Statistical Sciences Center (DSS) / Global CR2 department
  • Collaborated with the Head of PMOE, US Leadership Team, and Global DX Team to ensure seamless integration of key business capabilities
  • Financial Tracker: Led project management for departmental financial tracking
  • NPI/SAI Initiatives: Spearheaded Smartsheet implementation, process enhancements, operational improvements, and data collection template creation; provided training for project leads and NPI owners
  • Project Planning Tracker: Served as core team member and SME for portfolio-level study planning and tracking
  • Facilitated and managed compound review meetings with Leadership and compound leads, driving additional technical solution implementations, integrating operational excellence, continuous improvement, and best practices across projects
  • Provided essential support and training to Leadership and management members on the newly rolled-out business solution
  • Led Operational Excellence initiatives, overseeing end-to-end all US Procurement-to-Pay Processes, Contract execution, purchase order management, change management, Cost savings, and vendor negotiations while ensuring compliance, efficiency, and streamlined communication across Legal, Finance, IT, Procurement, stakeholders, suppliers and vendors
  • Additionally managed all contracts and POs for the Head of Data Governance
  • Led Vendor Relationship Management, including vendor selection processing, vendor oversight, stakeholder management, and facilitation of new vendor onboarding
  • Monitored project timelines and scope deliverables, identified risks, mitigated issues, tracked milestones and metrics, and resolved conflicts in a proactive and timely manner
  • Delivered weekly review of US Expenses to Sr LT member and provided root cause analysis of unfunded POs, reconciled multiple Invoice mismatches, and identified, mitigated, and resolved risks regarding Project timelines, system access, and migration-related issues, while optimizing and leveraging source data and information
  • Managed all monthly US expenses and SAP-based financial data for the Global CR2 department, including actuals for all financial categories
  • Supported the facilitation of Budget planning, Latest Estimates, Overhead, Internal Order, and Headcount forecasting planning and management in the newly developed Smartsheet system, tracking project budgets efficiently and effectively
  • Ensured that all categories, WBS, cost centers, and invoicing were properly aligned and monitored all discrepancies and issues
  • Achieved continuous improvement and innovation within processes and systems, creating a PMOE team’s Weekly Dashboard Meeting Tracker and Issues & Action Tracker in Smartsheet team to ensure the timely delivery of the NPI/SAI project
  • Developed a Process mapping, Compound review meeting management solution in Smartsheet, as well as a Contract, Vendor, and PO tracker for all PM, Operational Excellence, Procurement, Contracting, Outsourcing, Vendor Management, P2P, financial tracking, and technical solution-relevant tasks, fostering successful and effective collaborations and relationships
  • Managed non-study related e2e project tracking and lifecycle, from data collection process implementation to ensuring timelines are met, and goals are achieved efficiently
  • Managed departmental user access and cross-functional group memberships in Smartsheet, working closely with the IT director to manage risks, issues, escalations, technical support, and vendor KPIs
  • Additional Financial, Contract to PO, Invoice mismatch reconciliation and Vendor Management support provided cross-functionally to the Head of Data Governance, while overseeing the financial aspects and vendor interactions within the US CR2 department, ensuring effective budget management and successful collaborations
  • Operations Excellence: Collaborated with the head of project management and operations excellence to ensure the team's smooth operations, including meeting management, tracking development plans and timelines, managing scope, and mitigating risks
  • Organized, facilitated and participated in internal, LT, cross regional and cross functional stakeholder-aligned meetings, project KOM, Review Committee Meetings for all ongoing and new NPI /SAI with LT
  • Finance Forecasting and Resource Planning: Managed finance forecasts, actuals, and optimized resource planning to achieve project objectives effectively
  • Proactively identified challenges and implemented effective solutions to maintain project momentum and achieve desired outcomes
  • Stakeholder Collaboration with key stakeholders such as finance, procurement, IT, legal, compliance, and QA to ensure smooth project execution.
  • Developed comprehensive project plans with clear timelines, milestones, and budget requirements, ensuring timely delivery of high-quality results.
  • Negotiated contracts with suppliers to secure better terms, resulting in cost savings.

Project Manager- Vendor Management

Boehringer Ingelheim, SpectraForce Inc
01.2023 - 09.2023
  • Responsible for coordinating project activities and resources in support of new, moderate and highly complex vendor assessment and engagement projects for Clinical Development & Operations
  • Led new vendor identification and due diligence assessment in conjunction with cross-functional partner alignment and enabling functions e.g
  • Sourcing, Quality, Compliance, Clinical Development and clinical study conduct teams, Clinical Trial leads etc
  • Liaised with Global Vendor Management, Global Sourcing regarding implementation of local vendor engagement for FSP, Full Service CRO, Ancillary Clinical Supplier Services, e.g
  • Central & Specialty Labs
  • Managed issue escalation, remediation and resolution of assigned projects, driving on time, quality delivery of services within budget
  • Facilitated vendor capability meetings, presentations, and Governance Meetings
  • Coordinated RFx, RFI/RFP (Request For Information & Proposal) events in conjunction with client sourcing
  • Led the development and oversight of all project plans and timelines with new vendors requiring stakeholder approval and funding
  • Actively engaged with preferred and strategic (Pilot phase) vendors' senior leadership and BI clinical trial leadership team members to build strong relationships, ensuring compliance and quality-aligned key performance and metrics to meet specific contracting and trial milestones
  • Coordinated and facilitated the scope of work development process in conjunction with cross-functional stakeholders, while liaised with Global Sourcing to ensure the scope of work, project delivery schedule, and key deliverables were properly outlined in contractual agreements and ensured MSAs were structured to reflect vendor’s performance indicators, CD&O’s business requirements for new engagements
  • Managed projects, project scheduling, allocation and management of resources, risk management, project finances, partner/contract management and timely execution, progress tracking, KPIs, monitoring change control process, Operations Manual creation and Timeline documentation, training, defining and translating work/tasks into actionable plans and on-time project delivery
  • Assessed and developed new & existing processes and identified ways to improve Operation Manuals, Issue tracking, management, communication and escalations, project communication, and cross-functional interactions
  • Project-managed a major reorganization of the Vendor Management Team and change management relevant to the migration of the Vendor Management process, creating a Transitional Vendor Management Report and processes documentation, and securing end-to-end knowledge transfer
  • Managed and supported of all Vendor Management’s Reporting to senior leadership within BI & collaboratively with vendors
  • Monthly 2023 PO Workbook with Pivots, SAP, Invoice management
  • To Finance Director
  • Site Monitoring hours/ YTD Monthly Operations Report with Macros – to Finance Director
  • CRA Trip Report
  • CRA Calendars
  • Major CRO Transition Reports
  • TimeRecorder Weekly & monthly Reports for all Vendors and Clinical Resources
  • LOS Compliance & Training reminder reports generation for all Vendor / Resources
  • Vendor Tenure Reports
  • Journix Report
  • TransPerfect Report
  • Managed clinical vendors' onboarding and offboarding, and timekeeping through Time Recorder
  • Managed the Vendor Management Inbox and Master List for all Clinical resources
  • Managed and supported Change Order /Purchase Requisition and Purchase Order processes and Invoice review and mismatch reconciliations
  • Provided Training to the newly onboarded Associate Director of Vendor management on processes

Vendor Manager III

TD Bank
07.2022 - 01.2023
  • Through Global Technical Talent, GTT LLC
  • USTS Platform & Technology Vendor Management Office Ctr of Excellence-TPRM, Independently project managed all stages of the TPLM for all Global Delivery Third Party Business Engagements for TD Bank AMCB USTS Platform and Technology while aligning with the organizations framework policies and standards
  • Identified and resolved complex global delivery-related engagements, leading collaborative efforts amongst management, vendor contacts, and stakeholders to resolve any escalated TPRM issue in a timely manner and compliantly
  • Managed, monitored, analyzed, and reported business engagement performance, identifying and escalating issues requiring mitigation
  • Provided critical and strategic insights, value-added input, and training to team members and cross-functional stakeholders, various business segments as an Ariba-related super user and SME with extensive skillset, and knowledge, while supporting the business regarding new PR/PO process rollout and change management-related principles and executing several legacy and contract compliance related PR submissions and PO processes
  • Led and guided others within area of expertise regarding the end-to-end business approval process management for all global delivery contracts, purchase requisition- purchase order lifecycle, vendor alliance, TPRM & relationship management with tech vendors such as Cognizant, TCS, Wipro in close alliance and collaboration with Line of Business, Strategic Sourcing Managers, S&P managers, and all stakeholders that provide funding, and approvals
  • Managed cross-functional collaboration with line of business, Lead Vendor Managers, Portfolio leads, VMO TPRM, strategic sourcing group, finance, legal, vendors, and other business segments in all areas of Vendor Management, etc
  • While providing best practices, process improvements, efficiency ideas to AVP, VP of US Tech Solution Platform & Technology – Vendor Management office CoE and created aligned business tools for more efficient and effective execution
  • Executed Privacy Impact Assessment, Risk management, IRA (Inherent Risk Assessment) & TPSD (Third Party Service Delivery management)
  • Provided support to multiple Vendor Managers with pricing and terms
  • Participated in vendor relationship management, conducting weekly alignments with vendors to address contract management, operational issues, and issue escalation, as well as key performance management and related matters, and supported IT system analysts
  • Supported all legacy and new contract compliance owner responsibilities, approvals, Purchase Requisition creation, PO submissions
  • Impacted the achievement of sub-function or business line objectives within VMO, while supporting advanced methods, and contributed to new solutions, such as utilization of Power BI
  • Communicated difficult concepts cross-functionally, within the line of business, as the VM lead and converted compelling business context to influence and gain alignment across increasingly senior stakeholders

Gilead Sciences / Senior Manager, Vendor Qualification Lead

UniconPharma Inc
01.2021 - 07.2021
  • Vendor Outsourcing and Operations – Development Business Operation Dec, 2022
  • Managed the e2e Vendor Qualifications (VQ) and requalification of new and onboarded vendors with new capabilities, in the clinical outsourcing of global Phase I-IV clinical trials, including clinical monitoring, data management, biostatistics, medical writing, Phase 1 CRU, central, biomarker, bioanalytical lab, RTSM, eCOA, medical imaging, safety, e-informed consent, mobile HCP services, telemedicine and wearables/sensors, reporting to the Sr. Director
  • Vendor Outsourcing & Operations
  • Conducted e2e vendor assessments supporting IT Security & Privacy Assessments, Anti-Bribery, and Anti-Corruption Due Diligence, and created training, reference documents and RACI charts for both processes, while executing Change Management related mapping and migration of the IT Tracker to the VQ Tracker and leading several Inspection Readiness related team projects
  • Participated in the creation, development, and continuous process improvement of the VQ Process Flows, and e2e VQ processes, development of the Vendor Qualification Tracker, Dun & Bradstreet, ABAC processes, aligned with training, and onboarding support for additional VQ team leads
  • Led and managed the life cycle of vendor qualification processes, including assembling and leading cross-functional vendor qualification teams, managing tracking and triaging of all VQ requests, risk assessment of high, medium & low-risk criteria vendors, scheduling, maintaining an approved vendor services list, VQ Tracker, libraries of standards, VQ Corporate and Technical Questionnaires, Qualified Vendor List and Report
  • Managed notification of vendors, setting agendas, conducting vendor qualifications-related evaluations, VQ intake and triaging, creating and executing vendor qualification reports, and other routine report outs for senior management
  • Utilized Power BI and Tableau to provide data visualization, data analytics and business intelligence
  • Coordinated the assembly and launched effective cross-functional team collaborations and VQ team meetings with Vendor Outsourcing Leadership and Contract Managers, DBO colleagues, Vendor Qualification Teams, and other Vendor Selection Team members, internal and external stakeholders, regarding the e2e vendor qualification process
  • Led various project management tasks and interacted with internal and external teams, such as, R&D Quality & Compliance, Clinical Operations, Finance, Legal, Business Conduct, Vendor Relationship Management, Payments, Continuous Improvement and vendor contacts, while aligning with thorough knowledge of Good Clinical Practice “GCP”, Good Pharmacovigilance Practices “GVP”, Good Laboratory Practice “GLP”, Good Documentation Practice “GDP” and ICH E6 R2 compliance requirements, and current global and regional trends in compliance.

Vendor Oversight Process Manager

Bristol Myers Squibb
12.2010 - 01.2021
  • Global Development Operations – Clinical Trial Business Partnerships, Planning & Alliance Mgt
  • Managed all global vendor oversight processes, within BMS’s Global Development Operations functionalities for the organization’s Clinical Data Provider Partnerships (Axillary services) and Clinical Trial Business Partnership with major CROs and GVOO vendor enablement, while provided guidance and support activities within Global Development Operations [GDO] to team members for all vendor oversight processes according to ICH E6 (R2) standards
  • Achieved 100% metrics for three Vendor Oversight (VO) Plan implementation related uplifts, reference to Vendor Trial Oversight Templates completion, Veeva Vault based Controlled Document Repository (CDRep) uploads and Global Vendor Oversight & Operations SharePoint based VO Program related document and eTrial Master Filing (eTMF)
  • Managed reporting via Tableau & Power BI
  • Collaborated in the migration of Clinical Research Operating Model Evolution (CROME) initiatives for Clinical Trials
  • Coordinated, and drove Vendor Oversight migration for 5 Myokardia & DragonFly, Celgene in-flight studies, ensuring proper alignment with BMS’s Clinical Trial Business Partnership, change management, and new CRO Operating model alignment
  • Provided CDRep – Controlled Document Repository, SME, super user support, and training with GVOO head and department lead
  • Provided Monthly GVOO Metrics Reporting by utilization of three Eclipse, Celtrak, and eTMF reports for GVOO leadership on Vendor Trial Oversight Template completion and compliance per PFPV requirements, while providing support to GTMs, OPLs and Outsourcing Management team members to ensure compliance
  • Created and maintained business capability and continuous improvement aligned tools and trackers (e.g., Project Tracker, Approved Vendor List, GVOO Team Meeting Agenda framework, multi-leadership and project-related meetings via OneNote and trained team members in system functionalities
  • Utilized and provided soft launch-related system user feedback for the newly launched CRO Targeted Diagnostics Dashboard
  • Created a tracker for all in scope Clinical Data Providing vendors & Clinical Research Organizations, within GVOO, to enhance effectiveness, accuracy, source of truth-based approach, and cross functional collaborations with GAMs/GOMs (Global Alliance Leads, Global Outsourcing Managers) and Clinical Trial Management
  • Provided training of all clinical vendor oversight processes within GDO on Partnership & Study level to Global Alliance leads, Global Trial Managers, OPLs, GVOO team members, and other cross-functional BMS teams, for rollout, and uplift of applicable vendor oversight activities, to ensure adherence and efficient execution activities, to drive communication, assessment, and due diligence
  • Created GVOO pillar processes and BMS Quality month-related presentation support for GVOO team & leadership
  • Reviewed and updated Quality Agreements
  • Supported standardization of third party risk management, vendor oversight requirements, oversight plan template creation, updates and reporting (e.g
  • Governance Charter consolidation Vendor Oversight and Trial Plan, Issue Escalation, KPI/KQI templates etc
  • For CROs & CDP vendors)
  • Created Reference Guides as SME, to improve accuracy and proper utilization of updated BMS systems, and existing processes, while establishing, and embedding best practices, improving existing oversight templates, and periodically updating current GVOO SOPs, WI, and other guidance documentation for multiple processes to support GVOO, Global Trial Managers (GTMs) & Global Vendor Alliance team members
  • Collaborated with vendor onboarding, audit, inspection readiness, functional assessment, due diligence, corrective, and preventive action (CAPA) responses, activities, and overall vendor management
  • Provided additional training regarding VO processes and templates to ensure audit, inspection readiness, and compliance to GxP, GCP requirements and to ensure adherence and efficient execution of Clinical Data Provider & Clinical Trial related activities
  • Provided end-to-end primary GVOO support to Global Alliance Directors and teams of Imaging, (clinical Biomarkers & bioanalytical support) Specialty, and Central Labs, eCOA and IRT categories and participated as a primary point of GVOO contact in Operating Management Committee, based governance meetings for three categories; Imaging, IRT and Foundational CRO vendors, and provided subject matter expertise
  • Collaborated with Global Alliance leads, managing stakeholder engagement via cross-functional teams and vendors, to ensure seamless alignment of GVOO procedures and requirements, driving communication for GDO VO and functional assessment
  • Provided process analysis leading to functional improvements, through executed, cross-functional collaborations with Strategic Sourcing & Procurement (SS&P), Data and Vendor Quality, QA & Compliance teams, internal and external Global Alliance business leads, and Vendor Enablement team members, through GAP Analysis, Data analysis, Quality Agreement, MSA, LSA, and additional contract reviews for GxP, and Quality Language.

Business Operations & Strategy Analyst /BizOps

Johnson & Johnson – Janssen Biopharma / Infectious
06.2017 - 01.2021
  • Alios Biopharma), South San Francisco /Raritan NJ, Infectious Diseases & Vaccine (ID)TA, – Jan 1st 2021
  • End to End /Life cycle management of Purchase Requisitions and Purchase Orders within the ID TA Department
  • Cross functional business engagement through managing the needs and expectations of the Business to drive satisfaction, growth, and value-added support, while ensuring compliance and alignment to J&J’s procurement and organizational standards and strategies, to providing complete support within Infectious Diseases TA as a primary point of contact for teams in Clinical Operations, Research, Early Development, Clinical Drug Development, Clinical Trials, Discovery Sciences, Oligo CoE, CMC & IT sectors, SaaS, Hardware & Software procurement
  • Provided clinical operations, contracting and direct outsourcing support, to ensure systematic, compliant, and efficient management of contract administration and processing while maximizing operational performance and minimizing risks
  • Managed interactions with J&J contracted global suppliers, including relationship building, data review and analysis, key performance indicators and quality management, development, and processes of continued improvements
  • Provided end to end Procurement, requisitioning, PO creation and management, and goods receipt, invoice processing, payment, supplier issue resolution/help desk, cash flow optimization, tactical buying
  • Assisted with the development and maintenance of the strategic direction of the BizOps Team’s Business Operations Strategy & enablement, ensuring alignment to the strategic goals and standards of the ID TA’s and its overall vision, objectives, and function
  • Collaborated and liaised in a cross functional alignment with Janssen R&D’s Procurement strategy, process & policies, compliance & risk management, data management, reporting & analytics, communications, change and project management, organizational management and communications, training, knowledge management and market intelligence
  • Liaised with internal & external business partners, stakeholders, and vendors from Finance, PMO, R&D Procurement leadership, Regulatory Affairs, HCC, eMP/eMC Contract Management Tax, Legal, Global Services affiliates etc
  • Provided effective coordination, regarding contract request submissions via eMC, onboarding support to my BPs, ad hoc J&J systems and PC troubleshooting, and reconciliation, training and guidance, implementation of best practices, expedited payment requests, open PO management & reporting, invoice approvals and rejection, credit/debit memo request submissions, receipt postings, invoice submission issues, invoice mismatch root cause analysis, and reconciliation processes, PO increase, PO Change and PO closures
  • Initiated and assisted with continuous operational and process improvements efforts by:
  • Identified and troubleshooted issues regarding operations, purchasing, procurement and payments, while collaborating with scope owning teams and assisting with systems issues for ARAVO, ARIBA, eMP, eMP enhancement, eMC etc.) to improve fast, accurate and more effective processing flows for PR/PO and payments
  • Created Service Level Agreements’ step by step processes for Confidential Disclosure Agreements (CDA), Service Agreements (SA), Material Tr
  • Transfer Agreements IN/Out (MTA), Sponsorships Agreements, Totality Processes, CTAs and finalization and close out of Clinical Agreements etc
  • Integrated effective business processes for requisitions processing, invoice, goods receipt and payment processing, Supplier Issue Resolution/Help Desk, Cash Flow and saving optimization
  • Provided Data analysis, via Reports management, utilizing Tableau & Power BI and Pivot Table creations
  • Provided supplier and vendor relationship management in areas of:
  • Supplier Adds, Contracting processes, review of WO, MSAs, LSA, MLSA, MSPA, COS, COs, and PR / PO processing
  • Vendor bidding, proposal RFI, RFP processes, ARAVO system access, edits, updates related supplier support
  • Supplier engagement to improve invoicing matters, and invoice mismatch reconciliations for faster payment processing
  • Created, maintained, and managed the BizOps team’s Document Repository SharePoint Site for Process Steps, Job-Aids, QRGs, guidelines, WI, SOPs and integrated Alios business BOPs in all areas of Business Operations & Strategy
  • Managed expectations of the business to ensure compliance to procurement standards and alignment with procurement strategies and the organizations’ current goals, objectives and strategies
  • Provided in-depth training to 29 VWR catalyst, and Business Support Concierge (BSC) team members
  • Supported R&D Supplier Diversity Team’s organizational goals and provided extensive SDI and supplier management experience.

Compliance Analyst R&D Procurement

Johnson & Johnson
07.2016 - 03.2017
  • Managed JRP Resume Library & Training Curricula for the entire Janssen R&D Procurement, for Audit Readiness related projects – achieving 100% compliance, by designing a tracker and achieving 100% compliance
  • Primary Point of Contact for ARAVO set up and Supplier Approver Process for Local & WW management members
  • Created Work Instructions for ARAVO Approver Process and trained summer intern and CO-OP in supplier database, and SD team related activities in Aravo and other J&J systems
  • Managed all excluded R&D suppliers from R&D ASL (Approved Supplier List) in the Enterprise/Combined ASL to maintain consistency between Pharm & Enterprise ASL Sites
  • Completed Compliance Wire Training to assign & credit CW trainings to all JRP employees
  • Obtained Document Control Function and completed Document Obsolescence and other related activities in TruVault
  • As a JRP Supplier Diversity Team member, managed Diverse & SBA supplier e2e certifications and conducted spend analysis via Tableau, contributing to the growth of J&J R&D’s Credo and small business-related Global Diversity Spend and Supplier Diversity & Inclusion corporate initiative, while building strong relationships with diverse suppliers, and achieved a high number of successful minority & woman-owned certification completions uploads, plus small business updates in Aravo.

Category Analyst

Johnson & Johnson, Raritan, Sunrise Systems
03.2015 - 06.2016
  • Analyzed & approved requisitions in Ariba, in alignment with JRD’s procurement policies & procedures in all J&J Therapeutic areas, Oncology, Pulmonary Hypertension, Infectious Diseases & Vaccines, Cardiovascular & Metabolism, Neuroscience & Immunology
  • Provided mismatch reconciliation resolutions via invoice mismatch analysis, via step-by-step processes to end users
  • Resolved daily ad hoc issues and troubleshooting initiated by suppliers, business partners, and end-users
  • Started a 2016 Cost Savings Spreadsheet to capture and record the LSSE Category’s cost savings
  • Monitored and flagged all incorrectly approved VWR requisitions, capturing them in a detailed spreadsheet.

Education

Master of Business Administration - MBA - Management

DeSales University
Center Valley, PA
06.2011

Bachelor of Arts Degree - B.A. - Psychology

University of Connecticut
Stamford, CT
05.2004

Associate of Arts Degree – A.A. - Liberal Arts

NCC
Norwalk, CT
05.2001

Skills

15 years relevant experience at biotechnology, pharmaceutical industry with Clinical Development, Clinical Trial Procedures and processes, CRO and Clinical Vendor Selection, Qualification and Oversight, for clinical lab operations

Experience managing Central Laboratory Study startup, Site Management and Core Metrics & KPIs for Ph1-3 Trials

Experience with Vendor Management, Operations and Clinical Oversight

Excellent organizational and problem-solving skills to multi-task in an extremely fast-paced environment with tight timelines and competing priorities

Solid understanding of end to end clinical trial process

Demonstrated effective communication skills with internal and external stakeholders, leadership, and other cross-functional team members

Project management

Budgeting and forecasting

Risk management

Scope management

Cross-functional collaboration

Contract management

Accomplishments

  • Certificate of Recognition from J&J’s WORKSENSE Program, for going above and beyond in providing services.
  • Exceeding Expectations - 2017 Year End Performance - Encore Awards - July, 2017 & May 2018, Platinum Encore Award from J&J HQ - March 2019.
  • J&J Inspire Award for providing necessary eMP NA access to GCDO Trial Leader, managing COVID19 projects – May 2020.
  • J&J Inspire Award from SR Director of OligoNucleotide center of excellence - in recognition of achieving exceptional results.
  • Super User of CTBP based Global Vendor Oversight Owned CDREP.

Certification

International Council for Harmonization (ICH) guidelines,

Good Clinical Practices (GCP),

Annual Health Care Compliance Training

Clinical Trial Process Training

 Certificate of Recognition from J&J’s WORKSENSE Program, for going above and beyond in providing s

Managed the JRP Resume Library and Training Curricula for the entire Janssen R&D Procurement team, with a focus on audit readiness-related projects, achieving 100% compliance by designing a comprehensive tracking system.

Completed Compliance Wire Training to assign & credit CW training to all JRP employees

JRP Supplier Diversity Team member, managed Diverse & SBA supplier e2e certifications and conducted spend analysis via Tableau, contributing to the growth of J&J R&D’s Credo and small business-related Global Diversity Spend and Supplier Diversity & Inclusion corporate initiative

Languages

Hungarian
Native or Bilingual

Timeline

Project Manager - PM / Operational Excellence Team

Daiichi Sankyo
09.2023 - 02.2025

Project Manager- Vendor Management

Boehringer Ingelheim, SpectraForce Inc
01.2023 - 09.2023

Vendor Manager III

TD Bank
07.2022 - 01.2023

Gilead Sciences / Senior Manager, Vendor Qualification Lead

UniconPharma Inc
01.2021 - 07.2021

Business Operations & Strategy Analyst /BizOps

Johnson & Johnson – Janssen Biopharma / Infectious
06.2017 - 01.2021

Compliance Analyst R&D Procurement

Johnson & Johnson
07.2016 - 03.2017

Category Analyst

Johnson & Johnson, Raritan, Sunrise Systems
03.2015 - 06.2016

Vendor Oversight Process Manager

Bristol Myers Squibb
12.2010 - 01.2021

Bachelor of Arts Degree - B.A. - Psychology

University of Connecticut

Associate of Arts Degree – A.A. - Liberal Arts

NCC

Master of Business Administration - MBA - Management

DeSales University
Judith VekonyProject Manager