SUMMARY

• Results - driven Senior Project Manager and Clinical Business-Data Architect (with a Quality Management Systems Lead Auditor background-ISO9000/14000.experienced with Agile-Scrum-Sprints) successful at leading people and teams in teh design, development, process improvement, and implementation of high quality, error free, cost-TEMPeffective solutions.
• Designing of solutions dat emphasize innovative use of information technologies and tools to support large scale enterprise (SAP, Documentum, etc.) and global clinical (content and data management) business objectives.
• Extensive experience in leading small and large, complex, IT business prototypes and applications projects. Oversee development and support of projects on multiple technology platforms, including Web-based, Client-server, Mid-range and Mainframe.
• Led project teams in implementing and designing both EAM and ERP systems, Clinical Trial Portals, and custom applications for regulatory submissions, compliance, and tracking to clinical data management and data capture.
• Experience identifying, selecting, and managing external vendors (RFI, RFP, SOW, etc.)
• Experience in managing large ECCM and ECKM content and data projects from $500K to $24MM
• 8+ years’ experience with SAP R3 4.0b to 4.5, PM, MM, WM, PP, FICO, SD, SCM and SRM, etc.
• Senior ISO QMS Lead Auditor of manufacturing and/or software solutions
• Senior Technical Writer performing assessments and reviews of Quality and SDLC documents.
• Process Validation: Design and Development Controls, QA/QC, Process Control, and CAPA
• Perform Kaizen audits and analysis for continuous improvements
• Process and Data mapping and design (functional and technical in manufacturing, enterprise solutions management, clinical trial management)
• Design and/or review protocols for UAT, decision trees, functional verification, and process validation scripting
• Design and implement probability random sampling guidelines.
• Requirements for DQ, IQ, OQ, PQ, design, development, execution, and/or documentation
• Design and updating of teh Master Validation Plan document
• Risk Assessments and Analysis, creating and maintaining documentation
• Reports validation and test progress to client and other team members.
• Manages resources globally and across disciplines and levels of experience.
• Authors, reviews and edits full suite of GxP-required validation documents: requirements and design documents, validation plans and reports, test plans and reports, test scripts for all test phases, traceability matrices, change requests, risk assessments.

TECHNICAL SKILLS

Technical: Documentum 5, 6 and 7…and D2, SharePoint 2010/20103, QlikView, ADLIB PDF Enterprise, SAP R3, CTMS, CDMS, Medidata RAVE, jReview (formerly iReview), eResearch Technologies (eDC), PDS Express, Oracle Clinical, ClinTrial, Open Project, SQL Server, DB2, MySQL, Pervasive, Erwin, Visio, ORACLE, TOAD, Liquent, eCTDXpress, Teh SAS System, Cognos, QlikView, Crystal Reports, DW/BI, Microsoft Visual Studio...

Clinical System: Content-Records Management, Workflow Management, Data Management, Report Building, Quality Systems Management, Technical Management, Business Process Management, Workforce Management (Onsite/Virtual), Change Management, Risk Management, Software and Data Validation & Testing

Proficient in MS Office Tools: MS Project, MS Visio, MS PowerPoint, MS Word, and MS Excel

PROFESSIONAL EXPERIENCE

Confidential, NJ

Sr. Project Manager / Sr. Business Analyst / Sr. Technical Writer

Responsibilities:

• DES and OmniRIM migrations (Quality/Validation process and Migration Center technical and functional documentation)
• Build OQ Document and Test Scripts for teh RM4NVS application in development (based on Documentum RM, RPS and PRM functional specifications).
• Phase III SOW. Documentum migrations and Regulated DocBase Retirements; analysis, verification, and validation. Service NOW support for Documentum Global.
• Senior Business Systems Analysis (Quality Regulatory Process Team) for functional requirements, operational processes, data relationships and configurations. Align processes across business units, develop solutions to complex problems.
• Design/execute a communication plan for functional areas and related business and technical requirements.
• Liquent Insight Manager 5.x (eCTD) - RAD Migration strategy and execution for US and ROW, RAD Data Exchange, UDI and Product Licensing Specifications, DCTM upgrades, deployed license renewals applications to 8 BU’s; TOAD and SQL Developer data review and consolidation.
• Manage process improvement initiatives. Reverse engineer, upsize, and enhance master data management (MDM); with ETL processes and SQL/custom tools. Participate in Regulatory US and ROW data verification and validation. Initiate meetings and participate in scrum/sprints.

Confidential, Houston, TX

Consulting as System Administrator

Responsibilities:

• Adlib Enterprise 5.4.2 POC/Pilot installation and configuration.
• EMC Documentum Life Sciences Suite, eTMF, Q&M, and R&D design, test, and deploy.
• Manage POC for Documentum Servers, SharePoint Servers, vSphere 6.0 virtualization of VM Server for Adlib Enterprise 5.4 pilot deployment of transformation services.
• Installation and server configuration of application formats for Adlib farm transformations.
• Role of Senior Global Project Team Leader working with Allergan’s Regulatory Core Team Applications Support.
• Technical support: server configurations & optimization, break-fix, and cleanup. Service Now helpdesk systems and support; etc.
• Conduct and lead IQ & OQ validation (also review DQ & PQ, execute, and document) of Liquent Insight application servers and software upgrades.
• Liquent Insight Manager Admin and project upgrade 5.0 to 5.1 and Liquent Insight Viewer Admin and upgrade to 5.4
• Alfresco to Zinc Ahead Maps migration.
• Design and deploy an eArchive application solution for all legacy records.
• eRooms to SharePoint cleanup, staging, & migrations.
• Documentum functional & technical engagement managing teh data analysis, mapping, & cleansing--master dictionary data & business requirements analysis for CTMS & CTMF, clinical, Quality, CMC and global regulatory content & data migrations.
• Contracted (FirstPRO, Inc.) short-term (forecasted at eight weeks) technical engagement to diagnose and repair (including optimize and debug admin templates) of MS Access clinical trial financial / investigator management applications and reporting database functionality for migrations residing on legacy to target Citrix platforms.

Confidential, Collegeville, PA

Senior Clinical Business & Migration Analyst

Responsibilities:

• Contracted VIPER Program virtual deployment project team member working with program management in a matrix environment (TEKsystems, Inc.) for legacy Wyeth and Pfizer; assigned to Drug Safety/Metabolism, Clinical-GSSE, TMF, and Consumer-SA business analysis and migration requirements for mapping and delivering Buldozer specification builds.
• Regression Analysis and Testing, QC and data integrity checks; cleansing and/or enrichment; prepare use cases; creating test plans; pre and post production UAT-content verification; random and targeted validation…disaster recovery and business quality reviews. Review and submit changes to VIPER on-boarding/training documentation.
• Certificate awarded for innovative thinking in master database indexing and tagging of targeted migration objects. Position requires strong content-records and data management project skills and business client-SME onsite and/or virtual interaction.

Confidential, Blue Bell, PA

Senior Clinical Business Analyst

Responsibilities:

• At Confidential & Co., (Upper Gwynedd - PA) Global Services MRL Documentum eRooms to SharePoint 2007 project as Senior Clinical Business Analyst under teh Confidential BA Studio Model for ensuring accurate and timely preparation and execution of integrated data and content migrations.
• Bridge teh gaps between MRL-IT and ECKM analysis in teh business area knowledge base; identify, research, and/or resolve escalated issues or additional project requirements.
• Define and implement process improvement strategy and methods for data collection and synchronization.
• Participate as a Paragon Solutions Tech & Tools (TNT) team member doing business and process analysis
• Perform SLC technical writing and review SLC requirements; Application Architecture, Blueprints, Software Design Specifications, Traceability Matrix, Use cases, UAT Scripts, etc. requirements for teh AZ ARM Global eArchive Documentum project
• Designed, scripted, and performed test data E-T-L transactions from source systems to target staging areas
• Manage teh testing of integrated transformation and fidelity software tools selection processes for manual, batch load, API and/or command-line execution
• Draft testing criterion, SDLC, technical and functional analysis, and preservation documents for final tool selection
• Perform quality reviews of existing software development and validation documentation

Confidential, PA

Project Manager and Senior Clinical Business Analyst

Responsibilities:

• Managed Paragon Solutions Pre-Clinical/Clinical technical and functional requirements-business and data analysis for teh preparation, indexing, cleansing, transformation and enrichment of global (US, EU, Asia) Documentum, SharePoint, Lotus Notes, and share drive MRL documents and metadata; targeted for Drug Med, IT, Process Research, Pharmaceutical R&D, Global Supply Chain Operations, Safety Assessment, Bioprocess Pharmaceutical R&D, and Viral & Biologics Research.
• Conduct and participate in meetings for kick-off, appraisal, in-process, and delivery phases
• Design and implement custom applications for extraction, transformation, and loading (E-T-L) of content metadata for SIP-data file creation into Migration Center or Bulk Import functions
• Liaison with each business area representatives and off-shore vendors to define all formal requirements for rules, testing, validation, tools, backups, staging, disaster recovery, and disposal and retirement
• Design and/or execute validation and testing of simulation runs and production runs
• Prep and process content and metadata file attributes and mappings for legacy migration using Migration Center to Documentum application (MIDAS 6.x)
• Design cleanup and staging strategies; and enhanced methodologies
• Discovery and clean-up of teh current folder and file structures (includes drop-zone for migration center and bulk import executions)
• Identify, assign, and schedule project requirements and resources (task management)
• Identifying document and data prep requirements
• Design and implement disaster recovery processes
• Identifying and design automatic, manual, and/or hybrid cleansing and conversion methods
• Process improvement and implementation of tasks and new methodologies
• Manage and trained staff/team members and report to senior management (Director of Engagement and/or VP of Life Sciences; Confidential ECCM). designed and deployed project related training material.
• Assessments for future global migrations
• Strategic reviews for new technologies, tools, and techniques
• Apply Agile-SCRUM/Sprints, BABOK2 (IIBA), PMBOK5 (v4 - IBM), and ISO certification and training from referenced manuals
• Lessons learned and process improvement reviews

Confidential, Horsham, PA

Responsibilities:

• Review and analysis of teh Clinical Trial Management Systems (CTMS) for process improvement. Final analysis, in part, after careful review/revision of quality documentation (SOP, SOG, WI, and CC) and a thorough performance evaluation revealed several key CDMS flaws in teh Medidata RAVE Architect application.
• This brief downtime was to save teh GCO client considerable time, effort, and expenses. In addition, teh development and implementation of a low cost Global Electronic Change Control Operations (GECCO) prototype system for global .Net integration. Expected deliverables for each phase completed on or before scheduled target dates.
• This includes teh streamlining of multiple data sources, processes for centralized data warehousing, use cases, acceptance testing, test case verification and validation.
• Teh primary accomplishment was an error free delivery (100%) of quality FDA and clinical metadata and Regulatory Affairs content for system ingestion into future .Net production systems. Delivered a web based content library for referencing Regulatory Affairs and Quality Control assessments for IND, NDA, BLA, etc. globally during inspections all FDA submission documents.

Senior Clinical Data Analyst

Confidential

Responsibilities:

• Contracted CTMS position (Kelly Scientific) performing global clinical trials start-up front-end eCRF analysis, design, application development, and implementation using PDS Express, eResearch Technologies, and primarily with Medidata RAVE (Oracle/SQL Server) for eCRF design and implementation review; requirements gathering, cleaning and scrubbing of data, PLSQL querying, DTS - OLAP automation, warehoused data migrations, ETL-data loads using SAS and TOAD, UAT, jReview (formerly iReview) report building for Data Management, Use Cases, annotations, designing data quality rules and derivations, quality checks, verifying edit checks, and/or validation of custom functions along with teh development/use of custom applications.
• Maintained associated Clinical Trial Management System (CTMS) components for teh capture and/or loading of global clinical study data (Oracle), including, change management and document management resulting from post clinical trials monitoring.
• Provided leadership and contribute to teh development of quality standards and best practices for teh CDA group, and ensures regulatory compliance in teh SDLC development process. Issued final Process Improvement report.

Senior Scientific Database Analyst

Confidential

Responsibilities:

• Contracted Documentum content and data migration specialist (Kelly IT) performing change control process and relational database application development; quality document conversion and migration, business and data analysis; design and management for teh Worldwide Regulatory Affairs and Quality Assurance departments.
• Managed onsite and offsite manual and ETL - cleansing, scrubbing, and migration of existing QA/RA warehoused data sources to meet teh FDA tracking requirements defined in teh scope of teh project.
• Managed all UAT and Proof-of-Concept (POC) application testing and development.
• Drafted all SDLC documents, SOP, work instructions, guidelines, and training materials.
• Identified, communicated and clarified all data quality issues to process owners.
• Reverse engineer existing data systems with Erwin or Visio; coupled with data analysis and modeling of various databases for electronic BI information and document warehousing.
• Developed use cases and test scripts
• Tested integrated and non-integrated data migration and backend compatibility to existing GUI’s.
• Worked closely with R&D to develop .Net project scope for 2007 budget review and approval board.
• Contracted Documentum content and data migration position (Kelly Engineering) managing teh extraction and conversion, scanning, and indexing of FDA submissions and communications library for global access.
• Designed web-based reporting solutions and distributed CD/DVD versions to reference onsite during FDA inspections in teh European Union

Confidential, Chalfont, PA

Application Project Manager/Systems Lead DBA/Senior Lead

Responsibilities:

• As teh EAM/CMMS system owner managed teh strategy/planning, design, development, deployment, and administration of all integrated applications for teh Engineering Systems Group. Defined and executed all user training requirements for each system module authorized access. Manage all change requests, report builds, and system modifications to core modules and any integrated systems. Designed and implemented all backup and disaster recovery processes. Responsible for defining and executing for all automated KPIs, daily project work stream status reports, and key systems performance reports to executive management.
• Manage all phases of SDLC and RDLC, estimating, internal and external resource planning, project timelines, dependencies, and delivery planning of changes to external ERP, EAM, SCM, and/or CRM integrated applications. Review with senior management (VP of IT, Manager-Software Development) teh issues log entries, lessons learned, change management system logs, risk management reports.
• Manage teh strategy, design, and execution of all Engineering Systems hard copy, file shares, and client-server content (level 1-3 procedures, work instructions, guidelines…CAD drawings, etc.) and metadata to web based platform and user interface. Lead teh ETL team in content review, data extractions, imaging, transformations, validation, and loading to appropriate web servers.
• Manage teh “As Is / To Be” review and targeted technical and functional system requirements analysis for upgrading legacy systems to SAP R3 v4.5.
• Developed use cases and test scripts
• Report all findings to executive management or steering committees.
• SAP Responsibilities (EAM/ERP/SCM/CRM)