Candidates About

 

 Darryl Francis Corts

 

J&J Reference: Timothy D. Laverty – Sr. Director CMC-Regulatory Affairs, Centocor, Horsham-Malvern, PA (Now Janssen)

“…From an IT perspective, this guy was pretty darn amazing. He understood a difficult change control system and made it work effectively and efficiently”. He was able to take an all paper change control system that consisted of various formats, extract the various data, and, after creating a universal database, import all this data in a uniform system that would be accessed by all areas, including the FDA. The system he created was robust, clearly defined and simply amazing...” 

 

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 the design, development, process improvement, and implementation of high quality, error free, cost-effective solutions.

·         Designing of solutions that 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. 

 

Key Applicable Experience:

·         Led project teams in implementing and designing both EAM and ERP systems, Clinical Trial Portals, UDI/IDMP and custom applications for FDA/EU 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 ERP, EAM, 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.

·         Admin and PM for Windows 2012 & RHEL 7 Dell & HPE servers for file shares, email, database, etc.

·         Admin and PM for Liquent Insight Manager, Publisher, and Viewer Suite

·         Admin and PM for Adlib Enterprise Server

·         Admin and PM for QlikTech BI Suite of products

·         Experienced working with finance business processes

·         Experienced with GxP and regulatory compliance processes

·         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 the 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 2010/2013, 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, The SAS System, Cognos, 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

·         Research capabilities, business and technical writing experience, and knowledge of medical and software coding languages (SAS, R, T-SQL, DQL, PL/SQL, and C#)

 

PROFESSIONAL EXPERIENCE

 

Merck & Co., Inc. (NTT Data, Inc.) Upper Gwynedd, PA                                                  10/2017 – 12/2017

Senior Project Manager

 

Senior Principal Consultant – ORION 3.9 to 4.0 (PAREXEL Liquent Insight Publisher 6.1 CHF 4) upgrade and Data Harmonization/Integration (IDMP) dual workstreams actively managing the projects inclusive of Merck workforce, partners and suppliers short term engagement for Initiate and Planning phases.

 

 

J&J / Janssen Pharmaceuticals (Stonehurst Solutions) Horsham, PA                       05/2017 – 09/2017

Senior Project Manager

 

Senior Principal Consultant - PRISM Program with primary project focus on Risk Intelligence Repository (RIR) Release 1 (legacy case reports migration and deployment of Pharmacovigilance [PV] Reports safety systems), and Release 2-ETL/Reporting DW development and deployment for J&J/Janssen and RxLogix/ARISg multiple work stream solutions.  Manage client expectations and project work streams overall conduct.  Manage RAID logs. Manage integrated project planning, baselining, and PMO reporting with Microsoft Project 2016, PMx, and Tableau.

 

• Ensure that the infrastructure systems/project environments are operational 365/24x7.
• Coordinate project deliverables and deployment with all areas of the company including the business representatives, technical team, and supporting applications.
• Identify/work with individuals that will perform signatory TrackWise and HP-ALM review and approval tasks for project control documents, SDLC, and validation deliverables.
• Ensure that all documentation has been completed.
• Communicate technical details to downstream applications.

• Provide analysis/resolution to E2B issues involving US and EU regulatory agencies.

 

Cambridge Biomedical (Navitas Life Sciences) Cambridge, MA                                  09/2016 – 03/2017

Senior Principal Business Architect / Quality Analyst / Migration Lead

 

Senior Principal Consultant - at Cambridge Biomedical, Otsuka Pharmaceuticals, and Sparta (contracted thru Navitas Life Sciences) for CARA Documentum upgrade, verification/validation, and migration project.  Senior Technical Writer for FRS, SDS, URS, etc. for CARA upgrade and IDMP integrated TrackWise application. SDLC and Quality deployment and documentation Amazon Web Services (AWS) cloud solutions administration and support EC2, S3, RDS, OpsWorks, etc. 

 

Pfizer, Inc. (Chaucer Life Sciences) Groton, CT                                                                   06/2016 – 08/2016

Senior Quality and Business Analyst (short term contract)

 

Senior Principal Consultant - Hospira (contracted thru Chaucer America, Inc.) for CMA integration content and data migration project; GDMS data quality verification/validation.

 

fme US, LLC (fme Group – Life Sciences) Danbury, CT                                                  03/2012 – 06/2016

Sr. Project Manager / Sr. Business Analyst / Sr. Technical Writer / Sr. Lead QMS Auditor-Analyst

 

Principal Consultant…

 

Novartis (Dallas, TX)

·         DES and OmniRIM migrations (Quality/Validation process and Migration Center technical and functional documentation)

·         Build OQ Document and Test Scripts for the RM4NVS application in development (based on Documentum RM, RPS and PRM functional specifications).

 

Medtronic (Minneapolis, MN)

·         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.

 

Lyondell (Houston, TX)

Consulting as System Administrator

·         Adlib Enterprise 5.4.2 POC/Pilot installation, configuration, and testing.

·         Documentum Connector

·         SharePoint Connector

 

CSL Behring (King of Prussia, PA)

·         EMC Documentum Life Sciences Suite, eTMF, Q&M, and R&D design, test, and deploy.

 

Adlib (fme AG)

·         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.

 

Allergan (Irvine, CA)

·         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.

 

Merck-Serono (Rockland, MA)

·         Alfresco to Zinc Ahead Maps migration.

·         Design and deploy an eArchive application solution for all legacy records.

 

Cenveo (Stamford, CT)

·         D2 Documentum implementation (full lifecycle DAM/ALM) senior project management; includes functional, technical, quality, and business analysis.

 

Boehringer Ingelheim (Ridgefield, CT)

·         eRooms to SharePoint cleanup, staging, & migrations.

·         Documentum functional & technical engagement managing the data analysis, mapping, & cleansing--master dictionary data & business requirements analysis for CTMS & CTMF, clinical, Quality, CMC and global regulatory content & data migrations.

 

ICON Clinical Plc North Wales, PA                                                                                           01/2012 – 03/2012

Principal - Senior Clinical Database Analyst

·         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.

 

Pfizer Inc. Collegeville, PA                                                                                                          04/2011 – 10/2011

Senior Clinical Business & Migration Analyst

·         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.

 

Atlas Data Systems, Inc. – Elite Studio Merck Engagement, Upper Gwynedd, PA              09/2010 – 02/2011

Senior Clinical Business Analyst

·         At Merck & Co., (Upper Gwynedd – PA) Global Services MRL Documentum eRooms to SharePoint 2007 project as Senior Clinical Business Analyst under the Merck BA Studio Model for ensuring accurate and timely preparation and execution of integrated data and content migrations.

·         Bridge the gaps between MRL-IT and ECKM analysis in the 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.  

 

AstraZeneca, Wilmington, DE - eArchive Programme System                                     09/2009 – 03/2010

Project Manager and Senior Technical Writer

·         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 the AZ ARM Global eArchive Documentum project 

·         Designed, scripted, and performed test data E-T-L transactions from source systems to target staging areas 

·         Manage the 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

 

Merck & Co., West Point; Blue Bell; Wayne – PA                                                             09/2007 – 09/2009

Project Manager and Senior Clinical Business Analyst - (Documentum Migration [MIDAS])

·         Managed Paragon Solutions Pre-Clinical/Clinical technical and functional requirements-business and data analysis for the 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 the 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; Merck 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

 

Centocor R&D, Inc. Horsham, PA                                                                                              09/2005 – 08/2007

·         Review and analysis of the 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 the Medidata RAVE Architect application.

·         This brief downtime was to save the GCO client considerable time, effort, and expenses. In addition, the 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 the streamlining of multiple data sources, processes for centralized data warehousing, use cases, acceptance testing, test case verification and validation.

·         The 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                                                                                                                   

·         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 the development/use of custom applications. 

·         Maintained associated Clinical Trial Management System (CTMS) components for the 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 the development of quality standards and best practices for the CDA group, and ensures regulatory compliance in the SDLC development process. Issued final Process Improvement report.

 

Senior Scientific Database Analyst                                                                                                    

·         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 the 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 the FDA tracking requirements defined in the scope of the 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.

 

Associate Scientist                                                                                                                           

·         Contracted Documentum content and data migration position (Kelly Engineering) managing the 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 the European Union 

 

ERP / Manufacturing

 

Vertis, Inc. Chalfont, PA                                                                                                                               05/1994 – 08/2005

Senior Applications Project Manager / Systems Lead DBA / Senior Lead QMS Quality Auditor-Analyst

·         As the EAM/CMMS system owner managed the strategy/planning, design, development, deployment, and administration of all integrated applications for the Engineering Systems Group.   Defined and executed all user training requirements for each system modules 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) the issues log entries, lessons learned, change management system logs, risk management reports.

·         Manage the 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 the ETL team in content review, data extractions, imaging, transformations, validation, and loading to appropriate web servers.

·         Manage the “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)

 

Functional Expertise

·         Attend IS: Lawson and SAP team meetings

·         Review SAP implementation plans and provide input (if needed)

·         Evaluate current business strategies pertaining to Project Engineering, Procurement, and Plant Maintenance requirements

·         Write Business Process Procedures

·         Draft use cases and UAT scripts

·         Performed GAP Analysis: Current EAM to SAP: MM and PM project development feasibility

·         Advised on MM and AM user requirements relating directly to CMMS task management functionality

·         Critical Process and Data Mapping; Modeling of Business Functions

·         Develop Interfaces and Conversions

·         Data Cleansing and Migration to SAP: MDM vendor, equipment, and materials data

·         Determine External Data Dump Requirements for Trend Analysis, Daily Production Analysis, and Analysis for Asset Repair or Replacement

User Support

·         Help oversee completion of Requisitions and Purchase Orders

·         Monitoring of Purchase Orders processing to facilitate Accounts Payable

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