Project Manager Financial Analyst

Nick Douglas

***** *** ** ****** ***

Lake Forest, CA 92610

(M) 203-***-****

e-mail: ******@****.***

EXPERIENCE SUMMARY

Multilingual MBA in International Business with 8 years of international experience. Fluent in Spanish, Italian, and English. Speaks Portuguese and some German. Varied experience in finance as Global Controller, Finance Manager and Sr. Financial Analyst. Work experience includes: finance, multiple insurance lines, hospital/healthcare operations, pharmaceutical and manufacturing industries. Eighteen years of broad IT experience. Expertise includes pharmaceutical CRM and Veeva Vault eTMF and regulatory implementations management, Sarbanes Oxley compliance, IAS, IFRS, US GAAP, Six Sigma methodology, SDLC Agile and Waterfall processes, Medicare/Medi-cal, HIPPA, FDA regulations, GXP, GCP, GMP, managing products through the drug development and clinical trials cycle, managing outside and offshore development teams, change management, business process development including writing SOPs, analysis of financial data and financial statements, project management using SDLC, and IT project management. Expert in Windows 2000, MS Project, MS Project Server, Smartsheet, Outlook, Word, Excel, Excel macros, Visio, Sharepoint MOSS 2007, Hyperion Essbase, Hyperion Financial Management, Access, PowerPoint, LIMS, Medidata and Veeva Vault eTMF, RIMS, Salesforce, Business Objects, Business Objects based Global Data warehouse, Trackwise, JIRA, AWS, and some SAP. Expert in manipulation and analysis of large data sets using pivot tables and lookup macros. Completed training in PMBOK and Agile Project Management at Pfizer. Veeva Vault Certified Administrator.

PROFESSIONAL EXPERIENCE

CONSULTANT

Smith & Nephew

Remote (8/23- 12/24)

Sr. Project Manager (through VACO Consulting)

Sr. Project Manager in SN IT responsible for migration of clinical study data for Trial Interactive to Veeva Vault eTMF. Managed upgrade of PMPA (Post Marketing Performance Analytic). Project manager on Clinical Data Lake project using Databricks solution on AWS platform. Both Medicare and Medi-cal encrypted data flowed into the Clinical Data Lake from Net Health and other sources. Work with various clinical data bases and clinical study information for sources worldwide. Used Smartsheet, MS Project, Sharepoint and Excel to manage project plans and move and manipulate clinical study data.

CONSULTANT

Becton Dickinson

Remote (11/22-6/23)

Sr. Project Manager, (through Amerit Consulting)

Sr. Project Manager responsible for upgrades of eIFU ( Electronic Instructions for Use) application and PIM (Product Information Management) application. Responsible for all management of project timelines as well as management of four outside vendors, two of which managed SaaS for the applications. Upgraded additional workstreams of Qarad and asynchronous during work upgrading eIFU and PIM. Both applications were GXP applications which were maintained and upgraded in regulated and validated environments following B&Ds SDLC processes.

CONSULTANT

Biogen

Remote (11/21-11/22)

Sr. Project Manager, (through SGS Consulting)

Sr. Project Manager responsible for GRIT (Global Regulatory Information Tracking) a RIMS (Regulatory Information Management System). Responsibilities include management of internal and offshore teams of business users, developers, and outside vendors for this SaaS Cloud application on AWS. Responsible for upgrade of application in GXP regulated and validated environments. Used Smartsheet and MS Project to manage project plans.

CONSULTANT

Amgen Inc.

Remote (2/21-6/21)

Sr. Project Manager, Remote (through SMCI)

Sr. Project Manager for OM Divestiture with Cytokinetics. Responsible for Commercial, Operations, Global Health and Research IS functional areas transmissions of a data related to two molecules in joint development between Amgen and Cytokinetics. Worked with Business, IS, Quality and Cytokinetics to successfully transmit all relevant data in accordance with the Transfer Service Agreement (TSA) deadlines and processes. Responsible for reporting and managing progress to PMO.

CONSULTANT

Amgen Inc.

Remote (4/20-12/20)

Project Manager, Remote (through Ampcus Inc.)

Project Manager for Enterprise Cyber Resiliency (ECR). Responsible for project planning for enterprise implementation and upgrades of three applications CDS, LMES and CIMS at five sites while maintaining GMP and GCP. Worked with and managed outside vendors and FTEs to create and update project plan and drive project team work on applications and benchtop segmentation in line with business need for protection from cyber attacks and natural disasters.

Medidata Solutions Inc.

Project Manager, Remote (1/18-3/20)

Part of Professional Services responsible for Regulated Content Management (RCM). Project Manager responsible for all client implementations of eTMF, SOP products, and End of Study Media (EOS). Used Agile development process for installation and configuration for each client. All clients were put on AWS platform. Responsible for client management and project team management from RFP through production implementation. Used Waterfall and Agile techniques in product development. All projects were managed using Smartsheet.

CONSULTANT

NeoGenomics Laboratories, Aliso Viejo (12/16-12/17)

Sr. Program Manager (through Kelly Services Inc.)

Sr. Project Manager responsible for development, implementation, management and installation of 21 CFR Part 11 compliant (LIMS) LabVantage v8 systems for the entire company. Responsible for the implementation and validation of Definiens Tissue Studio application. Managed the development of the applications by onshore and offshore teams. Reported to senior leadership team on progress of validation. Created templates and SOPs for validation process and operations.

CONSULTANT

Microsemi Inc. Aliso Viejo (5/16-12/16)

Sr. Project Manager (through NTT Data)

Sr. Project Manager responsible for managing outside vendor development of CRM application for numerous business units within company. Worked with senior IT managers to create strategies to improve adherence to SDLC development guidelines by implementing best-practices discipline.

CONSULTANT

Amgen Inc., Thousand Oaks, CA (1/16-5/16)

Sr. Project Manager (through Planet-Pharma Inc.)

Sr. Project Manager responsible for the implementation of mySOP cloud-based application enterprise-wide. mySOP is a validated application used in manufacturing plants worldwide to supplement SOPs with videos that demonstrate GMP. Managed outside development team Mavenwave and internal resources. Liaised with business lead and reported on a monthly basis to the Steering Committee.

CONSULTANT

Edwards Lifesciences Inc. THV Clinical Affairs, Irvine, CA (12/14-11/15)

Clinical Systems Project Manager (through INFOSYS)

Project Manager responsible for the upgrade of the existing RAVE and CTRM applications for THV Clinical Affairs. Also Project Manager responsible for the implementation of Veeva Vault eTMF (electronic Trial Master File) for the U.S. and full migration of all key study documents for Regulatory Affairs. Fully responsible for managing outside vendor Veeva Inc., internal project team and had full responsibility for project budget.

CONSULTANT

Pfizer Global Research and Development, Business Technology, Groton, CT (7/14 –10/14)

Project Manager (through Atlas Data Systems)

Managed the testing, upgrade and reverse engineering of the Enrich application. Enrich is used to evaluate the financial viability of drugs and portfolios of drugs in all phases of clinical trials. Managed outside vendor responsible for creating, maintaining and upgrading the cloud–based and database servers that run the application. Worked with Clinical Portfolio Management and Business Technology departments to document and test the application.

CONSULTANT

Alexion Pharmaceuticals, IT Validation and Compliance, Cheshire, CT (8/13-6/14)

Project Manager (through QPharma Inc.)

Managed the Global Corporate Document Control Project (GCDC) (eDMS). Was responsible for $5 million budget for the project and managing the work of two outside vendors (CSC and Paragon Consulting). Worked with Quality and Manufacturing business to implement document management solution. Project was a global document management system that was validated and regulated. System controlled Quality and Manufacturing as well As Trial Master Files (TMF) submissions and documentation for drug development. eDMS replaced virtually all document management systems within the company including NextDocs.

At same time as implementation completed a business data migration of all company documents. Supervised both the implementation vendor (CSC) and data migration vendor (Paragon Solutions) development work to complete the project within timelines.

CONSULTANT

The Travelers, Strategic Planning and Execution, Hartford, CT (2/13-6/13)

Sr. Project Manager (through Corporate System Associates)

Managed a Business Insurance-wide Change Management Initiative working with Human Resources. Rolled-out training schedule and process for 9000 employees in Business Insurance Unit of The Travelers.

CONSULTANT

Pfizer Inc. Worldwide Safety and Strategy, Groton, CT (6/12-12/12)

Project Manager (through Talon Consulting. Inc)

Project Manager responsible for creating and maintaining a FTE resource model for Worldwide Safety and Strategy and Epidemiology. Worked with Safety staff and Leadership Team to model FTE demand under numerous scenarios. The FTE model will be used to predict and manage resources use to keep Pfizer Inc. in compliance with FDA and company standard across entire portfolio. Responsible for using Business Objects Business Intelligence application to validate and monitor results of model versus the activity tracking for Worldwide Safety and Strategy. Heavy use of Business Objects and Pfizer Global Datawarehouse for data pulls.

CONSULTANT

The Hartford Insurance Group, Simsbury, CT (10/11-6/12)

Sr. Project Manager (through TATA Consulting)

Responsible for Small Commercial Lines Data Extract project delivery. Data extract was used by Web Analytics Team to cross-sell offline and online clients. As Project Manager managed both onshore and offshore development teams to bring the project in on-time, and under budget.

Project Manager for the Business Intelligence Municipal Tax Project. Project identified insured clients by global positioning to accurately assign correct tax rate for numerous insurance lines of business. This project was business critical as the ability to identify the correct tax rate for each client was a compliance issues with the state tax boards for 13 affected states.

CONSULTANT

CIGNA, Windsor, CT (2/11-5/11)

Sr. Project Management Specialist Call IT (through ICONMA)

Project Manager responsible for Computer Telephony Implementation for GDS BPO. Project consisted of using existing LAN networks and creating and implementing a VLAN network using Virtual IP addresses to route claims and informational calls correctly. Also project manager responsible for coordinating Call IT's compliance with IE8 company-wide implementation in Sept. 2011.

CONSULTANT

ESPN Inc., Bristol, CT (8/10-12/10)

Sr. Financial Analyst for International Finance Department (through Stratigi Partners)

Sr. Financial Analyst responsible for reporting and financial analysis on several international entities within ESPN International. Responsible for all analysis of variance, P&L variances for entities, entity reconciliation, budgeting and forecasting on a monthly basis for the EMEA Region.

CONSULTANT

Pfizer Inc., Groton, CT (3/10-8/10)

Project Manager for Pfizer Diversified Business (through COMSYS)

Project Manager responsible for completing all integration project work from initial charter to completion of integration of all Pfizer Diversified Business units eClinical 5.0 clinical studies into the current Pfizer environment using Pfizer’s SDLC process. Pfizer Diversified Business comprises all OTC drugs and consumer goods in the Consumer Health Division. Directed the work of project team including assisting and supervising the business analysis in the gathering of the system and the business requirements to complete the project. Created and managed the Wyeth/Pfizer Integration team's Sharepoint site. Created the format and content as well as calendar to track and monitor progress on all Dev Ops integration projects.

CONSULTANT

UTC, Hartford, CT (2/10-3/10)

Project Manager for International Tax (through KForce)

As the Project Manager for International Tax, was responsible for completing and coordinating interactions between UTC Corporate Legal, Accounting, Treasury, Tax departments, domestic and international business units, and outside advisors to complete complex financial transactions. Transactions included: M&A, selling and closing businesses, and creating new legal entities to optimize corporate tax structure and financial results.

CONSULTANT

Pfizer Inc., New London CT (5/07-12/08)

Sr. Project Manager (through Visual Technologies Inc.)

As a Sr. Project Manager on Clinical Trials Relationship Management Portal Project (CTRM) completed $600,000 project on time and on budget. Managed a team of up to 14 throughout project lifecycle using Waterfall and Agile project management techniques. The CTRM Portal was a Sharepoint MOSS 2007 COTS application modified using .NET. The Sharepoint Portal was used by clinicians to collaborate on ongoing clinical trials and report and share information and results of clinical trials worldwide. Responsible for planning, managing outside vendor application development, requirements gathering and stakeholder acceptance, design, build, UAT and system testing, and full implementation into the production environment for application. Served as Administrator of the CTRM site until a BAU administrator could be found and trained. Worked with clinical trials business lead on a daily basis to implement business solution. Created training material and processes for new administrator. Trained new administrator on features of the CTRM application. Used Microsoft Project server to create project plan, resource level and report on milestones sand project timelines.

Worked as Project Manager on a Six Sigma Financial Business Intelligence Process Improvement Project for Worldwide Purchasing Organization. Added Pegasus application to Trackwise change management system. Trained support staff on use of Trackwise system. As the Project lead on this Six Sigma project I was responsible for providing both business analysis and operational analysis to management, and making recommendations to sales and marketing areas on how to reduce cycle time for project approval and reduce rejection rates. Recommendations to management were implemented and saved $1.4 M by reducing cycle time and lowering rejection rate in WPO organization. Used information from Pfizer’s Global Datawarehouse (GDW) to create analysis and business recommendations.

CONSULTANT

XL Insurance Company, Hartford, CT (2/07-5/07)

Project Lead (through Systems Group Inc.)

Responsible for managing business and IT relationship during financial change project. Responsible for 4 common modules in finance and IT department during business process re-engineering project. Reengineering brought together common financial reporting platform for P&C insurance business for XL worldwide. Responsibilities during this project were to make sure that the ETL portion of the process was completed successfully and fully tested in the U.S. and abroad before the full implementation of the platform.

CONSULTANT

Rib-X Pharmaceutical Inc. New Haven, CT (1/07-2/07)

SOX Consultant (through Accountants Inc.)

Responsible for creation, review, and completion of all Sarbanes Oxley documentation. Full responsibility for Sarbanes Oxley process narratives, audit maps, and audit test scripts for all company processes. Reported and reviewed all results to VP/CFO of company in preparation for Sarbanes Oxley attestation before IPO. SOX remediation was completed on time for initial attestation by auditors.

CONSULTANT

Pfizer PGRDi, New London CT (9/05-9/06)

Project Manager (through BLC Consulting)

Project Manager responsible for completing the upgrade of Hyperion Performance Scorecard from version 3.1 to 4.1.1, within the SDLC process framework. SDLC process follows PMBOK standards. Upgrade was delivered on-time and on budget to 4 business lines with a total of 2000 end users, mostly senior management. Budget was $600,000 and managed a team of 5 developers. HPS was used for a variety of tasks from measuring lab results to reporting financial data.

Project Manager responsible for managing Hyperion System 9 Foundation project to completion using SDLC process. Hyperion System 9 integrates all Hyperion applications and allows the applications to share information. Integrated all Hyperion systems with Trackwise platform for change management control. Responsible for full testing of integration. As project manager responsible for the full suite of system and project documentation and client acceptance necessary to complete the project.

CONSULTANT

Atlas and Polar Airlines, Purchase NY (6/05-9/05)

Business Analyst for Technical Operations and Line Operations (through Resources Global Professionals)

Responsible for business analysis and recommendation to improve forecasting and trends of both line and freight maintenance monthly expenditures. Reconciled payments to outside service providers to both Atlas and Polar Airline’s JDE ledger accounts. Recommended changes in accrual process to improve accuracy in JDE ledger accounts.

CONSULTANT

Alstom Transport Inc., New York City, NY (5/04–5/05)

Finance Manager for the America’s Controlling and Reporting

Manager responsible for all the financial reporting using Hyperion HFM application for North America and South America to the region’s senior management. Responsible for driving improvements in financial results region-wide through analysis of results and close interaction and cooperation with 7 country Finance Directors. Budge for Sales and Service was $800 million. Completed week long training by Deloitte on IFRS. Then converted North America and South America to IFRS and IAS standards

Responsible for all the preparation, analysis of KPI’s, P&L analysis, and presentation of financial results to senior management in the region and in Paris.

EDUCATION

CALIFORNIA STATE UNIVERSITY HAYWARD, Hayward, CA

MBA, Business Administration, 1995

Major International Business, Concentration International Finance

CALIFORNIA STATE UNIVERSITY HAYWARD, Hayward, CA

BS, Business Administration, 1994

Double Major: International Business, Concentration Finance; Managerial Economics

UNIVERSITY OF CALIFORNIA AT SANTA BARBARA, Santa Barbara, CA

BA, Psychology, 1981

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