Nicholas E Douglas Sr. Project Manager

Sr. Project Manager

Smith & Nephew

Aug 2023 - Dec 2024 (1 year 5 months)

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 and Azure platform. Both Medicare and Medi-cal
commercial 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 for project management, ServiceNow for change management, and QMS for testing
documentation. Managed Agile JIRA meetings with outside vendors and used RAID logs to manage risks

Sr. Project Manager

Becton Dickinson

Nov 2022 - Jun 2023 (8 months)

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.

Sr. Project Manager

Biogen

Nov 2021 - Nov 2022 (1 year 1 month)

Sr. Project Manager responsible for GRIT (Global Regulatory Information Tracking) a RIMS (Regulatory
Information Management System) and change management for all applications. RBQMS and CTMS used
for quality management. 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, MS Project and RAID logs to
manage project plans.

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Sr. Project Manager

Amgen Inc.

Feb 2021 - Jun 2021 (5 months)

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.

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Project Manager

Amgen Inc.

Apr 2020 - Dec 2020 (9 months)

Project Manager for Enterprise Cyber Resiliency (ECR). Responsible for project planning using MS Project
for enterprise implementation and upgrades of three applications CDS, LMES and CIMS at five
manufacturing sites while maintaining GMP and GCP. Tracked and reported monthly CAPEX and OPEX
expenditures related to the project. 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.

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Project Manager

Medidata Solutions Inc.

Jan 2018 - Mar 2020 (2 years 3 months)

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. Created data analytics and KPI for eTMF. Recommended EDC and CTMS add-on where
appropriate. All implementations involved commercial data from each client which became part of
Medidata's commercial database for clinical analytics. Responsible for client management and project
team management and change management from RFP through production implementation. Used Waterfall
and Agile techniques in pro

Sr. Program Manager

NeoGenomics Laboratories

Dec 2016 - Dec 2017 (1 year 1 month)

Sr. Program Manager responsible for development, implementation, change 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.

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Sr. Project Manager

Microsemi Inc.

May 2016 - Dec 2016 (8 months)

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.

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Sr. Project Manager

Amgen Inc.

Jan 2016 - May 2016 (5 months)

Sr. Project Manager responsible for the change management and 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.

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Clinical Systems Project Manager

Edwards Lifesciences Inc.

Dec 2014 - Nov 2015 (1 year)

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. All historical
and current commercial data was moved into the new application. Fully responsible for managing outside
vendor Veeva Inc., internal project team and had full responsibility for project budget and timeline using
MS Project.

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Project Manager

Pfizer Global Research and Development

Jul 2014 - Oct 2014 (4 months)

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.

Project Manager

Alexion Pharmaceuticals

Aug 2013 - Jun 2014 (11 months)

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

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Sr. Project Manager

The Travelers

Feb 2013 - Jun 2013 (5 months)

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

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Project Manager

Pfizer Inc.

Jun 2012 - Dec 2012 (7 months)

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.

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Sr. Project Manager

The Hartford Insurance Group

Oct 2011 - Jun 2012 (9 months)

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.

Sr. Project Management Specialist Call IT

Cigna

Feb 2011 - May 2011 (4 months)

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.

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Sr. Financial Analyst

ESPN Inc.

Aug 2010 - Dec 2010 (5 months)

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.

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Project Manager

Pfizer Inc.

Mar 2010 - Aug 2010 (6 months)

Project Manager responsible for completing all integration project work from RFP and initial charter to
completion of integration and migration 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

Project Manager

UTC

Feb 2010 - Mar 2010 (2 months)

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:
Mergers and Acquisitions (M&A), selling and closing businesses, and creating new legal entities to optimize
corporate tax structure and financial results.

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Sr. Project Manager

Pfizer Inc.

May 2007 - Dec 2008 (1 year 8 months)

As a Sr. Project Manager on Clinical Trials Relationship Management Portal Project (CTRM) completed
$600,000 project on time and on budget. Part of the RFP and RFI process. Managed a team of up to 14
throughout project lifecycle using Waterfall and Agile project management techniques. Responsible for
tracking CAPEX and OPEX expenditure of project. 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
acceptan

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Project Lead

XL Insurance Company

Feb 2007 - May 2007 (4 months)

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.

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SOX Consultant

Rib-X Pharmaceutical Inc.

Jan 2007 - Feb 2007 (2 months)

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.

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Project Manager

Pfizer PGRDi

Sep 2005 - Sep 2006 (1 year 1 month)

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.

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Business Analyst

Atlas and Polar Airlines

Jun 2005 - Sep 2005 (4 months)

Responsible for using business analysis and analytics to make 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 JD Edwards ledger accounts. Recommended changes in
accrual process to improve accuracy in JD Edwards ledger accounts.

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Finance Manager

Alstom Transport Inc.

May 2004 - May 2005 (1 year 1 month)

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.

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Project Manager

Apr 2001 - May 2005 (4 years 2 months)

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.

Nicholas E Douglas

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Nicholas E Douglas

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Behavioral traits