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Project Manager Clinical Research

Concord, MA
October 11, 2018

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Sheldon K. Hines

** *** ****** ****, *******, MA 01742

Mobile phone: 617-***-**** Home phone: 978-***-****



Position that utilizes my skills in Information Technology, Consulting, Project Management, Systems Analysis, Data Management, Customer Care and Business Analysis as well as my extensive experience working for Pharmaceutical, Clinical Research and Software companies


Quality-focused customer care manager, project manager and systems analyst, with strong communication skills and more than 30 years of experience in IT services. More than 14 years of experience in customer care, project management and data management for IT support of clinical trials, using Electronic Data Capture (EDC) and electronic Clinical Outcomes Assessment (eCOA/ePRO) systems. More than seven years of experience in implementation services, business analysis and customer training for large scale financial systems in a variety of industries.

Career History

January 2015 to present: Consultant

Provided consulting services (January – October 2015) for MProve Health, a vendor of eCOA software used in clinical trials, including:

1) Analysing an early release of the client’s software for data collection with respect to usability and ability to capture clinical data accurately

2) Providing answers to selected questions in an RFP regarding client’s responsibilities and processes for managing data collection using the client’s software

3) Providing a checklist of features and functions of a data collection system such as the client’s that would be required to comply with FDA regulations and guidance.

Provided information to a Research firm about the market for eCOA and eConsent software (March 2018).

Built a web site using WordPress for The EMR Network (March 2018).

November 2014 to May 2015: Project Manager

Researched feasibility of use of bring-your-own-device (BYOD) concept for use in collecting data directly from subjects in clinical trials (eCOA/ePRO), for a consortium of service providers – MProve Health, Medidata Solutions and ICON Clinical Research..

April 2012 to August 2014: Senior Project Manager

ICON Clinical Research (US-based)

Worked at home (16 months) and in the Durham NC office of ICON (11 months).

Managed technical and administrative aspects of multiple, simultaneous, complex projects.

Projects included oversight of delivery of eCOA services and devices for clinical trials by CRF Health, Bracket, and ERT and messaging system services by Exco InTouch.

Vendor oversight tasks included: review and commenting on eCOA aspects of the draft study protocol, eliciting additional system requirements from the sponsor, review and approval of system specifications, management of and participation in execution of User Acceptance Testing, participation in weekly vendor status meetings and participation in weekly study team meetings.

Provided regular financial reports to management on my projects.

Participated in an audit of one of my projects and used ICON’s Quality Management System to document and respond to CAPAs.

Used Change Control Systems to document User Acceptance Test findings and document their resolution.

Approved invoices from subcontractors for payment.

Actively participated in ICON management activities and initiatives, including improvement of SOPs and process documents, creating templates for deliverables and developing organizational structure of filing of project documentation.

Made sure that all project documentation was filed correctly and ready at all times for audit.

Negotiated and made final edits on the Master Service Agreement between a key eCOA vendor and ICON.

January 2008 to April 2012: Technology Project Manager

Chiltern International (US-based)

Assigned to Pfizer Inc. and stationed in Cambridge, Massachusetts. Internal job title at customer was Sr. Patient Technology Manager. Responsible for supporting global use of advanced technologies for electronic data capture of eCOA in clinical trials.

Developed policy, business processes, and tools for usage of eCOA by clinical study teams.

Took ownership of projects, engaging a variety of stakeholders and customer groups to make sure study teams were enabled to implement eCOA in clinical studies.

Served as Data Management expert in eCOA on specific clinical trials, by providing advice on implementation of eCOA, reviewing and commenting on vendor deliverables, and enforcing Pfizer standards imposed on vendors.

Contributed to and drove initiatives to standardize the process of implementing and maintaining eCOA systems across the customer’s vendor panel.

Provided oversight of the performance of vendors and organized remediation efforts for vendor deliverables or processes that did not meet Pfizer standards.

Researched allied technologies and assisted in forming a future vision for Pfizer’s eCOA usage.

Interacted with Pfizer Business Units to identify specific needs for eCOA support.

Developed Guidelines & Templates for conducting User Acceptance Testing (UAT) of eCOA and performed UAT based on such guidelines.

Developed expectations for vendors in generating inspection-ready archives of eCOA data and documentation and reviewed vendors’ archive for compliance with them.

Developed guidance to authors of Pfizer clinical protocols on including information about eCOA in their protocols.

Drafted a response to the European Medicines Agency’s Reflection Paper on eSource.

From December 2007 to January 2008: Senior Consultant

ASG, Inc (Cary, NC)

Consultant to Regeneron Pharmaceuticals in Tarrytown, NY on a short-term basis.

Re-designed the key electronic case report forms (eCRFs) for a clinical trial (Ophthalmology). This change reduced time to completion of data entry from 2 minutes to 10 seconds for key eCRFs in their InForm EDC system.

Prepared User Acceptance Test (UAT) plans, data and expected results for the edit checks on updated eCRFs in the EDC system for the trial, and led the successful UAT effort.

Advised customer on strategy for facilitating communications with a vendor used in the trial.

June 2000 to October 2007: Principal Project Manager

Phase Forward Incorporated (Waltham, MA)

(now a division of Oracle Corporation)

In the Services Division of this leading vendor of EDC and Safety software, served as a senior project manager for customers in the Pharmaceutical, Biotech, Medical Device and Medical Research industries, including Pfizer, Duke University, Biogen Idec, and Alexion Pharmaceuticals.

Provided account management including: client communications; project management for automation of data entry (EDC and eCOA) and data management of clinical trials for drugs, biologics and medical devices; compliance with Good Clinical Practice, Standard Operating Procedures and US FDA regulations; design and configuration of electronic case report forms, automatic queries, custom reports, IVRS interfaces, and clinical databases; quality assurance of the configured EDC system; hosting EDC systems on servers at secure data centers; and planning and implementation of technology transfer to customers.

Managed development, maintenance and lock phases of EDC systems for more than 20 clinical trials for 10 customers, across Phases II, III and IV.

PM for Electronic Data Capture (EDC) systems of pivotal clinical trials for two Biotech customers whose substances received FDA approval on my watch.

Identified process enhancements and helped to implement them.

Worked with Sales to prepare work orders and make successful bid defence presentations to customers.

Responsible for as many as twelve EDC projects for four customers at one time.

Responsible for work of multiple development and maintenance teams.

1994 to 2000: Practice Manager

Walker Interactive Systems (Boston, MA)

Provided project management, systems analysis and training services for customers of a software company that provided high-end, mainframe-based financial software.

Performed services for multiple large customers, including American Express, United Airlines, Delta Airlines, Food Lion, Amtrak, Thailand’s national electrical generation system, Indonesia’s second largest oil exploration company, and a large electrical utility in the north eastern US.

Managed an internal project to develop repository of knowledge base, methodology and templates for use by Walker consultants in professional services projects.

Used Microsoft Project to create and manage project plans.

Specialized in Accounts Receivable, Billing, General Ledger and Project Cost Management software.

Used IBM mainframe (Walker's Tamaris line), server platforms (Essbase) and PCs (Walker’s GUI and FOCUS for Windows) to meet customer needs.

Provided business process reengineering and developed specifications for customizing delivered transactions, databases and interfaces.

Travelled 50% or more.

Trained customers and new Walker employees in the Tamaris AR and GL modules.

Developed methodology and templates for customizing various software modules.

Determined general needs of prospects and wrote successful proposals.

Provided implementation, migration and operational management services.

1993 to 1994: Project Coordinator

MA Turnpike Authority (Boston, MA)

Provided project coordination and systems analysis services in the IT Department of the state authority that managed and maintained the principal toll road and tunnel system in Massachusetts.

Coordinated purchase and implementation of a financial information system based on Oracle Financials and the Oracle RDBMS.

Drafted the contract with the successful bidder – Digital Equipment Corporation – for hardware, system software, relational database and financial software package.

Played significant role in implementing the Oracle Financials General Ledger module, including design of the accounting control key and chart of accounts.

Supervised as many as five MTA personnel.

1992: Independent Consultant

Key areas of Responsibility:

For Massachusetts Turnpike Authority, provided systems analysis and planning to prepare for purchase and implementation of a new financial software package.

For Coopers & Lybrand, evaluated test results, prepared plans for system testing, and identified improved methods of testing for a project to develop a large financial management system on an IBM mainframe.

1983 to 1991: Final Position: Managing Associate

Coopers & Lybrand (Boston, MA / Wash., DC)

Served as Managing Associate (1989-91), Supervising Consultant (1985-88) and Consultant (1983-84) in the IT Management Consulting Department.

Sold and managed multiple information system consulting projects. Example: a project for Pine Street Inn, a large, not-for-profit, homeless shelter.

Provided information technology planning services. Example: supervising consultant on a large project for the NY State Department of Transportation.

Defined requirements, developed technical design specifications and performed systems testing. Example: supervising consultant for development of the Official Mail Billing System for the US Postal Service, designed to handle billions of dollars of billings to the Federal agencies.

Reviewed and recommended enhancements to information systems, such as for Unitrode Corp., an electronics manufacturer.

Managed a sensitive project to document and reengineer procedures for control of financial information and documents at a large NE bank.

1978 to 1983: Consultant

Coopers & Lybrand (Washington, DC)

Served as a consultant in the Economics Studies unit of the Management Consulting Department.

For US Postal Service, supervised researchers, performed economic and marketing analysis, and wrote much of the 800-page report of the Study on Competition and Demand.

For the US Selective Service System, assisted in logistical planning for the reintroduction of draft registration and performed computer simulation of the rate of induction of draftees in case of mobilization of US armed forces.

Managed a 10-person team of accountants to reconcile contracts for the US Defense Logistics Agency.


Co-author of Zbrozek A, Hebert J, Gogates G, et al. Validation of electronic systems to collect patient-reported outcome (PRO) data - Recommendations for clinical trial teams: Report of the ISPOR ePRO systems validation good research practices task force. Value Health 2013:16:480-9

Qualifications & Training

Bachelor of Arts (History) Yale University

M.A. (International Affairs) George Washington University

Other Graduate University Courses: Accounting, Economics, and Statistics

Other Training:

Structured Systems Analysis, Report Generation (FOCUS), System Testing, Phase Forward’s InForm software (for electronic data capture and data management of clinical trials over the Internet), Phase Forward’s Clintrial software (for data capture and data management of clinical trials), Safety in Clinical Trials.

Extensive training in Good Clinical Practice (GCP) and as well as the regulations and guidelines of the US FDA relevant to clinical trials and use of electronic systems to support clinical trials.

Extensive training in SOPs and Business Process Documentation of Pfizer Inc. and ICON Clinical Research.

Additional Skills

Experience in quality control of vendor deliverables and UAT of eCOA systems provided by CRF, PHT and ERT.

Trackwise, MS Project, Excel, Word, PowerPoint, Visio.

Intermediate-level conversational, reading and writing ability in French language.

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