Ken Depasacreta Email & Phone Number

Yardley, Pennsylvania, United States

• Change Control and Project Management (Clinical and Quality Vaults)
• Translate business needs into technical requirements and configurations to implement change requests efficiently and effectively
• Liaise with business owners, system administrators, and technical professionals globally to determine feasibility of requested changes and meet the users’ needs
• Conduct change control process from request to implementation utilizing GxP practices
• Develop Operational Performance Qualification scripts and act as test lead to formally execute scripts
• Actively contribute as a member of the validation team to optimize the change control process Develop future state process models for global pharmaceutical companies

New Hampshire, United States

The Associate Director, Project & Program Management is responsible for the leadership and delivery of large or complex client projects and portfolios to support clinical, regulatory, and business users. Ensure the on-time delivery of projects and programs within agreed budgets and deliverables, resulting in high client satisfaction. Skillfully identified.

New Hampshire, United States

The Manager, Service Transition works as an integral part of Service Management to support business engagement with the client throughout the relationship lifecycle. Developed project management capability utilizing ITIL methodologies. Directed client-centric Service Transition Managers who lead execution of service implementation projects. Executed new.

Billerica, MA

The Manager, Service Transition works as an integral part of Service Management and helps to support business engagement with the client throughout the relationship lifecycle. The role develops Project Management capability in Technology Run Services (TRS) and directs client-centric Service Transition Managers who lead execution of service implementation.

Billerica, MA

Provide tactical management, administration, and leadership to project teams on highly complex upgrade projects. Directed the coordination of multidisciplinary global project teams to deliver technology and operational projects related to upgrade of 15 client EDC platforms and implementations of 200 trials of varying size and complexity. Succeeded in.

Cambridge, MA

Responsible for Leading the evaluation of new clinical technologies and management of hosted development and production environments in support of clinical data capture and analysis. Managed clinical data systems used in clinical studies and provided programming and technical support for Data Management and Clinical Operations. Managed a team of 3 clinical.

Burlington, MA

Project ManagementResponsible for the technical and business quality of engagement work products, solutions, and deliverables. Assure process compliance with all regulatory and Phase Forward procedural requirements. Organize, direct, and coordinate planning and implementation of all contracted project activities. Develop project plans, tasks, deliverables.

Lead, communicate, motivate and organize district units in a successful popcorn sale. Working with the unit committee: Decides the quantity of popcorn needed to be sold to fund unit’s annual budget. Decides on quantity of a Show-N-Sell popcorn to order. Decides on unit incentives to encourage Scouts: Top Seller Award, Top Den/Patrol Award, local businesses.

Project ManagementResponsible for the technical and business quality of engagement work products, solutions, and deliverables. Assure process compliance with all regulatory and Phase Forward procedural requirements. Organize, direct, and coordinate planning and implementation of all contracted project activities. Develop project plans, tasks, deliverables.

• OPERATIONS
• Address evolving customer needs for, performance requirements, and procedural or application solutions. Execute new procedures to advance design methodologies. Spearhead testing methodologies.
• Manage day-to-day clinical specification priorities. Develop procedures and documentation standards. Construct flexible staffing and resource allocation methods.
• Hire and manage the clinical team. Design and assure appropriate staffing to address high volume turnaround, continuity and skill coverage needs. Provide technical leadership to the group.CUSTOMER SERVICE
• Work with project managers to plan resources and set-up timelines for customer projects. Execute to assure customer specified deliverables are met.
• Execute rapid response to customer application contingencies.

Lead the project team through the design, development and implementation of Electronic Data Capture (EDC) clinical databases using third party development tools and C#, VB Script, XML, and ASP.net. In adherence to company SOP’s, Work Instructions, and SDLC, author, review and approve software requirements, develop eCRF’s, coding of edit checks and.

• Project Lead and Lead Develop for 7 Clinical Study Databases insupport of PMA submission for an innovated medical device- SQL Server 2000, VB6, MS Access 2000 Authored SRS’s and SDD’s in adherence with company SOP’s..

• SeroCare - MS Access 95/97Project DescriptionTracking of insurance provider acceptance and/or rejection of a new drug for the Metabolic and Immune Therapy SBU. Program tracked a case-by-case detailed history of the.
• ClinTrak - MS Access 95/97Project DescriptionCo-authored ClinTrak, a clinical tracking database system, used to capture, organize, and store critical information in support of the endocrinology Strategic Business.
• Marketing Expense Tracking (MET) System - MS Access 95/97Project DescriptionDesigned Marketing Expense Tracking (MET) system to increase efficiency in tracking, analyzing, and reporting of budget data.

Theatre/Theater

Theatre/Theater

Activities and Societies: Exchange student through Marymount College

Software Development

Activities and Societies: - Microsoft Certified Programming with C# - Microsoft Certified SQL Server Administration - Microsoft Certified.