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 • Analyze existing and future state business processes and workflows • Create future state business processes and workflows as well as materials supporting optimized processes • Author and update Standard Operating Procedures as they pertain to new processes being implemented

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, assessed, and managed risks to the project's success and overall scope. Planning, directing, and coordinating of activities to manage and implement programs from contract/proposal initiation to final operational stages. Over the smooth transition into the "business-as-usual" phase, ensuring seamless operations and client satisfaction. Established and lead focused client delivery teams, bringing together 12-15 smaller biotech portfolios and 40-50 trials. Through dedicated project management concentration, aligned efforts across multiple therapeutic areas, resulting in enhanced efficiency and effectiveness. Fostered strong relationships with internal and external vendors and clients, effectively managing licenses, proposals, work orders, and executive-level reporting. Demonstrated exceptional communication and negotiation skills to maintain successful partnerships.

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 Service Transition process with accountability to support P&L owners to deliver the budgeted revenue and gross margin expected from client accounts. Quality management of service transition projects with the result of reducing costs of implementation and ongoing maintenance by 10% while increasing customer satisfaction by 30%.

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 projects in TRS. The role owns execution of Service Transition process in PI and it has accountability to support P&L owners to deliver the budgeted revenue and gross margin expected from the various client accounts by providing quality management of service transition projects to TRS with the goal to minimize costs of implementation and ongoing maintenance but maximize customer satisfaction. In addition, the Manager, Service Transition will look to ensure that they and their team create the solid foundation for incremental and additional business in all of the supported accounts.

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 roll-out of eClinical systems including EDC, TMF, third-party integrations, and user management tools from planning to post-deployment to enable a diverse development and hosted environment for trial lifecycle management across cross-functional teams.

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 designers and clinical programmers to support data management in EDC trial deployment. Managed projects from definition to validation and delivery following relevant regulatory and Quality Management systems. Authored SOPs and work practices in support of overall eClinical program.

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, dependencies and resource requirements. Track and communicate project status, plans, issues, timelines, action items, and budgets.Exercise scope management/control respecting the client, team, and Phase Forward needs; Develop contingency plans. Assure process compliance with all regulatory and Phase Forward procedural requirements.Team ManagementManage multi-discipline teams of internal & external resources. Interact and communicate regularly with team and client staff. Mentor team members on project techniques, communication methods. Understand project skill requirements; define team roles and responsibilities; assemble resources. Oversee work and mentor junior staff members on development team. Interact and communicate regularly with team and client staff; Document weekly status reports.Application DesignManage delivery of new clinical trial processes within a customer consultative relationship. Assure that the work product and project deliverables are of the highest quality to satisfy client expectations. Assemble Quality System Plan documents and records. Conduct quality assurance and acceptance testing—verify quality of InForm application installation.Process DesignIdentify opportunities for process improvements. Assess, recommend, and implement recommendations.Lead Process Improvement Teams. Create new project processes and methods. ntroduce processes to organization. Develop instructions and materials. Develop and implement tracking methods and quality metrics. Provide leadership to the group. Provide formal or 1:1 training to staff.

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 donations, free camping trips, etc. Ensures key popcorn dates are on unit’s calendar. Schedules and promotes a Unit Popcorn Kickoff.

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, dependencies and resource requirements. Track and communicate project status, plans, issues, timelines, action items, and budgets.Exercise scope management/control respecting the client, team, and Phase Forward needs; Develop contingency plans. Assure process compliance with all regulatory and Phase Forward procedural requirements.Team ManagementManage multi-discipline teams of internal & external resources. Interact and communicate regularly with team and client staff. Mentor team members on project techniques, communication methods. Understand project skill requirements; define team roles and responsibilities; assemble resources. Oversee work and mentor junior staff members on development team. Interact and communicate regularly with team and client staff; Document weekly status reports.Application DesignManage delivery of new clinical trial processes within a customer consultative relationship. Assure that the work product and project deliverables are of the highest quality to satisfy client expectations. Assemble Quality System Plan documents and records. Conduct quality assurance and acceptance testing—verify quality of InForm application installation.Process DesignIdentify opportunities for process improvements. Assess, recommend, and implement recommendations.Lead Process Improvement Teams. Create new project processes and methods. ntroduce processes to organization. Develop instructions and materials. Develop and implement tracking methods and quality metrics. Provide leadership to the group. Provide formal or 1:1 training to staff.

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.• Manage customer dialogs for acknowledgement, ownership, commitment, and follow-through.MANAGEMENT REPORTING• Develop operational reports to demonstrate and document operational quality.

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 validation rules, design SAS export sets, and generate study specific reports and listings as needed.

•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. Used Quality System Requirements (QSR) development standards in CFR Part 21 and provided all documentation to Software Quality Control group for database validation. Developed and implemented unit tests and validation/verification test plans for software releases by regulated change control system. Collaborated with Clinical Group and third party Statistical CRO to develop Data Management Plan, data integrity checks and data analysis plan. Managed migration of all clinical data activities to SQL Server from Access for both greater reliability and regulatory required audit trail capabilities. Provided for secure electronic transfer (via Secure FTP) from external CRO’s to in-house databases.

• 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 patients’ care and insurance coverage to report to management. • 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 Unit’s compassionate use, clinical trials. It is a comprehensive tool designed to track all of the required forms and documents for a study site. It also tracked patient progress throughout the study so status reports could be created and presented.• 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.