Lance Wolf Email & Phone Number

Port St. Lucie, FL, US

Gaithersburg, Maryland, US

Senior Project Manager for Veeva modules including Quality Docs, Supplier Quality Management, Station Manager and Quality Risk Management. Additional projects include SAP Integrated Business Process, Waters Empower Upgrades, Sensitech Data Loggers, EviView Manufacturing Daily Management System and CISCO Digital Call Center.Senior Project Manager for.

Brentford, Middlesex, GB

Project Manager for Veeva Safety Vault program responsible for Regulatory and Operational reporting and Clinical Relationship Management Helpdesk (Salesforce) Interface workstreams.

New York, New York, US

Program Manager for Site Technology Experience Program (STEP) at major Pharma. Responsible for tracking and reporting progress for program designed to improve the clinical trial site staff experience with technology. Major accomplishments include increasing site use of the Shared Investigator Platform (SIP), Exostar Single Sign On enablement of core.

New York, New York, US

PM for pilot initiative utilizing SPARK ML/AI with internal and external data source integration to utilize Machine Learning and Artificial intelligence to identify potential “high performing” clinical research sites. Managed business and SPARK technical SMEs utilizing iterative development techniques to create and fine-tune algorithms identifying.

New York, New York, US

PM for new team implementing Oracle Select, a tool for data collection, review, and workflow for selection of sites for Clinical trials. Led Pfizer business and technical team through workshops, project planning, creation of required SDLC documentation, unit and end user testing, and implementation. Completed project within aggressive timespan of 5 months.

New York, New York, US

• Supported Business Project Leads for Data Collection and Data Review (DCDR), and CDISC standards programming in management of activities for Data Management and Clinical Operations process improvement initiatives.
• Created and maintained project plans, decision and action trackers, standing meeting and workshop agendas and meeting minutes, Sponsor, Steering Committee and PMO reporting materials.
• For DCDR supported four workstreams (Roles & Responsibilities, Playbooks, Data Optimization Review and Analysis Meeting Guidance, and Data Review Tools). Provided weekly status reporting to track progress and assisted.
• For CDISC Standards Programming team provided metrics and quad reporting for weekly PMO meetings, initiated monthly TA/Standards Programming Leads meetings to identify endpoints for priority STDM and ADaM development.

New York, New York, US

• Supported Business Project Leads in management of activities for integration of Quality Systems and Clinical Trial processes and procedures of acquired company. Assisted in completion of tasks within required timeframe.
• Created and maintained detailed Project Plan, Risk Register, Decisions and Actions tracker and tracked activities. Developed status reports for Core Team and Program Steering Committee meetings. Developed materials and.

New York, New York, US

• Supported three Business Process Owners in special projects, monthly reporting, and metrics tracking.
• Brought on by Data Quality organization to bring on track Data Quality Excellence initiatives which were behind schedule. Provide project management for business team struggling to complete objectives while dealing.
• Supported Data Quality Metrics, Data Quality Gates, and Clinical Study Document Review process projects. Developed agenda and materials for monthly reporting to Process Leadership Team and ran meetings when BPOs not.
• Recommending improvements to the Quality Gate process, resulting in elimination of low-value added activates and reducing QG cycle times. Worked with the Quality Gate Lead to document alternative process for studies.
• Managed completion of clinical study document review enhancements, including piloting of new processes and a new tool, Please Review, for in-house and external CRO study teams.

Somerset, NJ, US

• LIMS Project Manager. Consultant for the Global Laboratory Information Management system (GLIMS) project, based upon LabVantage Pharma, tasked with developing a global model and deploying to Catalent sites world-wide.
• Responsibilities include project management from charter to post go-live support, management and steering committee reporting to CIO and line SVPs, confirmation of project milestones and timelines, budget tracking and.
• Managed virtual team of internal Catalent IT and Business as well as external LabVantage team members from locations across the world.

• Project Manager consultant for Oracle Argus Safety implementation of a consolidated, world-wide, Drug Safety and Pharmacovigilance system for clinical study and post-marketed product event recording and regulatory.
• Responsibilities include all aspects of project management for mission critical program, from business requirements gathering, configuration, and customizations to post go-live break-fix and system enhancements.
• Focal point for cross-workstream project activities; interfacing with Training, Support, Infrastructure, Data Migration and Testing teams in support of overall program. Responsible for matrix-management of.
• Responsible for adherence to and completion of all GxP and Validation documentation per Merck SDLC SOPs.
• Successfully implemented Phase 1 of project and several post implementation enhancement releases.

• Manages all aspects of Medical Imaging Submissions (NDA/BLA) for leading Imaging Core Lab providing services to large, multi-national “top 10” pharma to small biotech companies. Responsible for creation and delivery of.
• Completed 16 client submissions projects. Eleven of which led to successful approvals.
• Developed and applied technology to create a validated data warehouse for reconciliation and reporting activities across three dissimilar systems. Results were improved data quality and faster turnaround time for.
• Championed brainstorming initiative to improve all aspects of submission data generation. Identified manual and automated process improvements, prioritized initiatives, delivered short, medium and long-term process.
• Liaise with FDA staff on submissions design, guidance questions and delivery of materials.
• Developed and delivered client presentations outlining company experience with regulatory requirements, imaging submissions process, key variables effecting overall project timelines

Bagsværd, DK

• Senior Manager of Projects and Process Services Managed 4 Project Managers and 2.5M+ budget for Project Management Office supporting information system projects for 1.5B Pharmaceutical organization. Mapped and.
• Demonstratively improved project resource estimating, tracking and reporting by implementing standard project estimating procedures ensuring scarce internal resources are fully utilized.
• Coached staff on project management issues, risks and obstacles. Successes include Sales and Marketing Compliance Training Tracking and Reporting system, Samples Inquiry Management system, implementation of Government.
• Managed project portfolio supporting business needs by developing and executing project and business technology strategy alignment plan.
• Ran meetings for Executive Steering Committee responsible for project governance. Reported on current project portfolio and upcoming project ideas.Project Manager (2/04-6/04)Responsible for Project Management for Sales.

• Project Manager (2001-2003)Responsible for developing and supporting systems for financial, contracts, chargebacks, and government and trade rebate programs.
• Improved reliability of Daily Sales system, an n-tier web-based EIS used daily by Vice-President of Finance to track sales. Managed support of system utilized to determine strategies to optimize sales.
• Managed support for Contract Management Reporting system, web-based reporting system used by Contracts group to track sales performance versus contractual terms, provide contract negotiation data and input to “Best.
• Managed test efforts for Compliance and Financial Systems impacted by mainframe outsourcing, project with estimated 2+ million yearly savings. Given cash award for contributions.
• Managed departmental efforts in support of Merck/Schering-Plough joint venture project of Vytorin product introduction. Achieved recognition award for on-time completion of tasks.Web Technology Project Manager.
• Chaired Web Technologies Task Force, setting priorities and working with divisional representatives to develop standards for Web tools such as content management and streaming video.

Master'S Degree, Management Information Systems, General

Education record