Greg Lippert Email & Phone Number

Pasadena, California, US

Pasadena, California, US

• Provide CDM operational leadership to the direction, design, planning, execution, collection and handling of all clinical data to the highest quality standards in accordance with GCP, GCMP, internal SOPs and all.
• Identify suitable vendor(s) for outsourcing data management activities and coordinate the review and approval of contracts, VSW's, DTP's and any relevant documentation.
• Responsible for development, maintenance and governance of CDM global, harmonized SOPs, Business Practices, Oversight Plans and specific quality processes and procedures for Data Management.
• Create Global Library and develop Xencor CDM Standard (eCRFs, database interfaces, edit checks, supporting specifications, documentation and external data files, CDASH, CDISC, SDTM) in order to produce datasets that.
• Responsible for building effective CDM vendor relationships to ensure the quality and timeliness of clinical data milestones and deliverables (Study-start up procedures, database development, DMP development.
• Review protocols to ensure data collection and database feasibility

Pasadena, California, US

Pasadena, California, US

Cambridge, MA, US

• Manage the end to end clinical data flow (data acquisition from Case Report Form (CRF) to Clinical Study Reporting (CSR) to Electronic Submission (ESUB) of Clinical Data) and ensure timely project execution; recognized.
• Partner with CDS Data Strategy Lead and key study/program team members to co-author and ensure execution of a robust and clear Data Strategy for each study and/or Program.
• Oversee CROs and other vendors to ensure timely execution on large and/or highly complex projects. Manage performance and quality issues with vendors and escalate to vendor managers and Management and develop.
• Develop study/program level quality plans and ensure adherence and consistent execution across the data flow.
• Consult with key study/program team members to drive improvement and solutions across multiple studies within a program.
• Interpret and apply data strategy, verify consistency and usage of data, results and submissions standards, coordinate and oversee outsourced personnel, and monitor and reports on overall study/program progress.

Thousand Oaks, CA, US

• Senior Associate, Clinical Data Management, U.S. Clinical DevelopmentManage all Data Management activities and resources for Cardiology, Oncology, Inflammation and Early Development Clinical Trials, Phases 0, I, II.
• Direct study and program level management of CRO, FSP and internal CDM staff including CDM Systems, Operations, Lab Systems Administration, Edit Check Programming, SAS-EDI, Data Review staff.
• Represent CDM on assigned study teams including attendance and/or presenting at CDM Staff, Dose-Level review, Investigator and CSM meetings.
• Develop and maintain study documentation including Data Management, Communication and Data Transfer Plans with internal and external vendors.
• Facilitate eCRF creation, database builds, SAE Reconciliation, Data Review functions, Line Listing Review and Important Protocol Deviation assignments.
• Review all documents for assigned studies including Protocols and Amendments, eCRF’s, Data Transfer Plans, Communication Plans, Scopes of Work, Vendor Charters, QC Plans, timelines and Study Reports.

Thousand Oaks, CA, US

• Clinical Data Associate II, U.S. Medical Affairs Biostatistics (contractor) 2004-2005 Supervise all Data Management functions and up to three staff members for Oncology and Nephrology Clinical Trials, Phases II, IIIb.
• Facilitate Data Acceptance procedures including writing and validating Data Acceptance checks, reporting findings, resolving data issues, and validating Protocol Deviations.
• Review all documents for assigned studies including Protocols and Amendments, Case Report Forms, CRT Specs, Data Edit Specs, QC Plans, timelines and Reports.
• Facilitate communications, meetings and issues between Clinical, Data Management, Biostatistics, Statistical Programming and CRO staff.
• Communicate and implement process improvements.

• Perform all Data Management functions for Clinical Trials, Phases I, II and III.
• Coordinate the Data Management process on assigned projects in compliance with Standard Operating Procedures, Client guidelines, Regulatory Agency guidelines and study benchmarks.
• Review Study Protocols and incorporated Protocol specific guidelines into the Case Report Form design, Study Setup Details, Data Management Plans, Laboratory Data Transfer Agreements and Clinical Trial data.
• Develop and maintain study documentation including project files, Data Management Plans, Study Specific Details, and project correspondence.
• Develop, test and maintain Clinical Trial databases, Data Entry Screens, Tracking databases, and data transfers.
• Develop and implement Data Validation Procedures including programming, testing and maintenance of edit checks and manual CRF and listings review.

Durham, North Carolina, US

• Participate in Data Management study start-up procedures through review and implementation of study Protocols, SOP’s, Client regulatory guidelines and Good Clinical Practices.
• Insure data accuracy through discrepancy review and management, query review and integration including Laboratory, Medical Review, Coding and SAE queries, and through manual CRF and data listings review.
• Facilitate resolution of data issues between Data Management, Clinical, Regulatory, Biostatistics and Project Management personnel.

• Manage CRF flow through tracking Case Report Forms, Data Transmittal Forms, Laboratory and special procedure Reports, and Data Clarification Forms.
• Perform first and second pass data entry functions.
• File study documentation including Case Report Forms, Laboratory reports, queries and Site record forms.
• Participate in Data Validation through query management, CRF and data listing audits.