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 regulatory requirements• 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 are accurate, complete and in consistent formats conducive to analysis and possible regulatory submissions• 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, snapshots, database locks, etc.)• Review protocols to ensure data collection and database feasibility• Coordinate EDC training at Investigators' meetings and for other internal and external project members as needed• Oversee the design and implementation of CDM reporting (data completeness (e.g. lag), monitoring progress, queries outstanding, query aging, etc.), biological sample reconciliation, coding and SAE reconciliation• Define and implement documentation and archival standards for Clinical Data Management to ensure CDM project documentation is in an audit-ready state• Manage vendor oversight of study-specific files and accurate supporting documentation to enable the reconstruction and evaluation of data management conduct in a clinical trial

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 as an operational expert in data flow and study execution by all functions across Development Sciences.• 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 appropriate risk mitigation as needed.• 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.• Accountable for overall quality of study/program data. Develop risk mitigation or action plans and oversee execution when appropriate.• Primary contact between CDS and clinical study management teams (SMT and/or Clinical Development Team representatives). Liaise directly with internal customers (CDS functions, GCO, Biostatistics, Regulatory Affairs) and external customers (Full Service and Functional Service Provider Data Leads and Project Management personnel) • Subject Matter Expert for data, reporting, and analysis process definition, improvement, and innovation as needed.

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, III and IV.• 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.• Facilitate communication, meetings and issues between Clinical, CDM Management, Biostatistics, Lab Systems Administration, CDM Systems and vendor staff.• Ensure that study timelines are met.• Participate in process improvement initiatives relating to CDM

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 and IV.• 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.• Write queries for data inconsistencies and revised database and Case Report Forms in compliance with Standard Operating Procedures, Client guidelines, Regulatory Agency guidelines and Good Clinical Practices.

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.