Chris Lemaire's Location
Escondido, California, United States, United States
Chris Lemaire's Contact Details
Chris Lemaire work email
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About Chris Lemaire
Seasoned Clinical Data Manager. Extensive experience leading cross functional study teams as a Principal Clinical Data Manager, Manager Clinical Data Management, Clinical Programmer and Biostatistical Programmer. Extensive expertise in all facets of study initiation, study conduct , database lock, regulatory compliance, vendor management and process improvement. Leverages technical experience with strong communication skills, working well with a wide range of business contacts. A reliable producer who oversees projects from beginning to end, ensuring high quality data management.
Chris Lemaire's Current Company Details
Stemline Clinical Data Management Consultant (August 2020 – December 2021) Green
Senior Clinical Data Manager
Encinitas, CA, US
Chris Lemaire Work Experience Details
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Senior Clinical Data ManagerStemline Clinical Data Management Consultant (August 2020 – December 2021) GreenEncinitas, Ca, Us
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Senior Clinical Data ManagerStemline Clinical Data Management Consultant (August 2020 – December 2021) Green Key Resources Aug 2020 - Present• Performed Study Initiation and Conduct activities for a Phase I study using Medidata Rave• Oversight of Phase 1 Clinical Study during study initiation and conduct.• Updated edit checks that were not working properly.• Updated Data Transfer Agreements with study vendors.• Wrote Data Management Plan for Phase 1 study.• Provided updates for DSUR.• Created Patient Profiles for Medical Review.• Performed MedDRA and WHO Drug coding in Rave.
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Data Team LeadIqvia Feb 2018 - Feb 2020IQVIAData Team Lead (May 2019 – February 2020)• DTL for large Phase IIB Oncology rescue study.• Implemented 70 data listings for data cleaning activities.• Implemented 145 Rave edit checks for data cleaning activities.• Performed data cleaning, and database lock and data transfers for DSURs and Interim Analysis.• Updated archived vendor specific Data transfer Specifications.• Maintained Data Management SOP training archive.• Conducted weekly Data Management Team Meetings.• Provided updates of study related metrics to management.
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Sr. Clinical Data ManagerDart Neuroscience Llc Feb 2016 - Feb 2018• Performed Study Initiation and Conduct activities for two Phase I studies using Medidata Rave• Oversight of CROs during study initiation, conduct and lock of four clinical studies.• Wrote Study Initiation and Database Lock SOPs.• Provided updates for Annual Reports and Investigator Brochure.• Performed final QC of SDTM datasets.• Performed QC of final Tables, Listings and Figures for Clinical Studies.
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Clinical Data Management ConsultantAlzhiemer'S Diease Cooperative Study - Ucsd Aug 2015 - Dec 2015• Clinical Data Management Consultant supporting Toyama T-817MA (TCAD) clinical study.• Finalized Data Validation Specifications.• Performed UAT of Data Validation Specifications.• Finalized Protocol Deviation Specifications.• Performed UAT of Protocol Deviation Specifications.• Wrote Data Management Plan.• Provide status reports reflecting query resolution rate, open queries, missing eCRFs, percent of eCRFs SDV’d, cleaned, locked and listing of open queries.• Provide status reports reflecting projected Last Scheduled Visit for all subjects grouped by site.
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Clinical Data Management ConsultantConatus Pharmaceuticals Feb 2015 - Aug 2015• Oversight of CROs during conduct of three clinical studies.• Provide status reports reflecting query resolution rate, open queries, missing eCRFs, percent of eCRFs SDV’d, cleaned, locked and listing of open queries.• Worked with study monitors to ensure eCRFs were properly completed.• Managed changes to eCRFs and EDC database.• Assembled lab safety data from nine legacy studies for Integrated Safety Analysis into SAS datasets in SDTM format.• Provided change from baseline labs safety reports using SAS for the Medical Safety Monitor.• Provided ad-hoc reports at the request of the Chief Scientific Officer for use in decisions for the study design for future Phase II and III studies.• Reconciled TMF for GCP audit of eight clinical studies ensuring key documents were accounted for and present in the document control system.• Authored four SOPs: Data Management Study Initiation, Data Management Study Conduct, Data Management Database Lock and Study Close-out and Clinical SAS programming.
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Principal Clinical Data ManagerAllergan, Inc Feb 2006 - Nov 2014Allergan Medical Dermatology and Device Therapeutic Area: Lead Data Manager Responsible for the Initiation, Conduct and Database Lock of Phase IV post marketing studies. Initiated the S17L-001 JUVEDERM VOLIFT and the VOBELLA-004 JUVERDERM VOLBELLA studies. Responsible for the Database Lock of a critical post-marketing study (ADJUNCT) that contained over eighty-four thousand subjects. Study Initiation Group: Extensive experience leading the initiation phase of clinical studies. Lead Data Manager for the initiation phase of the 214868-004 Overactive Bladder and Urinary Incontinence study using the Phase Forward Inform Clinical Data Management System. This study completed database setup activities 12 days prior to First Patient Enrolled. Study Data Manager for the Allergan Medical Therapeutic Area. Received an Allergan Award for Excellence for creating/implementing the Edit Check Specifications for 3 studies adapting the Allergan Edit Check Template when the data management activities transferred from the Santa Barbara to Irvine offices. Neurology New Technology Therapeutic Area: Lead Data Manager Responsible for the Initiation, Conduct and Database Lock of 5 critical Phase I-II studies. Additionally, Lead Data Manager for 5 outsourced studies through the database conduct and database lock phases. Participated in the mock audit of a clinical study that resulted in stellar evaluation of the Data Management and Programming group. Was lead author for the Electronic Data Management Plan template.
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Manager Data ManagementSantarus, Inc. Oct 2001 - Dec 2005Data Management: Started the Clinical Data Management department and implemented the Clinical Database Management Information System (DataFax). Member of a cross functional team that gained approval of Santarus’ initial drug candidate Zegrid. Responsibilities:• The design, validation, support and implementation of clinical databases for phase I-IV clinical studies from project inception to project completion.• Wrote Standard Operating Procedures (SOPs) and Work Instructions (WIs) used to manage the flow of information through the data management department. • Designed Case Report Forms (CRFs) and setup the clinical databases. • Wrote Data Management Plans for clinical studies.• Developed Data Validation Specifications and programmed automatic data checks.• Programmed summary listings in SAS used to monitor and clean clinical databases. • Programmed database extractions from DataFax to SAS.• Acted as a liaison representing the Data Management department during interactions with Biostatistics, Clinical, Legal, Accounting and Information Technology departments. • Worked closely with software vendors and Contract Research Organizations (CROs). • Trained study coordinators on how to complete CRFs during investigator meetings. • Hired, trained and supervised data entry staff. -
Manager Data ManagementLa Jolla Pharmaceutical Apr 2000 - Oct 2001Data Management: Started the Clinical Data Management department and implemented DataFax, the Clinical Database Management Information System.Responsibilities:• All data management activities for phase I-III clinical studies. • Interacted closely with Biostatistics, Programming, Clinical Operations and Medical Affairs staff. • Designed CRFs from clinical protocols used to record data during clinical studies. • Developed data management plans for clinical studies. • Responsible for designing, testing, validating and documenting clinical databases prior to production release. • Developed and wrote Standard Operating Procedures (SOPs). • Developed Data Validation Specifications. • Programmed automatic data validation checks and summary tables and listings in SAS.
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Clinical Database Manager And Biostatistical ProgrammerParexel International Aug 1997 - Apr 2000Data Management and Biostatics: Extensive experience as a Clinical and Biostatistical Programmer and Data Management and Programming team leader.Responsibilities:• Designed and setup clinical databases using Clintrial 3.2 for phase I – III studies in a variety of therapeutic areas. • Reviewed CRF design. • Programmed automatic data checks in SAS. • Programmed statistical tables and listings in SAS using the Statistical Analysis Plan as a guideline. • Validated SAS programs to ensure that the correct results are produced. • Worked closely with Clinical, Medical, Project Management and Biostatistics departments to ensure project timelines and client deliverables were completed on-time and within budget.
Chris Lemaire Skills
Clinical Trials
Clinical Data Management
Pharmaceutical Industry
Data Management
Sop
Clinical Development
Cro
Edc
Clinical Research
Ctms
21 Cfr Part 11
Biotechnology
Validation
Gcp
Good Clinical Practice
Ich Gcp
Clinical Trial Management System
Electronic Data Capture
Chris Lemaire Education Details
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San Diego State UniversityInformation Systems / Business Administration -
Danny Phung
Frequently Asked Questions about Chris Lemaire
What company does Chris Lemaire work for?
Chris Lemaire works for Stemline Clinical Data Management Consultant (August 2020 – December 2021) Green
What is Chris Lemaire's role at the current company?
Chris Lemaire's current role is Senior Clinical Data Manager.
What is Chris Lemaire's email address?
Chris Lemaire's email address is le****@****gan.com
What is Chris Lemaire's direct phone number?
Chris Lemaire's direct phone number is +176040*****
What schools did Chris Lemaire attend?
Chris Lemaire attended San Diego State University, Danny Phung.
What skills is Chris Lemaire known for?
Chris Lemaire has skills like Clinical Trials, Clinical Data Management, Pharmaceutical Industry, Data Management, Sop, Clinical Development, Cro, Edc, Clinical Research, Ctms, 21 Cfr Part 11, Biotechnology.
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