Marguerite Beplat
New London,CT
Summary
Dynamic Senior Clinical Data Manager with extensive experience at top leading CROs, excelling in clinical data management execution and implementation. 20+ years in Clinical Data Management with over 7 years as Lead DM. Proven track record in developing comprehensive data management documentation and fostering excellent cross-functional team relationships through intentional communication. Highly skilled in Medidata Rave EDC with over 9 years of experience. Committed to ensuring timely, high-quality deliverables, audit readiness, and excellent internal and external client relationships. Emphasis on knowledge-sharing, ownership and accountability, and mentoring or junior associates.
Overview
26
26
years of professional experience
1
1
Certification
Work History
Senior Clinical Data Manager
Caidya
Raleigh, USA
03.2020 - Current
- Lead clinical data management activities for projects, including CRF design, database development, vendor data processing and reconciliation, data review, user acceptance testing, and data cleaning.
- Oversee SAE reconciliation and local lab module management, ensuring compliance with ICH Guidelines, Good Clinical Practice, and company Standard Operating Procedures.
- Act as the primary contact for study database start-up, maintenance, close-out, and database lock activities.
- Foster strong relationships and communication with sponsors and internal teams while managing study timelines, budgets, quality, and task delegation for local and global team members.
- Develop essential study documentation, including the Data Management Plan, eCRF Completion Guidelines, Data Validation Plan, and QC Plan, while maintaining version control and tracking updates.
- Provide mentorship and training to new team members on study tasks, processes, and documentation development.
Clinical Data Lead
ICON
Pennsylvania, USA
04.2019 - 02.2020
- Served as the main point of contact for daily activities on clinical research projects, overseeing and delegating tasks to study team members globally.
- Led the development of specifications, data review, and maintenance of study documents while ensuring audit readiness.
- Mentored new team members, providing training and guidance as needed.
Senior Clinical Data Coordinator
ICON
Pennsylvania, USA
04.2018 - 04.2019
- Independently reviewed eCRFs for completeness, accuracy, and consistency, identifying and resolving data discrepancies.
- Coordinated study workflow activities, including SAE and external vendor reconciliation, user acceptance testing, and listing reviews.
- Assisted in the development and monitoring of study metrics while mentoring new team members.
Clinical Data Coordinator II
ICON
Pennsylvania, USA
10.2016 - 04.2018
- Conducted data management activities to ensure the accuracy and consistency of clinical data, adhering to company standards.
- Identified and resolved data issues within the clinical study database, performing listing reviews, edit check resolutions, and user acceptance testing.
- Generated and distributed study status metrics and provided training to new team members as necessary.
Clinical Data Reviewer
Bioclinica
New London, USA
11.2015 - 09.2016
- Reviewed and processed clinical trial data to ensure the accuracy and consistency of the clinical database.
- Conducted manual data reviews, vendor lab data reconciliation, and generated study metrics and reports reflecting the current status of the clinical database.
- Assisted in database cleaning and locking, as well as the development of study documentation.
Patient Financial Services Representative
William W. Backus Hospital
Norwich, USA
07.2012 - 10.2015
- Served as a Certified Application Counselor for Access Health CT during the 2014-2015 application period.
- Experience in patient enrollment of Medicaid/Medicare when needed.
- Managed registrations, scheduling, and insurance verifications, including Medicaid applications for newborns in the LDRP Birthing Center.
- Conducted patient interviews to gather accurate demographic and financial information, processed account receivable payments, and updated the Meditech database; served as first point of contact in ED, Main Registration, Lab, and LDRP.
- Provided financial counseling, completing presumptive eligibility applications and Access Health CT applications online.
Clinical Data Associate
INC Research
Old Lyme, Connecticut
12.2007 - 05.2012
- Reviewed and processed clinical trial data to ensure the accuracy and consistency of the clinical database
- Conducted manual data review
- Applied data handling conventions accurately and consistently.
- Performed CRF tracking, reviewing, validating
- Performd procedue testing and CRF design QC
- Assisted with database lock activities as well as database snapshots
- Conducted database discrepancy maintenance
- Facilitated tasking workflow for local and global teams
- Acted as SME for Oracle Clinical and Microsoft Excel
Senior Data and Document Processing Specialist
INC Research
Old Lyme, CT
12.2002 - 12.2007
- Provided accuate and efficient support for the preparation, distribution, processing, and shipping of CRF documentation
- Processed clinical data into clinical trial databases from hard copy or images (including 1st and 2nd pass entry as well as QC in Eclipse and Oracle Clinical
- Acted as Project Lead and SME on several projects
- Assigned tasking workflow for project team members
Data and Document Processing Specialist
INC Research
Old Lyme, CT
07.2000 - 12.2002
- Provided accurate and efficient support for the preparation, distribution, and shipping of CRF documentation
- Processed clincal data into clinical trial databases from hard copy or images (to include 1st and 2nd pass entry as well as QC in Eclipse and Oracle Clinical
Education
B.S. - Business Administration
Charter Oak State College
New Britain, CTSkills
- Microsoft applications
- Word
- Excel
- Outlook
- PowerPoint
- Teams
- Clinical Data Management
- Medidata Rave
- Local Lab Module management
- Sharefile
- SharePoint
- Smartsheet
- Cross-functional team communication
- sFTP
- Vendor reconciliation specification development
- Manual data listing specification development
- Trial Interactive
- eTMF
- CRF design
- DVP development
- QC
- Post-production changes
- SAE Reconciliation
- Vendor / Central Lab Reconciliation
- Audit readiness
- Database migrations
- JReview
Certification
CCDM – Certified Clinical Data Manager, Society for Clinical Data Management (SCDM)
Timeline
Senior Clinical Data Manager
Caidya
03.2020 - Current
Clinical Data Lead
ICON
04.2019 - 02.2020
Senior Clinical Data Coordinator
ICON
04.2018 - 04.2019
Clinical Data Coordinator II
ICON
10.2016 - 04.2018
Clinical Data Reviewer
Bioclinica
11.2015 - 09.2016
Patient Financial Services Representative
William W. Backus Hospital
07.2012 - 10.2015
Clinical Data Associate
INC Research
12.2007 - 05.2012
Senior Data and Document Processing Specialist
INC Research
12.2002 - 12.2007
Data and Document Processing Specialist
INC Research
07.2000 - 12.2002
B.S. - Business Administration
Charter Oak State College