Medidata Rave
Evgeniy Shpuntov
Clinical Data Management Lead
Mortsel,VAN
Summary
A focused and ambitions Global Data Manager with 12 years of experience who consistently improves and delivers high standard projects. Good problem solving and communicative character. I want to succeed in a stimulating and challenging environment, building the success of the company while I experience advancement and developing opportunities.
Overview
12
12
years of professional experience
3
3
Languages
Work History
Principal Data Manager
IQVIA
2022.11 - 2025.01
- Performed a Trial Level Oversight on the assigned trials
- Served as point of escalation at client/sponsor relationship level
- Created and executed timelines on the assigned studies
- Managed a team of junior CDMs, QCed hands on activities
- Forecasted resources/budgets on the assigned studies
- Performed Bid-defense before before senior management
- Streamlined clinical data management workflows for increased efficiency and reduced processing time
- Performed Risk assessment
- Ensured successful Cross-team collaboration (Stat, Clinical, GCO etc)
- Oversaw Data Archival/TMF QC
- Worked with Third Party Vendors for successful delivery of Data Transfers
- Trained team members in best practices for data handling, improving overall productivity and data integrity
- Served as Study Data Manager when resources are limited
Project Manager - Clinical Data Management
PPD (ThermoFisher Scientific)
2021.09 - 2022.11
- Performed a Trial Level Oversight on the assigned trials
- Served as point of escalation at client/sponsor relationship level
- Created and executed timelines on the assigned studies
- Managed a team of junior CDMs, QCed hands on activities
- Forecasted resources/budgets on the assigned studies
- Performed Risk assessment
- Ensured successful Cross-team collaboration (Stat, Clinical, GCO etc)
- Overseen Data Archival/TMF QC
- Worked with Third Party Vendors for successful delivery of Data Transfers
- Trained team members in best practices for data handling, improving overall productivity and data integrity
- Served as Study Data Manager when resources are limited
Data Acquisition Manager/Data Delivery & Oversight Lead
UCB
2019.09 - 2021.09
- Performed compound and trial level oversight across multiple studies
- Managed CROs and third-party vendors to ensure quality and compliance
- Oversaw medical coding activities and ensured accuracy
- Developed and maintained project timelines to meet deliverables
- Identified and mitigated operational and project risks
- Collaborated with cross-functional teams (Statistics, Clinical, GCO, etc.) to align project goals
- Performed data and metadata QC checks (SDTM)
- Ensured data archival and maintained inspection readiness (TMF)
- Authored and developed standard processes to improve efficiency
- Led vendor selection and conducted interviewing for new partnerships
Senior Clinical Data Lead
GSK
2019.02 - 2019.09
- Performed Compound Level Oversight
- Served as point of escalation at client/sponsor relationship level
- Performed timelines creation and execution
- Managed team of junior Data Managers, resources and budgets management
- Performed resources and budgets management
- Forecasted finances up to study closure/DB lock
- Performed risks management
Lead Global Clinical Data Manager
Janssen Pharmaceutica (Johnson&Johnson)
2015.07 - 2019.02
- Performed trial-level oversight on assigned studies
- Managed CROs and third-party vendors to ensure compliance and quality
- Collaborated with cross-functional teams (Statistics, Clinical, GCO, etc.) to align project goals
- Led initiation and creation of study documentation (DMP, DVP, DTAs, etc.)
- Developed and executed study timelines to meet milestones
- Ensured accuracy through data and metadata quality control (SDTM)
- Oversaw data archival and maintained inspection readiness (TMF)
- Mentored junior staff to support professional growth and knowledge transfer
Lead Clinical Data Manager
Synergy Research Group
2015.03 - 2015.07
- Served as Lead Data Manager on several projects
- Ensured successful launch, delivery, and completion of data management activities
- Monitored projects and provided regular status reporting
- Managed project budgets and oversaw changes of scope
- Designed, prepared, and reviewed study documents (UAT plan, DVR, DVP, eCCGs, DTS, etc.)
- Conducted clinical database testing and edit checks testing
- Performed data quality control to ensure accuracy and compliance
- Oversaw query management throughout the study lifecycle
- Managed data entry specialists and coordinated their activities
Clinical/Lead Data Associate
PPD(ThermoFisher Scientific)
2013.01 - 2015.03
- Performed hands-on clinical data management activities
- Oversaw query management and resolution
- Conducted detailed data review to ensure accuracy
- Performed data reconciliation across multiple sources (SAE, ECG, IWRS, PK, etc.)
- Executed data quality control and managed data archival
- Conducted database testing to validate system functionality
- Designed and executed edit checks testing
- Mentored junior staff to support development and knowledge transfer
Backoffice Telecom Specialist
MTS Group
2012.08 - 2012.12
- Ensured service maintenance
- Performed clients budget control
- Managed client budget rates within the system
- Liaised with client’s personal managers
- Executed customer requests within the system
Education
Master of Science - IT Science & English
Smolensk State University
Smolensk, Russia2012-07
Professional Development, Trained While Employed -
Multiple Organisations
Multiple Locations2025-01
Skills
Project Management
Data Review
Query Management
Conduct
Testing & Validation
Team management
Resource/budget management
Data QC
Timelines management
SDTM
CRF Design
Standards Management
TA PROFICIENCY
- Oncology – Phase I, II, III
- ID&V – Phase I, II
- Hematology – Phase I,II
- Rare diseases - Phase I, II, III
- Respiratory – Phase I, II
Hobbies
- Snowboarding
- Hiking
- Brewing/Lambiek blending
- Gaming
Software
MS Office
SAS
QlikSense
CMDR
Veeva Vault TMF
Timeline
Principal Data Manager
IQVIA
2022.11 - 2025.01
Project Manager - Clinical Data Management
PPD (ThermoFisher Scientific)
2021.09 - 2022.11
Data Acquisition Manager/Data Delivery & Oversight Lead
UCB
2019.09 - 2021.09
Senior Clinical Data Lead
GSK
2019.02 - 2019.09
Lead Global Clinical Data Manager
Janssen Pharmaceutica (Johnson&Johnson)
2015.07 - 2019.02
Lead Clinical Data Manager
Synergy Research Group
2015.03 - 2015.07
Clinical/Lead Data Associate
PPD(ThermoFisher Scientific)
2013.01 - 2015.03
Backoffice Telecom Specialist
MTS Group
2012.08 - 2012.12
Master of Science - IT Science & English
Smolensk State University
Professional Development, Trained While Employed -
Multiple Organisations