Ashish Bagde
Brussels,Belgium
Summary
Strategic clinical data operations leader with 17 years of global experience across pharma and CROs, excelling in outsourced data management (DM), CRO oversight, project governance, people management, and cross-functional delivery. Proven track record in managing multimillion-euro budgets, building high-performing global teams, and ensuring compliant, quality-driven data delivery across complex portfolios. Adept at strategic partner management, KPIs/metrics reporting, contract negotiations, and risk mitigation. Contributor to SCDM as EMEA Steering Committee Member and member of the EMA ACT EU multi-stakeholder platform.
Overview
17
17
years of professional experience
2009
2009
years of post-secondary education
Work history
Study Data Lead
UCB Belgium
, Belgium
08.2022 - 02.2026
- Accountable for deliveries of end-to-end data operations and oversight of global data operations.
- Oversee vendor activities ensure activities are completed according to the SOW, timelines and with expected quality.
- Provide functional solution to team and act as functional leader as well as provide direction to CRO.
- First point of contact with internal team & external vendors for any DM related communication.
- Create/review/approve DM documents & ensure audit-readiness.
- Ensure TMF completion for all DM related documents.
- Ensure external data loading/deliveries and integration activities are done as per process.
- Review/approve DM budgets throughout the project lifecycle also manage out of scopes.
- Track status of projects using defined KPIs, and share them with project team as well with management.
- Ensure quality data deliveries for key milestone such as Interim analysis, DMCs & DBLs.
- Drive vendor governance meeting (DM part) & BID defence meeting.
- Initiate innovation/process improvements, gap assessment on current processes also for platforms/tools to enhance operational efficiency.
- Build and mentor DM & cross-functional team.
- Manage resource assignments & ensure optimal use.
- Maintain varies matrix to ensure projects/ team performance are on track.
- Proactively identify risk, highlight it to relevant stakeholders & perform corrective action.
- Assist management for yearly performance evaluation for resources.
Data Management Leader
Galapagos NV
Mechelen, Belgium
09.2020 - 07.2022
- Accountable for deliveries of end-to-end data operations and oversight of global data operations.
- Provide functional solution to team and act as functional leader as well as provide direction to CRO.
- First point of contact with internal team & external vendors for any DM related communication.
- Create/review/approve DM documents & ensure audit-readiness.
- Ensure external data loading/deliveries and integration activities are done as per process.
- Oversee vendor activities ensure activities are completed according to the SOW, timelines and with expected quality.
- Review/approve DM budgets throughout the project lifecycle also manage out of scopes.
- Track status of projects using defined KPIs, and share them with project team as well with management.
- Ensure quality data deliveries for key milestone such as Interim analysis, DMCs & DBLs.
- Manage resource assignments & ensure optimal use.
- Maintain varies matrix to ensure projects/ team performance are on track.
- Proactively identify risk, highlight it to relevant stakeholders & perform corrective action.
- Assist management for yearly performance evaluation for resources.
Consultant, Data Management
Excelya Data
Paris, France
11.2018 - 08.2020
- Oversee and coordinate all DM activities, deliverable & timelines for assigned projects/programs throughout the project lifecycle.
- Provide data management solution to team & act as SME as well as provide direction to junior DMs.
- Ensure team maintains documents are ready for audit/ inspection.
- Ensure team/vendors adhere to project plan, timelines and budget.
- Involved in pre-sales activities, manage budget/finance also handle out of scopes.
- First point of contact for DM delivery/ DM issues on program level.
- Review budget and negotiate with vendor/CRO including out of scope.
- Maintain varies matrix to ensure projects /team performance are on track. Highlight the risk to management.
- Ensures proactive communication with DM team and other stakeholders.
- Mentor team on specific activities/process & track their performance and provide constructive feedback.
Data Manager
AB Science
06.2018 - 10.2018
- Worked for short duration, was mainly involved in process improvement related activities and conduct phase (data cleaning) activities.
Manager, Data Management
Dr. Reddy's Lab
Hyderabad, India
07.2013 - 01.2017
- Played key role to establish DM department at organization level, (EDC set-up, process & SOPs).
- Program level/ project leader for multiple DM projects.
- Oversight and management of FSP providers, ensuring contract creation/ renewal, contract compliance and cost review of FSP providers/CRO.
- Involve in FSP vendor /CRO evaluation and establish SOW, including SOW review.
- Categorize and execute solutions to data management issues and concerns.
- Primary point of contact with internal, external functional leaders & vendors.
- Effective oversight and management of DM deliverable.
- People management: hiring, goal setting, mentoring, resource utilization, performance evaluation.
Data Management Team Leader
Axis Clinicals
Hyderabad, India
07.2012 - 07.2013
- Project leader for multiple DM projects.
- Accountable for documentation for projects. management.
- Primary point of contact with internal, external functional leaders & vendors.
- Team management: hiring, goal setting, mentoring, resource utilization, performance evaluation.
- Involved in budgeting, managing scope of change etc.
- Managed & facilitated in internal & external audits.
- Proactively took part in the development of SOPs, processes and procedures.
- Created/reviewed DM documents, guidelines for set-up, conduct and close-out activities.
- Designed/reviewed/approved all documents for DM function.
Data Management Team Leader
Cognizant Technology Solutions
Mumbai, India
11.2010 - 06.2012
- Lead multiple DM projects & coordinated daily activities of the team.
- Direct communication with sponsor & cross function team.
- Worked at sponsor location to get the new business process/model.
- Reviewed & approved DM documents for project set-up, conduct and close-out phase.
- People management: hiring, goal setting, mentoring, resource utilization, performance evaluation.
- Monitored and communicated project progress to sponsor & project team.
- eTMF management for internal and external audits.
- Involved in budgeting: creation of RFPs, managing.
Clinical Data Manager
GVK Biosciences
Gurgaon, India
09.2008 - 11.2010
- Handled DM projects independently.
- Direct communication with Sponsor & cross function team.
- Tracked periodic study progress status report and shared with cross function team.
- Handled discrepancy management/data cleaning activities.
- Assist senior data managers from database set up till database lock for various DM activities.
Education
Certificate - Clinical Research and Data Management
University of Pune
Pune, IndiaMasters - Biotechnology
Pt. Ravishankar Shukla University
Raipur, India 07.2003 - 06.2005
Skills
- Data operations oversight
- Operations strategy and governance
- Vendor performance management
- Project/ program management
- Relationship management
- Budget review and resource forecasting
- Stakeholder engagement
- Risk management
- Audit readiness
- Vendor selection and contract negotiation
- Process optimization and improvement
- Basic knowledge of CDASH, SDTM
- Tools: Medidata Rave, OC, OCRDC, Clinion, Acceliant, SAS PheedIt
- People management
- Helped SCDM to launch GCDMP, CCDA & CCDS certification
- European Medicines Agency (EMA) ACT EU multi-stakeholder platform member
Websites
Timeline
Study Data Lead
UCB Belgium
08.2022 - 02.2026
Data Management Leader
Galapagos NV
09.2020 - 07.2022
Consultant, Data Management
Excelya Data
11.2018 - 08.2020
Data Manager
AB Science
06.2018 - 10.2018
Manager, Data Management
Dr. Reddy's Lab
07.2013 - 01.2017
Data Management Team Leader
Axis Clinicals
07.2012 - 07.2013
Data Management Team Leader
Cognizant Technology Solutions
11.2010 - 06.2012
Clinical Data Manager
GVK Biosciences
09.2008 - 11.2010
Masters - Biotechnology
Pt. Ravishankar Shukla University
07.2003 - 06.2005
Certificate - Clinical Research and Data Management
University of Pune