Pavan Suryakumar Email & Phone Number

Bangalore

Application Devl Spec 2, CDP –Delivery Lead• Responsible for overall Project Management which includes resource management, quality and delivery for major Pharma Company on InFormplatform.• Support in build and maintenance of Global Library objects.• Responsible for training and mentoring colleagues.• Efficiently resolve escalations.• Negotiate timelines with clients/vendors.• Review vendor budgets and contracts.• Collaboration between Programming team and Data Validation team.• Process Improvements.• Maintain Sponsor dashboard, KPIs’ and metrics.

Bangalore, India

•Responsible for overall Project Management which includes resource management, quality and delivery for major Pharma Company on OC-RDC, RAVE platforms.•Manage a team of 6 resources.•Responsible for training and mentoring colleagues.•Efficiently resolve escalations.•Performing Root Cause Analysis (RCA) and provide Corrective and Preventive Actions (CAPA) and checking the effectiveness of the corrective actions.•Validation of SDTM datasets using mapping specification•Negotiate timelines with clients/vendors.•Review vendor budgets and contracts.•Collaboration between Programming team and Data Validation team.

Bangalore

Copenhagen Area, Denmark

•Responsible for overall Data Management deliverables during trial Start-up, Conduct and Closure according to ICH/GCP.•Create CRFs’, edit specifications, validate the EDC system and prepare Data Management plans, handle Database locks and their documentation.•Create specification and validate Integrations with the CDMS and other GxP systems during trial build.•Ensure DM activities are performed and documented as per the Protocol and Standard Procedures. •Negotiating timelines with CROs’, vendors, reviewing vendor budgets, contracts. •Provide data trends to the Study Group during and adhoc reports using SQL on a regular basis.•Involved in Standardization and Process improvement project.•Chair meetings with vendors, key stake holders.•Chair Study Group meetings and provide updates on the Data Management activities.•Chair regular meetings with the DM team to understand the current status and provide inputs in case of any issues.•Provide regular updates to Project Data Manager and proactively identify and communicate risks and mitigation plans.

Copenhagen Area, Denmark

Responsible for overall Data Management deliverables during trial Start-up, Conduct and Closure according to ICH/GCP.•Create CRFs’, edit specifications, validate the EDC system and prepare Data Management plans, handle Database locks and their documentation.•Create specification and validate Integrations with the CDMS and other GxP systems during trial build.•Ensure DM activities are performed and documented as per the Protocol and Standard Procedures. •Negotiating timelines with CROs’, vendors, reviewing vendor budgets, contracts. •Provide data trends to the Study Group during and adhoc reports using SQL on a regular basis.•Involved in Standardization and Process improvement project.•Chair meetings with vendors, key stake holders.•Chair Study Group meetings and provide updates on the Data Management activities.•Chair regular meetings with the DM team to understand the current status and provide inputs in case of any issues.•Provide regular updates to Project Data Manager and proactively identify and communicate risks and mitigation plans.