Prathibha Prabhakaran

Experience

• 

  Jubilant Biosys

  Feb 2004 - Feb 2007

  Scientist

  • Overlooking the curation and quality check done by designated persons. • Quality Check of papers that came out of curation.• Delivery of the product in UNIX format.• Uploading of mined data to the ftp site of CAS.• Training of new joiners in the field of cancer research, biotechnology, pharmacology, microbiology, biocomputing, bioinformatics and also in the aspect of curation and GLCV.

• 

  Quintiles

  Oct 2007 - Aug 2010

  • Serve in the role of back-up to a Data Operations Coordinator or Data Team Lead.• Resource management and work allocation within the team• Trial start up processes like  eCRF design,  Front end build User acceptance testing UAT documentation Local lab building (LNMT) Identifying DQRs writing test conditions and edit check specifications Providing specifications for listings and user acceptance testing in SQL developer.• Trial Conduct processes which includes Discrepancy management in eCRf data ECG Data review DNA Data review Pharmacokinetic/Pharmacodynamic Data review Protocol deviation review IVRS Data review Lab review  M-Protein Data Review.• Mentoring team-members for an observed increase in performance • Overall planning for project timelines and deliverables.• Preparation and submission of documents for audit trial.Key Achievements:• Promoted to Clinical data coordinator with in 1.5 years based on consistent performance• Two Years of extensive work experience with prestigious pharmaceutical clients.• Extra effort Award for constantly meeting time-lines with 100% quality• Applause award for outstanding performance.• Appreciation from Internal & External clients • Part of the team for 3 Successful data base locks in which one drug has been commercially launched in market and 2 are under FDA submission.• Part of the team for 2 Interim data base lock for oncology studies.• Single handedly built a data library for oncology (lymphoma and multiple myloma) studies to help the clinical data managers with data review.• Single Point of contact for the entire project related matters for the client.• Special achievement award for outstanding performance. Show less

  • Clinical Data co-ordinator

    Apr 2009 - Aug 2010

  • Associate Clinical Data co-ordinator

    Oct 2007 - Apr 2009
• 

  Novo Nordisk

  Aug 2010 - Mar 2020

   End to end project management for large clinical trials.  Project planning in collaboration with Trial Management team.  Training of Investigators and Monitors. Risk analysis and management. Represent Data Management in Investigators & Monitors, International Study Group Meetings. Ensuring quality of data and processes within and across projects. Planning and execution of DM timelines during startup, conduct, close-out and submission starting from trial outline to CTR.  Chairing Data Quality Review meetings and Data Base Lock Meetings. Alignment of processes across the clinical trials within Projects,  Vendor Management. Contract Reviews. Global project team management. Resource management with in the project team. Ensuring Audit/inspection readiness of the project team Ensuring the project/trial level documentations Trainings for Data Management Department. Review of standard operation procedures (SOPs). Preparation/review of key data management Documents like Blinding plan, Data Handling protocols (DHP/DMP), mock eCRF, eCRF Specification, edit check specification, UAT Plan, Interface Mapping Documents, Lab Specifications and Annotations, Trial Validation Plan, Data Flow Plan, Data Handling Decisions, QC Documents, Data Base Lock Minutes etc. INFORM EDC Super user (Subject matter expert) for Data Management representing Indian data management operations. Show less • Project Management • Vendor Management • Global project team management• Project planning.• Trial Planning during trial conduct and trial Closure• Co-ordination of clinical data with various departments in clinical trial.• Project related documentation for auditing.• Review and preparation of project/trial specific documents and contracts in start-up, conduct and close-out period.• Training investigators and monitors in data management aspect of the trial.• Risk Assessment.• Work allocation for resources.• Data Base lock.• Discrepancy management.• Mentoring team members.• Managing the trial team.• End to end planning to ensure a smooth study process till CTR finalization.• Responsible as face of DM AUDITEE during an audit for the allocated studies. Show less • Project Management• Perform trial planning, trial set up and trial execution on DM issues on a level that secures data is collected and validated in the clinical database before data analysis in a timely manner and to the right quality level.• Co-ordination of clinical data with various departments in clinical trial• Project related documentation for auditing.• Preparation of project related documents.• Co-ordination with external vendors for data transfer.• Preparation of data management plan (Data flow Plan)• Communication with monitors• Training investigators and monitors in data management aspect of the trial.• Risk Assessment.• Mentoring new joiners.• Knowledge sharing through share better practice sessions• Discrepancy Management• Preparation of Edit check specification. Show less • Project Management • Vendor Management • Global project team management• Project planning.• Trial Planning during trial conduct and trial Closure• Co-ordination of clinical data with various departments in clinical trial.• Project related documentation for auditing.• Review and preparation of project/trial specific documents and contracts in start-up, conduct and close-out period.• Training investigators and monitors in data management aspect of the trial.• Risk Assessment.• Work allocation for resources.• Data Base lock.• Discrepancy management.• Mentoring team members.• Managing the trial team.• End to end planning to ensure a smooth study process till CTR finalization.• Responsible as face of DM AUDITEE during an audit for the allocated studies. Show less

  • Associate Manager

    Nov 2019 - Mar 2020

  • Team Lead

    Aug 2016 - Nov 2019

  • Lead Clinical Data Manager

    Oct 2015 - Jul 2016

  • Senior Clinical Data Manager

    Apr 2014 - Oct 2015

  • Data Manager

    Aug 2012 - Apr 2014

  • Senior Clinical Data Coordinator

    Aug 2010 - Aug 2012
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  Eli Lilly and Company

  Apr 2020 - now

  • Associate Director- Clinical Data Sciences

    Dec 2023 - now

  • Senior Manager, Neuroscience-Clinical data sciences

    Mar 2022 - now

  • Manager, Neuroscience-Clinical data sciences

    Apr 2020 - Mar 2022