Jeewan Prasad

A self-motivated Life Science professional with over 11+ years of experience, around 10 years in core Data Management. Complete exposure in Clinical data management activities from study Set-up, Conduct, Closure (DBL) and Post DBL submission activities. 

Technical skills:

Set-up:                                Protocol Review, Creation of Project Plan, Project specific List of SOPs, Facilitate DM Kick-Off meeting (KOM), TPV KOMs and creation of Data Transfer Agreement, SAE Recon Set-up, Creation of Data Status Report (Spotfire) specs, EDC Cleaning Plan, DM Communication Plan, Creation of Targeted Source Document Verification (tSDV) specs & Remote monitoring plan, RBS & ALS review, Data Validation Plan, eCRF Design & setup, Edit/dynamic checks specs for data consistency, SAE & other External Vendor Data transfer specs & setup, Missing Page Report Specs, Global Physician Report Specs, Local Lab Reference Range setup, Budget Estimation, Setting up e-Trainings folders, Creation of Data Management Quality Plan, Online screen review meeting, setting up distribution list for SAE and other email alerts, RACI setup, Setting up EDC & non-EDC access, Unblinded data setup, Outbound data transfer setup, Coding setup as per Data Coding guidelines, CRF UAT activities, eTMF & Veeva Vault setup for filing key documents.

Conduct:                            Setting up SAS listings, Creation of Custom Reports Guidelines, Data review, data cleaning, discrepancy management, Clean Patient Tracker Specs & review, SAE & other TPV Data Reconciliation, Post-production changes, Programming Requests & Change Forms, monthly Task Planner, monthly Invoice and billing, Create Overall Status of Studies, e-training compliance maintenance, ensure filing and archival of documents in Veeva Vault eTMF, Key Team Member Transition Checklist, Risk Impact assessment review, monthly Sponsor meeting, Run and review double byte character report, review all coded data, review all local lab data. QC of review.

Close-out:                          Ensure all EDC & TPV data is cleaned, SDV’d, Signed, Frozen and Locked on time. Creation of Database Lock checklist, Mandatory forms review in inactivated pages report, review completion of GPR, CPT review, Run dataset count report, Document & Authorize deviations in Data Handling Report, Ensure EDC & non-EDC access revoked for all, Ensure all e-trainings completed and documented, Ensure all documents filed in Veeva Vault TMF.

EDC Platforms:                   RAVE, InForm, Express, MERGE eClinicalOS, ACM Labstar, Oracle Clinical OCRDC, DS Navigator (MedDRA, WHODRUG) & Oracle Argus. Pharmacy management tools like QS1/QS4, Best Rx & Prime Rx. Pharmacy supply management tool McKesson.

Specialties:                         Project Management, Team Management, Client Relationship, Process Improvement.

Therapeutic area:              Oncology, Cardiovascular, GIT, COPD & Observational study (PMS/Phase IV – Device).

Seminar:                             Attended Data Team Lead Conference in London, UK.

Achievements:                   Won Ovation award in IQVIA Impact Program for customer centricity, ownership, and 

flexibility towards database lock. Trainer for Programming Requests & Change Forms for AZ DM process, Mentoring new ADTLs, Trainer of Roles & Responsibilities for new joiners.

MS in Pharmaceutical Administration

St. John’s University, New York, US (Sep 2006 – May 2008)