Krishna Jain Email & Phone Number

Voorhees Township, Nj, Us

Morrisville, Nc, Us

• Led coordination of two clinical studies with different sponsors, ensuring timely delivery of all Data Management activities and milestones.• Managed financial aspects of projects, including revenue recognition and scope changes, leading to successful project outcomes.• Developed and maintained project plans, CRFs completion guidelines, and documentation in line with SOP requirements.

Morrisville, Nc, Us

Morris Plains, New Jersey, Us

• Provided Clinical Data Management support for data management tasks throughout the trial lifecycle with minimal oversight on one large breast cancer study.• Assist with ensuring efficiency and consistency for data management tasks across a program.• Participate in weekly internal team meetings and provided progress on listing review• Perform manual review/QC checks on seven different data points in Veeva Vault.Perform reconciliation on imaging data from the assigned vendor. Run four different reports and built a metric report for clinical and site staff weekly. Assist in writing, tracking, notifying the Clinical queries on regular basis.

• Provided Clinical Data Management support for data management tasks throughout the trial lifecycle with minimal oversight on two studies.• Assist with ensuring efficiency and consistency for data management tasks across a program.• Interact with sponsor and clinical CRO in support of questions and/or data issues (if applicable).• Participate in internal study kickoff meetings and client study closeout/lessons learned meeting.• Perform manual review/QC checks as listed in the Data Validation Specifications using• exception listings and reporting tools.• Perform reconciliation for five different external vendor files ensuring data is in alignment with the clinical database and Data Transfer Agreement.• Assist with development of Data Management documents including DMPs, eCRF Completion Guidelines, CRFs, and Help Text.• Assist with the development of eCRF and edit check specifications.• Assist with database QC and Internal System Testing (IST) on the database/user roles/edit check specifications.• Attend internal study team and sponsor team meeting weekly.• Assist with development of data transfer agreements (DTAs) between external data vendors and/or core labs.• Identify data issues and/or data trends, communicate to the Clinical Data Management team and assist with development of action plan.• Assist with development of specifications and collaborate with programming for programming and QC of manual listings, external data reconciliation, metrics reports as needed (every week) throughout the study.• Run and review data management metrics reports, provide insights into the metrics to the Sponsor.• Assist with defining and developing specifications for database, programming and/or edit check changes as needed throughout the study.

• Act as Co lead Senior Data Manager assigned Data management project – responsible for two studies – Rare Disease.• Define Edit checks to be programmed for the study • Perform User Acceptance Testing (UAT) on edit checks.• Perform data review and query generation• Database reconciliation with external data files on 4-8 files each month.• Perform thorough listing review (Standard and Study specific forms) monthly on two studies.• Execute status reports on both studies and distribute to the entire team on weekly basis.• Update the database to correct errors.• Attend Sponsor meetings weekly.• Train India team for extensive data review and external Data reconciliation.All above activities are being done in Medidata Rave – Phase IIB studies and BioClinica Express version 5.4.

Reston, Virginia, Us

• Experience in Rave Medidata. Wrote edit checks for study specific validation, tested Case Report forms, also wrote test scripts for testing case report forms in Medidata RAVE.• Experience in CaDSR (NCI browser). Look up correct medical terms needed for the study, created new module and added into case report form. • Modality Review on three different studies (breast, and GI cancer studies) – Performed modality review on two or more chemotherapies, queried to the sites, Sent modality review to study medical oncologist with all required documentation.• Answered all eligibility and chemotherapy related questions from all sites regarding the exceptions of the breast and GI studies.• Continuously communicated with the sites on issues and responded on study data issues.• Serious Adverse Event (SAE) reconciliation on three ongoing studies.• Continuous data review on all ongoing studies, queried accordingly, and resolved issues.• Ran validations on 10+ studies each month and resolved accordingly

• Coordinate loading, reviewing, and correcting of External Laboratory data for several protocols of a Rheumatoid Arthritis Study.• Facilitate the setup of vendor’s databases correctly prior to enrolling the first patient in the first study• Ensures accuracy of requisition forms from vendors for each visit of study before study starts. • Review, monitor, and provide comments on monthly Laboratory Data reports prepared by other team members to ensure accuracy • Create and update database specifications and communicate this information to vendors• Participate and provide input in data management monthly meetings• Integral part of setting up first ePRO (electronic patient reported outcomes) database for company• Communicate with many different vendors and team members to ensure accurate and quality data management for multiple ongoing projects occurring at the same time

Rahway, New Jersey, Us

• Reviewed and supported data management tasks for development of anti-infective drug (INVANZ)• Supervised and coordinated a staff of five assistant Data Management Coordinators during Phase III (INVANZ) trial• Updated critical documents include Data Handling Guidelines, Data Reviews, Monitoring Plans, Query interpretation guidelines, and Clinical Summary Reports (CSRs) • Supported locked data base activities for several Vaccine and Drugs projects • Supported day-to-day data management activities for vaccine and drug projects • Executed CSRs and delivered Item 11 deliverables, including SAS transport files, Data Definitions, and Annotated Case Report Forms (CRFs)• Developed project-specific Clinical Summary Reports (CSRs) specifications for the project and coordinated user acceptance testing efforts between data management and statistician• Wrote program specifications and performed database testing using dummy data

Computer Programming Diploma, 6 Different Computer Languages

Science, And Human Science