Devayani S Email & Phone Number

Whitby, On, Ca

Canada

• Reviewed protocols and participated in the development of study-related documents such as data management plan, data validation specification, eCRF Completion guideline and data entry guidelines (CCG).• Prepared Study set-up documents like Mock Case Report Forms, Edit-check specifications, CRF completion guidelines, Data Review plan, Third party protocols, Data Handling plans etc.• Contributed to the creation of Data transfer specifications (DTS), eCRF (Electronic Case Report Form) specifications, Test Scripts and SAS listings.• Performed discrepancies management, vendor reconciliation, eCRF Listings review and generate queries for the discrepancies identified during the review.• Worked on various study setups, conduct and closeout activities. • Worked closely with RAVE and Inform developers on the design, testing (UAT) and implementation of clinical databases.• Worked on postproduction changes like drafting postproduction change requests and their implementation.• Performed UAT as per the test scripts and created edit check specifications (ECS), e CRF specification for database testing during the start-up phase before Go Live.• Ensuring the final database DM documents are complete and all data issues have been tracked, reviewed, reconciled, and resolved as per SOPs.

India

Performed Data Management tasks: data review, discrepancy management, listing review, quality control and reported status to the client.• Generated and reviewed EDC/UAT functionality, comprehensiveness and edit checks.• Assist in developing case report forms and CRF completion guidelines/specifications.• Perform weekly tasks which include ECG and LAB reconciliation, SAE reconciliation,handling and documentation.• Responsible for performing Database User Acceptance Testing (UAT) and Edit Check UserAcceptance Testing (EC UAT) for the assigned studies.• Update the Communication log with the findings from UAT and follow up with the Database developing team.• Responsible for performing Discrepancy management, raising Data Clarification forms, and updating the communications logs and trackers.• Freeze and lock the data on time for preparing the database for statistical review, interim quality review and final database lock.• Maintaining quality control on the database as per required guidelines.• Providing input to vendor data transfer specification document.• Maintaining study-related documents in Trial Master File.• Responsible for developing reports for safety as per study requirements.• Worked with different clinical trial data like Demographics, Medical History, Vital signs,Adverse Event (AE), Physical examination.

India

Designed case report forms (CRFs).• Involved in the preparation of DMP and eCRF completion guidelines and otherDM related documents.• Responsible for performing the Database lock activities, like planning andexecuting listings review, identifying remaining clinical and monitoring tasks.• Performed Quality Check (QC) of the data by manual review.• Generated and reviewed EDC/UAT functionality and Edit Checks.• Developed and executed queries in clinical databases.• Created and reviewed CRF Completion Guidelines document.• Performed Lab, SAE and external-vendor data reconciliation in several clinical trials.• Contributed towards developing guidelines/checklist that aids in streamlining ofactivities for Data Management (DM) during study close-out.• Played a key role in the closing of database lock.• Ensured FDA regulatory standards compliance (particularly 21 CFR Part 11) andperformed quality assurance on various electronic data capture tools.