Divya Soma Email & Phone Number

Canada

• Served as a primary point of contact for Client on data management deliverables.• Participating in designing of Electronic Data Capture (EDC) databases and ensuring that they fulfilled the criteria for the entry and reporting of clinical data.• Managed three studies concurrently with a team of four for each project. Conducted team meetings, managed weekly schedules, and ensured the accuracy of timesheets and Data Management (DM) Status Reports.• Developed and Maintained project documents like Data validation documents, Data Management Plan (DMP), CRF completion guidelines (CCGs), Data Transfer Agreements (DTA).• Executed SAE reconciliation and external vendor data reconciliation for several clinical trials.• Generated Metrics Report to track the status of the study.• Involved in project budget estimation by accessing the cost,time, and resources required for the study.• Responsible for supporting database-locking activities, includingplanning, and executing listing reviews and identifyingremaining clinical and monitoring tasks.• Tracked status and progress of data management for allocatedprojects/trials.• Contributed towards developing guidelines/checklist that aids instreamlining of activities for Data Management (DM) during study closeout.

• Handling Scope of Work (SOW), budgets, estimates, timelines, deliverables, milestones, success, and risks allocated to CDM/ePRO studies.• Participated in Study Kick Off meeting and Clinical Trail Team meetings for assigned studies and maintaining an adequate level of support and coordination.• Collaborating with different stake holders of the study to develop Case Report forms (CRFs) and participating in designing of Electronic Data Capture (EDC) databases and ensuring that they fulfilled the criteria for the entry and reporting of clinical data.• Developed test scripts and execution logs for User Acceptance Testing (UAT) and performing UAT on Forms and Edits for new studies during the development phase.• Ensured study went live according to the timeline.• Helped in developing and maintaining study documentsincluding CRF completion guidelines, DMP, Data validationdocuments.• Performed database validation/Quality Control tests incompliance with Standard Operating procedures, clientguidelines and regulatory agency guidelines.• Performed soft lock and hard lock of the database at thecompletion of the study after thorough QC of data.

• Performed data management tasks: data review, discrepancymanagement, listing review, quality control and reportedstatus reports to client.• Generated and reviewed EDC/UAT functionality,comprehensiveness and edit checks.• Assisted in developing case report forms and CRFcompletion guidelines.• Assisted the Clinical Data manager with manual datareviews and worked with database lock activities.• Performed a weekly task which includes SAS listingsreview, IVRS and LAB reconciliation, SAE reconciliation, Important Protocol Deviation (IPD) review, handling, and documentation.• Responsible for performing Database User Acceptance Testing (DB UAT) and Edit Check User Acceptance Testing (EC UAT) for the assigned studies.• Update the Communication log with the findings from UAT and follow up the Database developing team.• Responsible for performing the Discrepancy management, raising Data Clarification forms, updating the communications logs and trackers.

• Finalize the conference theme and schedule, ensuring no date conflicts with other events.• Assist clients and plan the conference budget with the Conference Manager.• Design scientific sessions/tracks based on recent advances and developments.• Invite target audiences, including professors, scholars, students, and industry leaders worldwide.• Generate leads for registrations and abstracts.• Serve as the main contact for program hosts, session chairs,scientific committees, and speakers.• Coordinate with clients, management, speakers, andpresenters to arrange sessions, poster boards, and exhibits.• Maintain contact with professors, managing directors, andCEOs to establish collaborations and customer relationships.• Monitor financial information, produce final statements(budget, actuals, profit/loss, balance sheet) for the Conference Manager/management.

Bachelor'S Degree, Biotechnology

Master'S Degree, Microbiology And Immunology