Soniya Johnson

1. Successfully completed role-specific training to ensure compliance with job responsibilities and regulatory standards.

2. Preparation i-site packs for assigned sites using study-specific reports, supporting efficient site initiation and monitoring for assigned studies.

3. Maintain proactive communication with CRAs and site staff to resolve outstanding data issues including EDC open queries and missing pages, SDV backlog, TMF missing documents, missing lab samples, and investigator payment related queries.

4. Perform centralized monitoring activities on assigned sites and evaluate their quality and integrity as per the protocol, SOPs respective regulation and guidelines.

5. Conduct periodic review of site level KRIs and site performance according to Central Monitoring Plan and provide inputs to CMS leads to enable Early identification of site-level risks or issues.

6. Analyzing study data to identify potential protocol deviations at the subject level across assigned sites, ensuring compliance with study protocol and regulatory requirements.

7. In collaboration with Team lead handled Investigator Payment review for assigned studies during project lifecycle as per Clinical Trial Agreement and in compliance with ICH GCP guidelines.

8. Supported cross-functional collaboration with CRAs, CTAs, and centralized monitoring teams to ensure seamless project execution.

9. Provide Inputs to clinical study team and internal team members to manage continuous process improvements and take appropriate additional actions if no effect is observed.

10. Manage the operational insight of the assigned sites/studies and complete the study/site metrics trending (trend analysis of clinical aspects of the trial, share trends and agree on action plan, review, triage and action clinical study alerts, monitor clinical operation plan (COP) compliance etc.

11. Monitor site performance and make recommendations for timely corrective actions such as Site Telephone Contact or Triggered Onsite Monitoring Visits.

12. Provide study level administrative support to the clinical study management team such as running system reports, preparing and distributing status reports, creating and maintaining study trackers.

13. Execute delegated tasks from CMS leads with precision and accountability, contributing to overall study success.

1. Independently uploaded and organized clinical trial documentation into both electronic Trial Master File (eTMF) and intelligent Trial Master File (iTMF), ensuring thorough file reviews and compliance with regulatory standards.

Proficient in managing user access and access issues as well as performing access reconciliation across diverse study portals such as Medidata RAVE, Cenduit IRT, Clinical Trial Management System, Q2 Lab, ECG Connected Device, and Drug Dev ensuring secure, compliant, and role-appropriate system usage.

3.Successfully migrated essential documents from Accelsiors Document Access Management (ADAM) to i-ETMF, preserving data continuity and ensuring seamless system integration.

4. Maintained and updated site staff profiles within CTMS, contributing to accurate site-level data and streamlined trial operations.

5.Designed and managed detailed trackers to monitor SRTE (Site Ready to Enroll) status, monitoring visits, and subject visit schedules—enhancing visibility and operational efficiency.

6. Utilized Drug Dev (Learning Management System) to efficiently mark training as completed, ensuring accurate record-keeping, and streamlined progress monitoring.

7. Facilitated project onboarding by uploading e-Training materials for project team members to ELVIS, enabling smooth access for team members and promoting consistent training delivery.