Rupa Sravani Yakkala

TMF Filing

• Assist with upload of electronic documents to SMF within SOP / Project specified timelines
• Complete document indexing.
• Perform pre-QC to ensure documents are correct and complete, as per the ALCOAC principle.
• Submit documents for QC.
• Address any reworks from QC and file reviews.
• Track essential documents in CTMS, if assigned.

TMF - Document Specialist (QC)

• Perform QC and finalize study documents as per SOP, project specific timelines, and instructions.
• Raise reworks for incorrect documents.
• Complete any pending indexing or reworks, if assigned.

TMF - File Reviewer

• Perform file reviews of assigned studies as per SOP, project specific timelines, and instructions.
• Conduct file review kick-off and closeout meetings.
• Create Action Items.
• Review Action Items resolution to close or reopen Action Items, as appropriate.
• Initiate file review report for sign-off, and publish file review report in SMF.

TMF Analyst

• Assist with study and country-level wizard execution (execute wizards within the system).
• Assist with ServiceNow tickets for WS access (Grant/Revoke access, work area request, Execute or Run wizard/event, etc.).

Work Management Lead

• Responsible for managing the flow of work within the RWE support mailbox.
• Responsible for assigning emails and EDPs received within the RWE Support mailbox to SMA for processing.
• Responsible to delegate documents in Wingspan or ensure documents are acquired in i-TMF by the Document Specialists for processing.
• Responsible to follow up with the SMA to ensure documents are processed as per SOP, Project Specific Instructions, and timelines.
• Assist as SMA in times of need (i.e., during high influx of document filing, etc.).

Site ID

• eSIF Programming, Site List Cleaning to ensure site details are available for site creation in CTMS.
• CTMS updates for Site Creation, this includes creation of PI Contact and Account, as well as ensuring that Sites are promoted to the correct protocol and country.
• Creation of folders in SharePoint. Customization of CDA's and email templates, including sending the initial invitation email to sites, the SIF email, and selection/declination emails in accordance with Site ID Guidelines.
• Creating Assistance Requests and tracking activities, as well as SID Document Tracking in CTMS.
• Uploading of SIFs and CDAs for assigned projects in their appropriate locations.

ISF Activity

• Coordinate with the project team for purchase order creation in COUPA.
• Coordinate with the vendor for ISF binders printing and shipment to sites before SIV.
• Prepare ISF proof as directed by the project team.

• To ensure compliance with ICH GCP while conducting the study.
• Collaborating with CRA, PI, Subject, and other team members to ensure the study is conducted in accordance with the protocol within defined timelines and safety.
• Internal monitoring of study files at the SMO prior to the monitoring visits.
• Maintaining accountability of study supplies, drugs, shipments, etc.
• Verifying that storage conditions, receipt, use, and return of investigational products at the site are controlled and documented adequately.
• Assisting CRAs during monitoring visits and closeout.
• Maintenance of source documents and ensuring the ISF is audit-ready.
• CRF data entry.
• Coordinating in ethics committee submissions, notifying EC of deviations.
• Generating study invoice.
• Follow-up communications with subjects.
• To liaise with other departments within the organization for timely achievement of the scheduled subject visits.
• Coordinate with third parties, e.g., couriers, labs.
• To maintain effective communication.
• Acknowledge safety notifications received on portals, preparation of EC submissions CIOMS, SUSARs, PUSRs.
• Supervision of drug administration, AE monitoring, sampling, safety assessments for smooth conduct of the study as per protocol, SOPs, and GCP.