Dušan Stefanović

- Performing Inspection Readiness Review for upcoming Study/TMF Audits by Internal/External Auditors

- Performing internal Personnel Quality Review for employees inside Records Management Compliance department

- Quality Check of TMF health for various studies and different phases of studies

- Supporting TMF Operations team members for upcoming audits

- Advising TMF Operations personnel on various topics on their's studies

-Perform RMC Lead Activities for 1-3 Studies.

-Support TMF set-up, coordinate ‘Requests for Sites to be added in eTMF’ between Project. Teams (PT) and eTMF administrators; review eTMF access and coordinate updates, as necessary.

-Maintain Sciforma resources and tasks up to date.

-Communicate directly with multiple Project Team members to assess project needs relevant to the TMF.

-Provide Subject Matter Expert (SME) support for Project Teams and Sponsor related to TMF.

-Oversee the QC process and makes sure the RMC is on track (compliant with timelines and documentation) and follow up on non-compliance accordingly.

-Prepare, maintain, and share TMF metrics and spreadsheets for assigned studies with Project Teams and Sponsors. Review TMF Key Performance Indicators (KPIs) and makes sure that TMF KPIs are in compliance.

-Follow-up, raise and escalate any TMF Quality issues and non-compliances in a timely manner to relevant parties.

-Support Regulatory and Sponsor audits and audits finding resolution, where necessary.

-Attend Internal and External Project Meetings and provide updates to Agenda and Minutes.

-Maintain the Study SharePoint for the Records Management Compliance related items and ensure documentation related to TMF Processes is filed accordingly.

-Organize TMF dedicated Meetings.

-Support the trainings organized by Records Management Compliance Training Team and act as a mentor to junior members of the team

-Assist in development of project specific TMF Quality Management Documents

-Support TMF Final Reconciliation and generation of Final List of queries

-Support communication with Study Team and Sponsor related to TMF Final Reconciliation and TMF Closure and Return

-Fulfil the "TMF Approver" and/or "TMF QC Reviewer" roles as defined by the relevant Standard Operation Procedure(s) (SOP) and working practices.

-Process, review, and resolve rejected Trial Master File (TMF) documents, for complex studies or Sponsor portfolio of studies both in an electronic and hard copy format.

-Prepare periodic TMF Quality Control checklists for review by Project Team review.

-Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices.

-Work with a variety of Electronic Document Management and electronic TMF Systems to review, classify and process Essential Documents.

-Communicate directly with RMC Lead to report trends and issues relevant to the TMF.

-Escalate any TMF Quality issues in a timely manner to RMC Lead.

-Deputize for RMC Lead where required.

-Provide administrative support for the RMC Lead including but not limited to filing and maintaining internal documents on study SharePoint (TMF Quality Control checklists and different trackers).