• Acts as main operational support to entire study team• Organises project team and client meetings including scheduling, meeting materials, agendas and meeting minutes.• Creates index for site and pharmacy binders, coordinates and overviews set-up and distribution of study binders and study tools to sites. • Assists in EU-CTR transition and liaises with sites and collects documents for new CTIS submissions. Customises and redacts documents as per requirements and maintains submission tracker.• Overviews and maintains repository for document upload and transfer to TMF, performs QC and follows up with document owners on discrepancies.• Thorough understanding of TMF (Veeva Vault), assists with filing core, country and site documents and acts as point of contact.• Assists with organising face-to-face and virtual investigator meetings, acts as contact for vendor.• Liaises with sites during feasibility and collects CDAs and feasibility questionnaires• Reaches out to sites and assists CRAs in scheduling monitoring visits.• Accompanies CRAs on close-out-visits, reconciles the investigator site file and collects final documents for TMF. • Drafts and distributes newsletters and site communications.• Assists in preparing audits. • Was part of power user group during the implementation phase of a new CTMS system (Veeva Vault) and contributed to creating work instructions. • Created instructions and guidelines for onboarding new staff, assists with setting up client account (VDI).• Grants access to various systems and gives technical support.

Same duties as above

• Provided daily support to SALs• Subject Matter Expert for SSU related TMF questions• Created QC checklists and provided training to ensure TMF completeness and resolve quality issues• Support with submitting documents to the TMF, resolving queries and conducting QC in a timely manner

• Provided daily support to PMs/CTMs• Organized internal and external meetings, created agendas and took minutes• Provided regular study status updates to sponsor• Created and distributed newsletters and site communications• Responsible for coordinating and creating Appendix 16 for Clinical Study Report• Coordinated submissions / notifications with SSUAs during maintenance phase• Set up and maintained the Trial Master File including periodic QCs, follow-up on missing documents and resolve findings following sponsor QCs and audits• Assisted with creating TMF plan and QC tools• Coordinated and prepared final TMF deliverable to Sponsor and resolved/followed-up on final queries• Created Investigator Site Files and liased with SSU and Monitors for a timely delivery at site prior to SIV• Mentored new team members• Assisted with access requests and issues from team members and site users for various study systems• Distributed study tools and material to team members/sites• Updated the CTMS

• Provided daily support to PMs/CTMs• Organized internal and external meetings, created agendas and took minutes• Provided regular study status updates to sponsor• Created and distributed newsletters and site communications• Responsible for coordinating and creating Appendix 16 for Clinical Study Report• Coordinated submissions / notifications with SSUAs during maintenance phase• Set up and maintained the Trial Master File including periodic QCs, follow-up on missing documents and resolve findings following sponsor QCs and audits• Assisted with creating TMF plan and QC tools• Coordinated and prepared final TMF deliverable to Sponsor and resolved/followed-up on final queries• Created Investigator Site Files and liased with SSU and Monitors for a timely delivery at site prior to SIV• Mentored new team members• Assisted with access requests and issues from team members and site users for various study systems• Distributed study tools and material to team members/sites• Updated the CTMS

• Provided assistance to PMs/CTMs and CRAs• Maintained the Trial Master File and conducted periodic QCs, followed up on missing documents and resolved findings following sponsor QCs and audits• Provided recruitment status to sponsor• Took minutes• Translated study documents (submission letters, approvals, annual reports, contract clauses)• Updated the CTMS and provided access to team members• Distributed study tools and material to team members/sites

• Translated different study documents (submission letters, approvals, annual reports, contract clauses)• Set up and maintained investigator and in-house site files and gave support to CRAs• Updated the CTMS

Check-ins & check-outs, first point of contact for guestsProcessed bookings and requestsTranslated and updated the company’s website and booking documentsResponsible for requesting licenses required for vacation rentalsCoordinated cleaning schedule and repair and maintenance activities