• Fully accountable for the success of project start-up• Efficiently manage and successfully execute all aspects of global start-up according to Sponsor specifications, including maintaining start-up timelines• Independently interact with Sponsor, sites, IRB/ECs, regulatory agencies and Medpace team• Provide submission advice and guidance to Medpace team to ensure compliance with appropriate regulations and requirements• Prepare project/country-specific Informed Consent templates and negotiate/review content changes from sites• Provide oversight of Clinical Trial Submissions Coordinators and Project Assistants• Review pertinent regulations and guidances to develop proactive solutions to regulatory issues and challenges• Maintain ongoing Sponsor contact for submission issues by serving as primary contact for Sponsor and project team members• Provide regulatory submissions advice and guidance to the team to ensure compliance with appropriate regulations and requirements• Present during bid defenses, general capabilities meetings, and audits

• Serve as primary contact with the sponsor, study PM and other functions and third parties;• Attend study related meeting and calls for all assigned studies;• Provide support to regional staff when required to ensure all tasks are carried out according to ICH-GCP and agreed SOP's;• Knowledge and experience in the clinical study start up requirements and activities for all assigned countries;• VHP experience;• Pediatric experience;• SIC/ICF EU Master population/review and country SIC/ICF adaptation;• Training of new Study Start Up colleagues and Clinical employees (Spain and Portugal);

• Distribute, track, review, and approve individual site Trial Master File (TMF) essential documentation at project start;• Collect, review, organize, and assemble regulatory start-up submissions;• Maintain timelines for regulatory submissions and site start-up;• Provide advice and guidance to internal and external team members to ensure compliance with applicable regulations and requirements;• Review pertinent regulations and guidances to develop proactive solutions to regulatory submissions issues and challenges;• Utilize and assist in maintaining (Essential Documents module);• Track submissions and ensure timely filing of documents.• Work with Document Center to ensure necessary documentation is present; and• Train and assist Clinical Research Associates on collection of essential documentation for on-going phase of project. Review documentation submitted by Clinical Research• Associates and forward to client.

• Iberian regulatory requirements collation• SIS/ICF EU Master population/review and country SIS/ICF adaptation – Portugal• Preparation of EU Application Form (Core and country specific)• Regular contact with the designated personnel from Regulatory Authorities & Ethics Committees must be maintained in order to monitor the submission progress in accordance with study start up deadlines.• Preparation of EC and CA submission (Portugal) • Review and translate Drug Labels and advise Sponsor on knowledge content for development of Drug Labels• Negotiating site level contracts to ensure sites are activated within the agreed timelines.

• Preparation as assistant the Portuguese and Spanish submissions- Regulatory Department.Main functions:• Request of translation of documents needed for Submission;• Follow up the delivery of translation/TRFs;• Request, process and follow-up of EC/CA fees;• Arrange couriers• Preparation of submission packages;• Translation/Revision of documents;• Follow-up AoRs of all documentation submitted;• Distribution of original documents to study CRA/CTA /Global CTA;• EC/CA requirements update;• Arrange meetings;• Process Couriers/translations/stationery vendors invoices; • Daily Contact with Finance Department.