Silvia Perdomini. Email & Phone Number

Argentina

Emma De La Barra 353 Piso 5, Caba

Fortrea SA, Buenos Aires, Argentina – Sept 2019 – Dec 2023Start-Up Associate, Start-Up Operations – *Trial and site administration:o Track (essential documents) and report (Safety Reports)o Ensure collation and distribution of study tools and documentso Update clinical trial databases (CTMS) and trackerso Clinical supply & non-clinical supply management, in collaboration with other country roleso Manage Labeling requirements and coordinate/sign translation change request• Document management:o Collate, distribute/ship, and archive clinical documents, e.g. eTMFo Update manuals/documents (e.g., patient diaries, instructions)o Prepare Investigator trial file• Regulatory & Site Start-Up responsibilities: o provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissionso Obtain, track and update study insurance certificateso Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.• Budgeting, Agreement and Payments:o Develop, control, update and close-out country and site budgets o Develop, negotiate, approve and maintain contracts (CTRAs)o Track and report contract negotiationso Update contract templates (in cooperation with Legal Department)o Calculate and execute payments(grants)o Ensure adherence to financial and compliance procedures●Start-Up Associate, Start-Up Operations Oct 2017-Sept 2019 Regulatory & Site Start-Up responsibilities:Preparation, review and coordination of local regulatory submissions to various entities in alignment with global submission strategy and standard operating procedures and in accordance to target cycle times set up. Set-up and maintenance of project files (electronic and hardcopy). Participation in team meetings (in English). Administrative support to the team. Coordination of translations and payments. Ensure that trial status information are accurately maintained in the database and is current at all times

Provincia De Buenos Aires, Argentina

Maipu Y Sarmiento, Caba, Argentina

Telemarketer, working under contract with Laboratory AbbVie – Apr 2017 – Jun 2017• Follow up to patients in treatment with Adalimumab (Humira)• Report of Adverse events to PVG (Lab. AbbVie)• Update CRM (Oracle)

Site Intelligence & Activation (Contract Coordinator) PPD Argentina SA.Jan 2006 – Aug 2016Site Intelligence & Activation- (SIA Contract Coordinator) – Jan 2006 – Aug 2016Site Intelligence & Activation- (SIA Contract Coordinator) – Jan 2006 – Aug 2016• • Establish and maintain all project documentation including all files, records and reports according to the scope of work and SOPS.• Conduct periodic review/audit of files for accuracy and completeness.• Coordinate and track all information, communications, documents, materials and supplies for assigned projects across the region.• Update and maintain internal systems, databases, tracking tools, timelines and project plans with project specific information. Act as internal primary contact for project systems and tools.• Assist the CPM/CTL in the communication with the Clinical Team(CRAs/CTAs/ CRAs/CRSs/RSU)• Prepare and monitor of Clinical Trial Agreements from initial site contact through execution of agreements (the “CTA Process”).• I was assigned to work and negotiate the CTA Amendment form the beginning until the end (execution) for LA countries (except Brazil) and send all bank information of each contract or amendment to proceed with the payments

Licenciatura, Seguridad Indiustrial

Tecnico En Seguridad E Higiene, Homeland Security, Law Enforcement, Firefighting And Related Protective Services, 7.92