Renata Anaz

Responsible for multiple studies over different therapeutic areas. The activities as a Sr. Clinical Team Manager have spanned from start up to close-out. Experience includes leading the identification and selection of sites and vendors, planning and management of study/site budget and site’s clinical trial agreements, visit reports review, risk management overview and general study planning;

Developed and implemented strategies that improved patient recruitment;

Implement QC activities, ensure compliance with quality measures, and monitor required quality metrics;

Responsible for the development and maintenance of operational plans e.g. for clinical deliverables CRF completion guideline, Monitoring Plan, Recruitment Plan, Clinical Training plan, annotated trip report;

Ensure timely dissemination of information on study progress or issues and/or processes to all team members related to clinical deliverables and accurate tracking of any relevant study information related to clinical deliverables;

Active involvement in clinical risk planning and assessment, developing mitigation strategies and associated action plans, issue escalation and resolution;

Primary point of contact for the clinical aspects of designated projects and responsible for developing successful cross-functional relationships with internal and external stakeholders;

Responsible for planning, scheduling and implementing the clinical aspects of projects in line with contract and budget, e.g. implementation of protocol and amendments; protocol deviation prevention, tracking and reporting; lP management, timely investigator payments.

Responsible for multiple studies over different therapeutic areas. The activities as a Clinical Team Manager have spanned from start up to close-out;

Leads clinical study team meeting; present at intra-/inter- departmental and external meeting;

Created, maintains and collaborates on applicable project documents, plan, templates and tools;

Communicates effectively with sponsor, project manager, functional team leads and other project team members;

Recognizes potential risks within the study protocol and operational aspects of the trial; serves as the primary liaison for clinical monitoring site risks and issues; proactively establishes contingency and mitigation plans;

Collaborates with a cross functional group of site monitors, site managers, biometrics team members to achieve successful delivery of data.

Experience includes leadi.ng the identification (feasibility) and selection of sites, planning and management of study/site budget and site’s clinical trial agreements organization/collection of data/material necessary for initiation visits, responsible to reach the recruitment timelines, visit reports review, risk management overview and general study planning. Participation in some local/global groups to improve company´s procedures and align all countries of America as a unique region

Responsible for multiple studies over different therapeutic areas. The activities as a Clinical Team Manager have spanned from start up to close-out. Experience includes leading the identification and selection of sites, planning and management of study/site budget and site’s clinical trial agreements, visit reports review, risk management overview and general study planning. Acting as the primary contact for importation of investigational product as well as management of the shipments to the sites and post study access. Participation in MoH inspection as CTM.

Site selection, interim monitoring and close-out visits, responsible for multiple sites, payments, managing ongoing project expectations, issues and deviations. Participation in global teleconferences. Mentoring of new PAs and CRAs.Participation in sponsor´s audits.

Initiation, interim monitoring and close-out visits, responsible for multiple sites, revision site budget and payments, continuous training of site staff on protocol, IP preparation of intravenous IP and GCP refreshment, managing ongoing project expectations, issues and deviations. Experience in unblinding monitoring activities, purchase and finance control of supportive medications and devices for all Brazilian sites, managing IP shipment, return and destruction, track of deviations and control/resolution of product excursions for all Latin America sites. Coaching/training of new PAs and CRAs, preparation of tools, presentations and materials to help all team.

Interim monitoring and close-out visits, resolved queries, create monitoring tools for the team and tools for the site, interacting with assigned contact in PPD and Sponsor QA to ensure project compliance with ICH GCP/FDA CFR, performed partial and final drug accountability, ensured prompt reporting of adverse events; participation in two audits, data base locks, final data transfers, weekly conferences and prepare audit files at Pfizer and site.

Performed all regulatory process issues and supported sites during the study start up, performed in house CRF and Protocol review, initiation, interim monitoring visits. Performed interim monitoring visits according to applicable Standard Operating Procedures (SOPs), FDA and ICH guidelines; reviewed source documents and case report forms to find new adverse events not previously reported. Created monitoring tools for the team and participated in data clean transfer. Latin America Investigator’s Meetings participation.

Prepared, organized and sent the necessary documentation for the submission to the Ethics Committee in Research (IRB), filled CRF, ISF archive maintenance, followed the subjects visits and dug accountability; dispensed study drug to study subjects.