Mariana Spitaletti
Summary
Clinical Operations Manager with more than 16 years of Clinical Strong background in CRO environment, with recognized leadership skills with focus on developing Clinical Research Associates (traveling and in-house CRAs) and building motivated, engaged and high-performing teams. An enthusiast of Clinical Research development in Brazil and Latin America. Result-drive leader without losing empathy, people development and motivation.
Overview
16
16
years of professional experience
Work History
Manager, Clinical Operations
Fortrea
São Paulo (Remote)
04.2021 - Current
- Accountable for performance and compliance for protocols in Brazil in compliance with ICH/GCP and country regulations, Client policies, procedures and quality standards;
- POC for assigned sponsors. Pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments. Forecasts country resource needs. Serves local business needs (signs contracts, manages budgets as delegated);
- Responsible for quality and compliance in Brazil Oversees CRAs and iHCRAs on assigned projects. Oversees training compliance. Performs quality control visits. Responsibilities include planning; assigning and directing work, assessing performance and guiding professional development of direct report.
- Responsible for collaboration with functional outsourcing vendors, investigators, other external partners. Oversees country and site validations, site selection and recruitment in the country;
- Responsible for appropriate management and resolution of performance issues;
- Effectively communicate management strategies, policies and procedures in conjunction with leadership teams;
- Develop and maintain effective relationships with management team to manage assigned staff in a matrix environment;
- Maintain good working relationships with internal and external clients to ensure opportunity for acquiring additional new business;
Associate Manager, Clinical Operations
Labcorp
São Paulo, Sao Paulo, Brazil (Remote)
03.2020 - 03.2021
- Responsible for the supervision of assigned direct reports within Clinical Operations, Flexible Solutions or Medical Device & Diagnostics;
- Responsible for detailed performance review and management of assigned direct reports including: Annual Performance Management and Development (PMD), Individual Development Plan (IDP);
- Responsible for appropriate management and resolution of performance issues;
- Effectively communicate management strategies, policies and procedures in conjunction with leadership teams;
- Develop and maintain effective relationships with management team to manage assigned staff in a matrix environment;
- Maintain good working relationships with internal and external clients to ensure opportunity for acquiring additional new business;
Clinical Team Lead
Labcorp/Covance
São Paulo, Sao Paulo, Brazil (Remote)
09.2019 - 02.2020
- Develop the strategy, plans, tools and training to oversee and assess performance of the clinical team, in the conduct and compliance of site visits (on site and remote), including, but not limited to: pre-study visits, site initiation visits, routine monitoring visit, motivational visits, close-out visits, audit support visits;
- Proactively communicate with CRAs and other members of the clinical operations team to follow up on all open issues, drive patient recruitment and retention, in order to meet the project timelines;
- Communicate effectively with all members of the project team and client as applicable, to support the study completion per company and client requirements and timelines, including risk identification and mitigation, issue escalation and working with Quality and the project team on Corrective and Preventative Actions;
- Fostered staff development and competency through supervision, coaching, trainings and team meetings.
- Contributed to financial health of organization by managing delivery of billable services.
Senior Clinical Research Associate
Labcorp/Covance
São Paulo, Sao Paulo, Brazil (Remote)
03.2016 - 08.2019
- Activities as Lead CRA: trip report reviewer, management of queries, financial project review (CRAs´ expenses), support for new CRAs;
- Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice;
- Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas;
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues;
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations;
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution;
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation;
- Perform administrative duties including attendance at clinical monitoring staff meetings, project team meetings, clinical committees, clinical training sessions etc., as required;
- Identify and record non-conformity with Company procedures and SOPs, and recommend and implement corrective and/or preventative action;
Contract Analyst
Quintiles
São Paulo, Sao Paulo, Brazil
05.2015 - 12.2015
- Revise or develop the contracts and related budgets and scope of work. Ensure the scope of work is defined correctly and budgets reflect the scope. Ensure any changes are integrated into the main study contract efficiently and accurately;
- Represent Contracts team at customer meetings;
- Monitored incoming contracts and service agreements for correct pricing and information.
Senior Clinical Research Associate
Quintiles
São Paulo, Sao Paulo, Brazil (Remote)
01.2011 - 04.2015
- Activities as Lead CRA: trip report reviewer, management of SAEs, management of queries, financial project review, act as a mentor for new CRAs in CRAs Mentoring Program;
- Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice;
- Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas;
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues;
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations;
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution;
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation;
- Perform administrative duties including attendance at clinical monitoring staff meetings, project team meetings, clinical committees, clinical training sessions etc., as required;
- Identify and record non-conformity with Company procedures and SOPs, and recommend and implement corrective and/or preventative action;
Clinical Research Associate II
Sanofi
São Paulo, Sao Paulo, Brazil
09.2009 - 11.2009
- Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice;
- Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas;
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues;
Clinical Research Associate II
Quintiles
São Paulo, Sao Paulo, Brazil (Remote)
01.2008 - 04.2009
- Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice;
- Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas;
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues;
Education
Bachelor of Science - Pharmaceutical Industry
Faculdades Oswaldo Cruz
Sao Paulo, BrazilMBA - Project Management
FIA Business School
São Paulo, Sao Paulo, Brazil12.2019
Skills
- Team Leadership
- Verbal and written communication
- Complex Problem-Solving
- Staff Training and Development
- Strategic Planning
Languages
Portuguese
Bilingual or Proficient (C2)
English
Advanced (C1)
Spanish
Beginner (A1)
Timeline
Manager, Clinical Operations
Fortrea
04.2021 - Current
Associate Manager, Clinical Operations
Labcorp
03.2020 - 03.2021
Clinical Team Lead
Labcorp/Covance
09.2019 - 02.2020
Senior Clinical Research Associate
Labcorp/Covance
03.2016 - 08.2019
Contract Analyst
Quintiles
05.2015 - 12.2015
Senior Clinical Research Associate
Quintiles
01.2011 - 04.2015
Clinical Research Associate II
Sanofi
09.2009 - 11.2009
Clinical Research Associate II
Quintiles
01.2008 - 04.2009
Bachelor of Science - Pharmaceutical Industry
Faculdades Oswaldo Cruz
MBA - Project Management
FIA Business School