Tatiana Midori Miyaoka Serrano
São Paulo,Brazil
Summary
Dedicated professional with a strong foundation in customer relationship building, ethical decision making, and emotional intelligence. Demonstrates a positive attitude and excels in active listening, negotiation techniques, and communication proficiency. Adept at critical-thinking and conflict resolution, consistently delivering effective solutions. Committed to leveraging these skills to foster productive work environments and drive organizational success.
Overview
17
17
years of professional experience
6044
6044
years of post-secondary education
Work history
Manager Clin Ops II
Fortrea (formerly Labcorp)
Sao Paulo, Brazil
2021.05 - 2025.01
- Ensures training record compliance with training matrix and ensures training records are up to date
- Provides input to relevant SOPs and standard plans/templates when applicable
- Assists with coordination and implementation of on-boarding of new direct reports ensuring required training completion before study-related activities begins
- Holds staff accountable for issue escalation to the management team, the sponsor and QA, as appropriate and determine regional implications for corrective action plans
- Performs weekly review of direct report billable hours and utilization (in context of project allocation, supply and demand); escalates of outliers and assists management team for mitigation
- Assists with staff recruitment through screening and interviewing
- Accountable for expense management, expense report approval and compliance with Travel Policy of direct reports
- Supports the company/department processes (e.g., Quality Control Visits)
- Responsible for staff time management, PTO and salary reviews
- All other duties as needed or assigned
Associate Manager Clin Ops
Labcorp Drug Development
Sao Paulo, Brazil
2019.10 - 2021.04
- Responsible for the supervision of assigned direct reports
- 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 communicated management strategies, policies and procedures in conjunction with leadership teams
- Developed and maintained effective relationships with management team to manage assigned staff in a matrix environment
- Maintained good working relationships with internal and external clients to ensure opportunity for acquiring additional new business
- Had regulatory oversight of direct reports by ensuring regulatory training was executed, understood and implemented
- Ensured training record compliance with training matrix and ensured training records were up to date
- Provided input to relevant SOPs and standard plans/templates when applicable
- Assisted with coordination and implementation of on-boarding of new direct reports ensuring training before study-related activities begun
Senior Clinical Research Associate
Covance
Sao Paulo, Brazil
2016.04 - 2019.09
- Planned and managed study milestones at site level in order to achieve sites activation, recruitment target, database lock and site closure
- Developed study-specific monitoring tools
- Conducted pre-study, initiation, monitoring, and close-out visits according to SOPs and GCP
- Served as Lead CRA, acting as the primary contact for all monitoring-related questions for the monitoring team
- Acted as resource and facilitate training for new CRAs
Clinical Research Associate IV
Medpace
Sao Paulo, Brazil
2011.11 - 2016.03
- Conducted pre-study, initiation, monitoring, and close-out visits according to SOPs and GCP
- Responsible for overall site management for assigned sites including written and verbal communication and scheduling of monitoring visits
- Responsible for completion of visit reports and maintenance of study-related databases
Clinical Research Associate
ECLA Brasil
Sao Paulo, Brazil
2011.01 - 2011.10
- Managed sites and performed on-site monitoring activities
- Identified and recruited investigators
- Performed remote monitoring activities
- Assisted Investigator meetings including preparation, presentations, problem resolutions and follow-up
- Ensured timely submission of protocol and consent documents for EC and IRB approval
- Maintained all files and documentation pertaining to studies
- Performed administrative duties including attendance at clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions
- Translated study documents
- Maintained knowledge of all assigned monitoring responsibilities, GCP and ICH guidelines, and their associated work instructions
- Contacted Principle Investigators and all involved staff in the sites
Clinical Research Assistant
Instituto Dante Pazzanese de Cardiologia
Sao Paulo, Brazil
2008.02 - 2010.12
- Made site selections and responsible for study start-up
- Adhered to study protocol, monitoring responsibilities, and regulatory requirements
- Conducted on-site clinical monitoring including document review, ensuring accurate data recording, verifying patient data, and adherence to GCP and ICH guidelines and Sponsor SOPs
- Performed source data verification, query resolution, drug accountability, and site safety
- Ensured correct storage of drugs and diligent account of all drugs
- Responded to CRF queries
- Completed study close-out activities
Education
Masters of Business Administration -
Fundação Getulio Vargas (FGV)
Sao Paulo Master - Public Health
University of Sao Paulo (USP)
Bachelors - Physiotherapy
Paulista State University (UNESP)
Skills
- Customer relationship building
- Ethical decision making
- Emotional intelligence
- Positive attitude
- Active listening
- Negotiation techniques
- Communication proficiency
- Critical-thinking
- Conflict Resolution
Languages
Portuguese
English
Custom
- GCP Training in a yearly basis
- Residence Program in Cardiovascular Functional Physiotherapy, 02/01/08
- Professional Formation in Clinical Research, 06/01/08
Personal Information
- Age: 40
- Marital status: Married
Timeline
Manager Clin Ops II
Fortrea (formerly Labcorp)
2021.05 - 2025.01
Associate Manager Clin Ops
Labcorp Drug Development
2019.10 - 2021.04
Senior Clinical Research Associate
Covance
2016.04 - 2019.09
Clinical Research Associate IV
Medpace
2011.11 - 2016.03
Clinical Research Associate
ECLA Brasil
2011.01 - 2011.10
Clinical Research Assistant
Instituto Dante Pazzanese de Cardiologia
2008.02 - 2010.12
Masters of Business Administration -
Fundação Getulio Vargas (FGV)
Master - Public Health
University of Sao Paulo (USP)
Bachelors - Physiotherapy
Paulista State University (UNESP)