SANDRA SCHEFLER
São Paulo,Brazil
Summary
Strategic and results-oriented Clinical Research Executive with 20+ years of leadership experience driving global clinical operations, portfolio governance, program delivery, and operational transformation across pharmaceutical, biotechnology, and CRO environments. Proven expertise managing Phase I–IV multicenter clinical trials across 15+ countries and overseeing studies involving 50+ investigational sites. Strong background in ICH-GCP, FDA, EMA, and ANVISA regulatory compliance, financial governance, vendor oversight, and executive stakeholder engagement. Recognized for improving operational scalability, strengthening sponsor partnerships, leading cross-functional global teams, and delivering high-impact clinical research programs within complex international environments.
Overview
24
24
years of professional experience
Work History
Portfolio & Strategy Director
IQVIA Biotech
São Paulo, Brazil
07.2021 - Current
- Lead global clinical portfolio operations supporting multinational biopharma and biotechnology clients across Phase I–IV clinical programs spanning 15+ countries and 50+ investigational sites.
- Direct financial governance activities including budgeting, forecasting, resource allocation, and capacity planning for complex international clinical operations.
- Develop executive KPI dashboards, governance reporting frameworks, and operational tracking systems to support strategic decision-making and portfolio visibility.
- Serve as executive liaison between sponsors, senior stakeholders, and operational teams while supporting RFP responses, bid defense presentations, and strategic account expansion initiatives.
Senior Director of Clinical Research Projects / Country Operations
Clinipace
Brazil
02.2007 - 07.2021
- Directed global clinical research programs across the Americas, Europe, and APAC regions supporting pharmaceutical and biotechnology sponsors in multiple therapeutic areas.
- Managed country-level operational performance, P&L accountability, regulatory compliance activities, and clinical infrastructure expansion initiatives within Brazil operations.
- Oversaw study startup activities including feasibility assessments, vendor qualification, investigator selection, regulatory submissions, and site activation processes.
- Led multidisciplinary teams across project management, clinical operations, regulatory affairs, and CRA functions while strengthening sponsor relationships through governance meetings and operational transparency.
Clinical Operations Coordinator (Lead CRA)
PRA Health Sciences
Brazil
07.2005 - 12.2006
- Coordinated international clinical studies ensuring alignment with sponsor objectives, regulatory standards, and ICH-GCP compliance requirements.
- Supervised CRA teams by managing workload distribution, study timelines, monitoring activities, and operational performance oversight.
- Partnered with pharmacovigilance, logistics, quality assurance, and regulatory teams to support seamless execution of clinical trial operations.
- Supported study documentation management, audit readiness preparation, issue escalation processes, and cross-functional communication across global teams.
Senior Clinical Research Associate
PPD
Brazil
06.2004 - 07.2005
- Executed site initiation, monitoring, and closeout activities for global oncology clinical programs across multiple research sites.
- Ensured compliance with clinical protocols, SOPs, ICH-GCP guidelines, and regulatory requirements throughout study execution.
- Supported site quality oversight, investigator communication, enrollment tracking, and monitoring visit documentation processes.
- Collaborated with internal operational teams to maintain trial timelines, resolve site issues, and support successful study delivery milestones.
Senior Clinical Research Associate
Intrials Clinical Research
Brazil
05.2002 - 06.2004
- Conducted clinical monitoring activities across multiple therapeutic areas with primary focus on oncology clinical studies.
- Managed Trial Master File documentation, regulatory records, and audit readiness activities supporting compliant clinical operations.
- Coordinated communication between investigators, research sites, sponsors, and internal operational teams to support enrollment and milestone achievement.
- Assisted with protocol implementation, site performance management, monitoring visit reporting, and issue resolution throughout study lifecycles.
Education
MBA - Project Management
Fundação Getulio Vargas
BrazilBachelor of Science - Pharmacy & Biochemistry
Faculdade Oswaldo Cruz
BrazilSkills
- Clinical Trial Management Systems (CTMS)
- Electronic Data Capture (EDC) Platforms
- Power BI
- KPI Dashboard Development
- Microsoft Project
- Advanced Microsoft Excel
- ERP Systems
- Clinical Documentation Management
- Resource & Capacity Planning Tools
- Financial Forecasting Systems
- Regulatory Submission Platforms
- Portfolio Governance Reporting
Languages
- English
- Spanish
- Portuguese, Native
- English, C2 Proficient
- Spanish, C1 Advanced
Regulatory Compliance Expertise
- ICH-GCP Compliance
- FDA Regulations
- EMA Guidelines
- ANVISA Compliance
- Audit Readiness
- Risk-Based Monitoring
- SOP Development & Compliance
- Clinical Trial Governance
Languages
Spanish
Beginner
A1
Timeline
Portfolio & Strategy Director
IQVIA Biotech
07.2021 - Current
Senior Director of Clinical Research Projects / Country Operations
Clinipace
02.2007 - 07.2021
Clinical Operations Coordinator (Lead CRA)
PRA Health Sciences
07.2005 - 12.2006
Senior Clinical Research Associate
PPD
06.2004 - 07.2005
Senior Clinical Research Associate
Intrials Clinical Research
05.2002 - 06.2004
MBA - Project Management
Fundação Getulio Vargas
Bachelor of Science - Pharmacy & Biochemistry
Faculdade Oswaldo Cruz