Aline Alexandre
Sr CRA | CRA Lead | Mentor & Trainer
Marly la Ville
Profil professionnel
Clinical Research professional with 11+ years of experience across academic institutions, CROs and pharmaceutical companies. Strong expertise in oncology and Phase I–IV clinical trials. Experienced as CRA Lead, mentor and trainer, supporting onboarding, qualification and development of new CRA. Recognized for quality initiatives, audit preparation, sponsor collaboration and cross-functional leadership. Looking to further develop leadership responsibilities within clinical research.
Vue d'ensemble
9
9
years of professional experience
Expérience
Senior Clinical Research Associate II
Syneos Health FSP Bristol Myers Squibb (BMS)
2024.09 - Actuel
- Lead CRA on oncology studies.
- Monitored Phase I–III oncology from selection visit through close-out.
- Primary sponsor interface for study conduct, issue resolution and operational updates.
- Manage investigational sites across France, including monitoring, site support and study oversight.
- Mentor and support new CRA through onboarding, training and ongoing development.
- Collaborate with cross-functional teams (CTM, Data Management...)
Senior Clinical Research Associate I
PPD
2023.05 - 2024.08
- Managed site initiation, monitoring and close-out activities.
- Primary contact for investigative sites and sponsor representatives.
- Ensured protocol compliance, data quality and patient safety.
- Supported onboarding and mentoring of new CRA team members.
- Participated in the qualification and development of newly hired CRA through coaching, joint monitoring visits, performance assessment and feedback to management to support independent monitoring authorization.
Senior Clinical Research Associate I
PPD FSP GlaxoSmithKline (GSK)
2020.09 - 2023.05
- Monitored Phase I–III oncology and infectious disease studies from selection visit through close-out.
- Led follow-up items initiative, tracking quality and operational action items and presenting monthly progress updates during team meetings.
- Lead CRA on multiple oncology studies
- Oncology Referent for newly hired CRA, providing training, guidance and support on oncology studies and processes
- Contribute to quality initiatives, audit preparation and inspection readiness.
- Supported training and integration of newly hired CRA.
- Participated in the qualification and development of newly hired CRA through coaching, joint monitoring visits, performance assessment and feedback to management to support independent monitoring authorization.
Clinical Research Associate II
IQVIA
2019.09 - 2020.08
- Conducted monitoring activities for oncology and rare disease clinical trials.
- Performed site initiation, monitoring and close-out visits.
- Maintained strong relationships with investigators and study coordinators.
- Ensured data integrity and protocol compliance.
Clinical Research Associate II
PPD
2017.09 - 2019.08
- Monitored international Phase II–III clinical trials.
- Managed investigative sites and supported study execution.
- Ensured compliance with protocol requirements and regulatory standards.
- Contributed to high-quality data collection and study delivery.
Study Coordinator
Institut Curie, Paris
2015.09 - 2017.08
- Phase I–IV Oncology Studies.
- Coordinated interventional and observational oncology clinical trials.
- Managed patient visits, study documentation and source data collection.
- Collaborated with investigators, sponsors and multidisciplinary teams.
Formation
M.Sc. Clinical Research Coordinator, 2015
Versailles Saint Quentin en Yvelines UniversityM.Sc., Biology, 2014
Paris Est Créteil University, FranceB.Sc. Biology, 2013
Paris Est Créteil University, FranceCompétences
- Leadership & Communication
- People Development
- Stakeholder Management
- Problem Solving
- Cross-Functional Collaboration
- Decision Making
- Organizational Skills
KEY AREAS OF EXPERTISE
- CRA Lead
- CRA Mentoring & Coaching
- Oncology Referent
- CRA Qualification Visits
- Sponsor Collaboration
- Audit Preparation
- Quality Initiatives
- Inspection Readiness
Langues
Portugais
Bilingue
Anglais
Opérationnel
Chronologie
Senior Clinical Research Associate II
Syneos Health FSP Bristol Myers Squibb (BMS)
2024.09 - Actuel
Senior Clinical Research Associate I
PPD
2023.05 - 2024.08
Senior Clinical Research Associate I
PPD FSP GlaxoSmithKline (GSK)
2020.09 - 2023.05
Clinical Research Associate II
IQVIA
2019.09 - 2020.08
Clinical Research Associate II
PPD
2017.09 - 2019.08
Study Coordinator
Institut Curie, Paris
2015.09 - 2017.08
M.Sc. Clinical Research Coordinator, 2015
M.Sc., Biology, 2014
B.Sc. Biology, 2013