Sandrine Verstraete
Independent Clinical Research Professional
Experience
Independent Clinical Research Professional
ClinARC
- Provided consultancy and operational leadership to global pharma and CROs.
- Roche (2001–Present): EU CTR Business Process Owner (active); Veeva SSU module part of the global implementation SME team (active); delivering ICH/GCP (R2&R3) training (active); Global SIP Adoption Lead (inactive); People Leader (inactive); Regional Study Manager (inactive); Country Study Manager (inactive); Therapeutic Area Lead for non-oncology trials in Belgium (non-active)
- AMS (2022–Present): CRA for Parkinson disease clinical trial
- Novellas (2017–2019) and ClinOpsHub (2025–Present): ICH GCP trainer for sponsors and investigators
- Brunel (2012–2015): CRA training and onboarding for junior CRAs
- AbbVie, Biogen, Sanofi, Novo Nordisk and Ferring (2001–2013): Clinical Operations roles
- Clinical Trial Regulation (CTR): Successfully co-led the transition of 125+ clinical trials, consistently delivered ahead of regulatory deadlines
- Process excellence: Designed and implemented a robust CTR submission and post-approval framework, ensuring compliance and operational efficiency across both in-house and outsourced study teams
- Site Investigator Portal (SIP): Directed the onboarding of 1,000+ investigators worldwide, driving global adoption of SIP functionalities and strengthening affiliate engagement
- Training and development: Delivered ICH/GCP training programs to sponsors and investigators, achieving consistently high participant satisfaction and feedback scores
- Leadership agility: Recognized for the ability to rapidly integrate into new roles and environments, leveraging extensive experience to provide immediate operational value
Clinical Research Associate
Omnicare Clinical Research
- Managed site monitoring, submissions and investigator feasibility
- Built early expertise in clinical trial operations and GCP compliance
Material Management Officer
Hoechst Marion Roussel
- Served as intermediary between Hoechst AG and Belgian drug purchasers and oversaw company fleet (140 cars) and procurement operations
Industries Experience
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Experienced in Pharmaceutical (30 years), Biotechnology (25 years), and Healthcare (25 years).
Business Areas Experience
The graph below provides a cumulative view of the freelancer's experience across multiple business areas, calculated from completed and active engagements. It highlights the areas where the freelancer has most frequently contributed to planning, execution, and delivery of business outcomes.
Experienced in Quality Assurance (28 years), Research and Development (28 years), Project Management (25 years), Logistics (3 years), and Procurement (3 years).
Summary
Senior Clinical Operations Leader with 25+ years of experience driving regional and country trials across multiple therapeutic areas. Proven track record implementing EU CTR processes, building and managing high-performing teams of 90+ professionals and leading SIP adoption worldwide. Combining strategic leadership and operational expertise with a psychology background to deliver sustainable success in complex, matrixed environments. I thrive on complex challenges and bring passion, resilience, and strategic leadership to deliver sustainable success in matrixed, multinational environments.
Skills
- Global, Regional & Local Clinical Operations Leadership
- Ema Ctr Sme
- Ich/gcp (R3) Certified Trainer & Audit Compliance
- Systems Knowledge: Siebel Ctms, Veeva Ctms, Rave, Clincase, Sip, Google Suite, Veeva Ssu Module (Part Of The Global Implementation Sme)
Languages
Education
KU Leuven
Master in Fundamental & Industrial Psychology · Fundamental & Industrial Psychology · Leuven, Belgium
KU Leuven
Candidatures in Psychology · Psychology · Leuven, Belgium
OLV ter Engelen Lyceum
Mathematics/Economics · Kortrijk, Belgium
Certifications & licenses
ICH/GCP (R3) Certified Trainer & Audit Compliance
Profile
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