Ludovic PAYNOT
Clinical Project Manager
Nantes
Profil professionnel
Clinical Project Manager with 20+ years of experience in CRO settings, leading international clinical trials from feasibility through close-out. Proven country/site operational oversight, coordination of cross-functional teams (CRAs/CTCs, PV, Regulatory), milestone management, ICH-GCP compliance, and inspection readiness. Strong oncology experience (Phase I-III) and solid expertise with eTMF/EDC environments. With 5+ years of experience as a Clinical Research Manager, I specialize in study delivery and risk management. Motivated to contribute to healthcare innovation, I am seeking a role where my leadership and collaborative skills can drive high-quality execution. Clinical Research Manager with extensive experience in clinical trial management, ensuring ICH-GCP and regulatory compliance. Expertise in operational delivery, risk management, and coordination of multidisciplinary teams.
Vue d'ensemble
21
21
years of professional experience
1
1
year of post-secondary education
1
1
Certification
Expérience
Clinical Research Manager
Fortrea
Paris
2020.09 - 2026.06
- Lead country-level study execution (start-up, conduct, close-out), ensuring compliance with ICH-GCP and applicable local regulations.
- Serve as the country/protocol point of contact: track milestones, deliverables, and KPIs; proactively manage risks, issues, and escalations.
- Coordinate internal and external stakeholders (Country/Regional Ops, PV, Regulatory, Medical, vendors, investigators) to align on key decisions (study allocation, recruitment plans, priorities).
- Line-manage and coach field teams (CRAs/CTCs): ensure training compliance, review monitoring visit reports, perform quality oversight visits, and implement remediation plans as needed.
- Support country-level budget and contract tracking per delegation (resource forecasting; input to budgets/contracts) and maintain the client relationship at country level.
- Conduct country feasibility assessments and respond to RFIs (site capacity, timelines, operational constraints) to support successful study delivery.
Site Oversight Lead
Excelya
Paris
2019.07 - 2020.09
- Ensure overall site quality: monitor regulatory and ICH-GCP compliance and support sites on protocol requirements.
- Oversee completeness and quality of study deliverables (documentation, eTMF) and contribute to inspection and audit readiness.
- Partner with Operations and Quality to identify site-level risks and implement CAPA plans (corrective and preventive actions).
- Prioritize workload to meet quality expectations and timeline commitments.
- Foster team collaboration through clear communication and shared ownership.
Clinical Operations Lead
PAREXEL International
Paris
2013.10 - 2019.07
- Coordinate study start-up, conduct, and close-out: drive action plans, priorities, and communication within the project team.
- Lead monitoring teams (CRAs): resource allocation, performance management, technical support, capability building, and inspection readiness.
- Provide operational reporting (progress, risks, deviations, corrective actions) to management and key project stakeholders.
- Drive continuous improvement (process and quality) and manage site/investigator-related escalations.
- Prioritize workload to meet quality expectations and timeline commitments.
- Foster team collaboration through clear communication and shared ownership.
CRA 3 (Lead CRA)
PAREXEL International
Paris
2008.05 - 2013.10
- Manage and monitor various international studies: initiation, routine, and close-out visits; deviation management; data quality; and safety oversight.
- Partner with sites and investigators to optimize recruitment, maintain protocol compliance, and drive timely query resolution.
- Contribute to eTMF maintenance and on-time reporting, with proactive risk identification and escalation.
- Prioritize workload to meet quality expectations and timeline commitments.
- Foster team collaboration through clear communication and shared ownership.
CRA 2
ClinicalLand
Paris
2006.02 - 2008.05
- Monitor and manage site operations for national studies: ICH-GCP compliance, data quality, and follow-up of site action items.
- Prioritize workload to meet quality expectations and timeline commitments.
- Foster team collaboration through clear communication and shared ownership.
CRA 1
ORION Clinical Services Ltd
Paris
2005.01 - 2006.01
- Monitor national and international clinical trials; support feasibility activities and site selection.
- Prioritize workload to meet quality expectations and timeline commitments.
- Foster team collaboration through clear communication and shared ownership.
Formation
Master of Science (MSc) - Biotechnologies, human physiopathology, pharmacology & clinical research
Nantes University
Nantes, France 2004.09 - 2005.06
Master of Science (MSc) - Molecular & Cellular Biology
Tours University
Tours, France 2002.09 - 2003.06
Compétences
- End-to-end operational management of clinical trials
- Quality & compliance (ICH-GCP)
- Inspection readiness
- Cross-functional and cross-country stakeholder management
- Clinical trial oversight and monitoring strategy
- Leadership of multidisciplinary clinical teams
- Proactive problem-solving and decision-making
- Clear, effective communication with internal and external stakeholders
- Critical thinking and analytical mindset
- Strong organization and rigorous execution
- Agile ways of working
- Pilotage opérationnel d'essais cliniques
- Qualité & conformité, ICH-GCP
- Inspection readiness
- Collaboration transverse
- Gestion des risques en recherche
- Surveillance des essais cliniques
- Leadership d'équipes multidisciplinaires
- Résolution proactive des problèmes
- Communication efficace interne et externe
- Esprit critique et analyse
- Organisation rigoureuse
- Méthodologie agile
Certificats
GCP Training & Assessment, Barnett International, 2024-01-01
Langues
French
Bilingue
English
Courant
Hobbies
- Cinema and photography enthusiast
- Rowing: active club member for 2 years
- Travel: USA, Canada, and European capitals
- Certified first aider
- Volunteer, Protection Civile 44
Chronologie
Clinical Research Manager
Fortrea
2020.09 - 2026.06
Site Oversight Lead
Excelya
2019.07 - 2020.09
Clinical Operations Lead
PAREXEL International
2013.10 - 2019.07
CRA 3 (Lead CRA)
PAREXEL International
2008.05 - 2013.10
CRA 2
ClinicalLand
2006.02 - 2008.05
CRA 1
ORION Clinical Services Ltd
2005.01 - 2006.01
Master of Science (MSc) - Biotechnologies, human physiopathology, pharmacology & clinical research
Nantes University
2004.09 - 2005.06
Master of Science (MSc) - Molecular & Cellular Biology
Tours University
2002.09 - 2003.06