Description

Clinical Research & Scientific (PhD) Data Consultant specialized in hematology/oncology, Post-acute infection syndromes (PAISs), and real-world evidence.

I support sponsors, CROs and research teams with streamlined study operations, data cleaning/analysis, protocol review, and medical/scientific writing.

Former member of a Big Pharma Scientific Advisory Board, CRA/CRC in hematology, and ex-CERC (interventional cardiology) international monitor (FR/DE/AT/CH/UK).

I help teams move faster, reduce site burden, and improve data quality.

Langues

Anglais
Bilingue ou natif
Allemand
Capacité professionnelle limitée
Français
Bilingue ou natif

Préférences en matière de lieu de travail

Accepte de travailler sur site

Clermont-Ferrand (jusqu’à 50 km), Paris (jusqu’à 50 km), Lyon (jusqu’à 50 km)

MedKlar
Clinical Research & Evidence Generation Consultant (PhD)
INDUSTRIE PHARMACEUTIQUE
novembre 2022 - Aujourd'hui (3 ans et 7 mois)
Clermont-Ferrand, France
Providing flexible clinical research support to biotechs, CROs, and academic teams.

• Clinical Operations (remote CRA/CRC)
Site support, feasibility, documentation, monitoring for observational & non- interventional studies (hematology, rare diseases, internal medicine).

• Data & Evidence Generation
Data cleaning, QC listings, R/RMarkdown analyses, real-world evidence dashboards, multi-site databases (2,000+ patients).

• Scientific & Medical Writing
Protocols, statistical analysis plans, systematic reviews, publications. Scientific advisor for a Big Pharma-supported project (200 €/h).

• Focus areas
Long Covid, PAIS, Hematology, Interventional Cardiology, RWE design.

• Tools
R (tidyverse, ggplot2, lme4 and so on), REDCap, ENNOV, IBM, ICTA Rare diseases
GCP/ICH, GDPR, Excel advanced.

Delivering clear analyses, operational support, and publication-ready outputs.
Medical & Scientific Writing Recherche scientifique
CHU de Clermont-Ferrand
Clinical Research Associate
CENTRES DE RECHERCHE
décembre 2023 - novembre 2025 (1 an et 11 mois)
Clermont-Ferrand, France
Therapeutic area: Hematology & Oncology Key projects
Chronic Myeloid Leukemia (CML Observatory, NCT059630611):
• Monitoring and site activation across 20+ centers in France
• Local CRC for the coordinating site (Clermont-Ferrand)
• Member of the scientific committee and data manager for RWE-based initiatives
• Development of dashboards and analytic pipelines to support real-world
evidence studies

Aging & Biomarkers Study (Non-therapeutic):
• Oversight of data collection and clinical parameters related to biological vs. chronological aging

Gaucher Disease (Genzyme/Sanofi Registry):
• CRC for the national registry (mid-France region), ensuring protocol adherence and data quality

Niemann-Pick Disease (Olipudase Early Access Program):
• Site coordination and follow-up within the Sanofi compassionate use program

Highlights & contributions

Streamlined monitoring workflows and documentation processes using R and Excel automation
Strengthened collaboration between data science, clinical, and regulatory teams
Authored study reports and contributed to materials for national investigator meetings
Monitoring & Site Management (CRA/CRC) RWE / Evidence Synthesis Analyse de données Coordination transverse
CERC (Cardiovascular European Research Center)
International Clinical Research Associate
CENTRES DE RECHERCHE
novembre 2021 - octobre 2022 (11 mois)
Massy, France
International CRA for post-market and post-approval cardiovascular device trials across France, Germany, Austria, Switzerland, and the UK.

• Study start-up & activation
– Led site activation and monitoring for a drug-eluting balloon) : main CRA for France and support for Germany
– Fastest activating and fastest recruiting French sites
– Site training, SIVs

• Monitoring & site management
– Routine monitoring, remote visits, data cleaning, CAPAs
– High-volume source verification on imaging-heavy CV studies
– Ensured compliance with MDR, ISO 14155, GCP

• Post-market clinical follow-up (PMCF)
– Follow-up visits for a Drug Eluted Stent post-approval trial
– Management of cardiovascular endpoints, device performance, and safety reporting

• User-feedback & eCRF development
– Worked with Clinical Project Leader and Data Manager on User Acceptability testing for a eCRF/EDC for a novel catheter system study
– Provided feedback to improve CRFs, workflows, and electronic tools

• Additional project exposure
– Supported early steps of a renal denervation study (pre-activation)

– Multi-country coordination with local CRAs & KOLs

Domains: coronary and peripheral interventions, drug-eluting devices, renal denervation, PMCF, ISO 14155, GCP, monitoring, data quality. #
Monitoring & Site Management (CRA/CRC) Formation Data Quality

Consulter toutes les expériences de Tom

Soyez le premier à recommander Tom

Contribuez à la réussite de ce freelance en partageant votre expérience de collaboration avec lui.

Agatha Frydrych

Backend Java Software Engineer

4.7

(3)

Baptiste Duhen

Fullstack developer

4.6

(4)

Amed Hamou

Senior Lead Developer

(2)

Audrey Champion

Web developer

4.3

(3)

S’inscrire pour les voir

Interpretation and Application of ICH E6(R2) Introduction to Translational Science WiDaF Plus - Wirtschaftsdeutsch - Expression - C1 (GER) Research Ethics Evaluation
Interpretation and Application of ICH E6(R2) Introduction to Translational Science WiDaF Plus - Wirtschaftsdeutsch - Expression - C1 (GER) Research Ethics Evaluation
Doctor of Philosophy (PhD) in Biology
University of Konstanz
2021
Doctor of Philosophy

Consultez la formation qu'a suivie Tom

Autre

Tom Lachaise

Clinical Research

À propos de Tom

Expériences

Domains: coronary and peripheral interventions, drug-eluting devices, renal denervation, PMCF, ISO 14155, GCP, monitoring, data quality. #

Recommandations

Ces profils de freelance correspondent également à vos critères

Formations

Compétences

Catégories