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.

Languages

English
Native or bilingual
German
Conversational
French
Native or bilingual

Workplace preferences

Can work on-site

Clermont-Ferrand (up to 50km), Paris (up to 50km), Lyon (up to 50km)

MedKlar
Clinical Research & Evidence Generation Consultant (PhD)
PHARMACEUTICALS INDUSTRY
November 2022 - Today (3 years and 7 months)
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
RESEARCH
December 2023 - November 2025 (1 year and 11 months)
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
RESEARCH
November 2021 - October 2022 (11 months)
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

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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

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Other

Tom Lachaise

Clinical Research

About Tom

Experience

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

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