Antoine Mequignon
Clinical Project Lead, EU
38 years old
Driving License
Professional Status
Employed
Open to opportunities
Clinical Project Lead, EU
Rhythm Pharmaceuticals
Since September 2018
Full-time
Paris
- Rhythm is a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic disorders of obesity.
- Management and support of clinical studies and registries across Europe
Clinical Study Manager (Contractor at Guerbet)
Hays Pharma
January 2018
to August 2018
Full-time
Paris
France
- Management of an international paediatric phase II trial on contrast media for MRI
Clinical Trial Operations Manager (Contractor at Sanofi)
Hays Pharma
November 2012
to December 2017
Full-time
Paris
France
- Management of an international Phase IV study in Diabetes - (March 2016, Present) - 7 Countries – 230 Patients
- Management of an international NPP in Oncology - (June 2015, Present) - 38 Countries – 1100 Patients
- Management of an international Phase IV study in multiple sclerosis (January 2014, Present) - 14 Countries – 1000 Patients
- Management of an international named patient program in oncology (November 2012, Present) - 25 Countries – 750 Patients
- Management of a product registry in diabetes (November 2012, January 2014) - 10 Countries – 3100 Patients
- RFPs, Budget/AED, feasibility, vendors’ selection
- Coordination of contracts research organization, interactions with vendors, set-up and follow-up activities (Data Management and Statistics, Central Lab, IRT)
- Coordination and support of field-monitoring activities through regular meetings: teleconferences, CSU/CTT, preparation and review study documents
- Monitoring team training
- Data Cleaning activities
- Database lock
- Monthly report
Clinical Trial Operations Manager
Sanofi
October 2011
to October 2012
Apprenticeship
Chilly Mazarin
France
- Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in healthcare, with 6 growth platforms: emerging markets, vaccines, consumer healthcare, diabetes treatments, innovative products and animal health. Through the acquisition of Genzyme, Sanofi has strongly reinforced its footprint in rare diseases.
- Operational planning and activities for the implementation and conduct of an international phase III study on multiple sclerosis
- Data management
- Coordination of a clinical research organization, interactions with vendors and follow-up activities (Central Lab)
- Coordination and support field-monitoring activities through regular meetings: teleconferences, CSU/CTT, preparation and review of monitoring plan, communication plan.
- Data Review and Surveillance, Medical review
- Validation Listing Specification
- Internal Training: Data Management, Statistics Basics, Data Review, Cleaning & Surveillance
Clinical Research Associate
CIC-IT
March 2011
to August 2011
Internship
Lille
France
- Lille Clinical Investigation Centre for Innovative Technology (CIC-IT) was created by the Ministry of Health (DHOS) and the INSERM in 2008. It is dedicated to eHealth and entitled "Bio-capteurs et e-Santé : innovation et usages" (Biosensors and eHealth: Innovation and Uses). Thanks to its integration into Lille Hospital Campus, it has easy access to the Hospital and University platforms.
The CIC-IT is strategically situated on Eurasanté business park. It rests on a strong partnership with Lille multi-topic CIC and the public health hospital and university research teams.
Lille CIC-IT gathers pluridisciplinary skills in computing, signal processing, ergonomics, human factors and Man-Machine Interfaces. - Clinical trials management of national phase II/III studies on a medical device analyzing the autonomic nervous system activity through ECG in neonatology intensive care unit (Newborn Infant Parasympathetic Evaluation)
- Recording of patients’ data on site and CRF completion
- Data treatment
- Statistical analysis
- Interactions with healthcare professionals and patients
Clinical Research Associate
Internal Medicine Department - Huriez Hospital
May 2010
to June 2010
Internship
Lille
France
- Industrial and institutional protocols follow up at the CRMR (Reference Center for Rare Diseases)
Clinical Research Associate
Clinical Investigation Centre for Innovative Technology
February 2010
to April 2010
Internship
Lille
France
- Lille Clinical Investigation Centre for Innovative Technology (CIC-IT) was created by the Ministry of Health (DHOS) and the INSERM in 2008. It is dedicated to eHealth and entitled "Bio-capteurs et e-Santé : innovation et usages" (Biosensors and eHealth: Innovation and Uses). Thanks to its integration into Lille Hospital Campus, it has easy access to the Hospital and University platforms.
The CIC-IT is strategically situated on Eurasanté business park. It rests on a strong partnership with Lille multi-topic CIC and the public health hospital and university research teams.
Lille CIC-IT gathers pluridisciplinary skills in computing, signal processing, ergonomics, human factors and Man-Machine Interfaces. - Validation of a device analyzing the autonomic nervous system activity for pain measurement during general anaesthesia.
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French (mother tongue)
Expert
-
English
Advanced
-
Microsoft Office
Advanced
-
MS Project
Good
-
SPSS Statistics
Intermediate
-
SQL Developer
Intermediate
-
InForm
Intermediate
-
Oracle Clinical
Intermediate
-
Adobe Photoshop
Good
-
Adobe Dreamweaver
Good
-
Trial Management
Advanced
-
CRF Design
Advanced
-
Data management
Advanced
-
Good knowledge of ICH GCP and regulatory requirements, dynamism, diligence, adaptation ability at short notice, analysis and synthesis skills.
Advanced
Master's Degree in Health Engineering & Clinical Research
ILIS - Faculty of Health engineering and management - Lille, FRANCE
September 2010
to October 2012
Risk management
Medical writing
Pharmaceutical marketing
Statistical technics in clinical research
Food and cosmetics in clinical research
Bachelor's Degree in Health and Biomedical Technology
ILIS - Faculty of Health engineering and management - Lille, FRANCE
September 2008
to June 2010
Physiology
Pharmacology
Biology
Marketing
Communication
Accounting
Clinical Research
Statistics
