Louise GOEDHART
Freelance Consulting Services in Clinical Research
Villeneuve-le-Roi
Profil professionnel
With 20 years of experience in multiple areas of the pharmaceutical industry, solutions-oriented and a good communicator, I am looking for new opportunities to apply my knowledge and put my skills to your benefit.
I know how to manage a team and achieve set objectives. Rigorous, organized and with excellent communication skills, I am capable of supporting teams and improving the efficiency of operations.
Thanks to a true team spirit and excellent listening and communication skills, I know how to integrate without difficulty into new work contexts.
Vue d'ensemble
19
19
years of professional experience
9
9
years of post-secondary education
1
1
Certification
Expérience professionnelle
Consulting Services in Clinical Research
LG Consulting
11.2024 - Actuel
- Close collaboration with management teams to define objectives and action plans.
- Implementation of transformational projects aimed at improving operational efficiency.
- Project Management of Full Service Clinical Trials (Feasibility, Start-Up, Regulatory, Statistics, Data Management, Pharmacovigilance, Medical Writing)
- Regulatory submissions in Europe and USA
- Negotiation with suppliers to obtain advantageous conditions and reduce costs.
- Identification of opportunities for improvement and proposal of innovative solutions
Senior Global Clinical Project Lead
Aixial Group
Sèvres, France
01.2021 - 10.2024
- First point of contact for client - contractual, organisational, relationship
- Budget management and control
- Internal and external reporting
- Organisation of monthly meetings with Sponsor and project team
- Oversight of cross-functional study teams
- Identify and manage potential resourcing conflicts
- Ensure quality of work through strong communication skills and effective working relationships
- Risk management
- TMF review and quality control
- Vendor identification and management
- Handle multiple responsibilities/projects simultaneously
- Participation in Business Development activities
- Participation in key company initiatives
Medical Governance Manager
Aixial Group for GSK
Wavre, Belgium
04.2020 - 12.2020
- Responsible for the management of Medical Governance projects in Bioethics, Regulatory Intelligence, Policies & Written Standards, Scientific Engagement and Promotional Practices
Clinical Supply Set-Up Manager (CSSM)
Aixial Group for UCB
Braine l'Alleud, Belgium
03.2019 - 03.2020
- As a CSSM, I was accountable for the project management of study supply set-up and introduction of new capabilities within the Clinical Trial Supplies (CTS) department. I coordinated clinical supply activities for all applicable clinical trials during their set-up phase, aiming to achieve optimal quality, time and budget, and implement the strategy defined in collaboration with our stakeholders.
- Scope: All clinical trials (phase I to IV) + Compassionate Use Programs + Investigator Initiated Trials/Studies with CTS involvement
Medical Strategy and Operations
Aixial Group for GSK
Wavre, Belgium
05.2017 - 01.2019
- The GSK Vaccines Medical department was a group of 600 people, spread in 69 locations
- While driving strategy & performance systems, alignment and consistency needs to be ensured across the company
- As an expert consultant/project manager within the GSK medical department, I was accountable for supporting the delivery of Strategic and Operational activities within the Vaccines Medical Organisation and facilitating consistency
- I ensured alignment between the Vaccines and Pharma Medical Organisations in terms of strategy, communication and initiatives
Clinical Trial Manager
ClinSearch
Malakoff, France
04.2016 - 02.2017
- Small CRO specialized in epidemiological studies and trials involving medical devices, 50 employees
- Observational, prospective, multi-center, single-arm and open label study for subjects with cerebral arteriovenous malformations; Project Management Europe and Russia
- 5-year follow-up COHORT study of patients who initiated treatment for advanced melanoma through the French temporary authorization for use (ATU); Study set-up and Management
- Open-label prospective trial to explore the tolerability, safety and efficacy of a flexibly dosed ER treatment in subjects with Schizophrenia; long-term follow-up and project management of the trial for those patients sPll receiving the treatment in France
- Management and outcomes of patients treated for colorectal cancer: a retrospective review of six cases from the French ATU; Project set-up and management
Senior Clinical Research Associate/Lead CRA
QUINTILES
Levallois-Perret, France
01.2010 - 03.2016
- Full service CRO, Market Leader, Specialized in all phases of drug development, 30,000 employees worldwide; 800 in France
- In addition to international clinical monitoring activities, as a Lead CRA I was responsible for the transversal management of a team of CRA's, co-monitoring visits, review of Site Visit Reports, back-up of the Project Manager, supervising filing activities and the Trial Master File, quality control
- I also provided trainings in ICH-GCP to clinical operations staff
Medical Respresentative
Servier Laboratories
Northern Holland, Netherlands
01.2007 - 07.2009
- French Pharmaceuticals company mostly specialized in cardiology, 25,000 employees worldwide; 50 in The Netherlands
- Commercial development of several drugs in osteoporosis and cardiology
- Organization of medical events and product presentations to healthcare professionals; General Practitioners, pharmacists and regional hospitals
Project Assistant
Talent & Pro
Amersfoort
09.2005 - 09.2006
Formation
Master of Business Administration (MBA) - Management, Leadership and Entrepreneurship
NEOMA Business School
Paris 10.2015 - 09.2017
Licence professionnelle - Clinical Research
Institut Léonard de Vinci
Paris 10.2009 - 05.2010
Master of Arts - French Language & Literature
University of Amsterdam
Amsterdam 09.2000 - 07.2004
Bachelor in Science - Economic Sciences
University of Amsterdam
Amsterdam 09.1999 - 09.2001
Account Management 1 - Public Relations
Hogeschool Schoevers
Amsterdam 09.1998 - 09.1999
Compétences
Project Management and Leadership
Complex Project Management
Strategy, Delivery, and Operations
Strong communication skills
Analytical and Problem solving skills
Team motivation
Risk Management
Regulatory submissions IMP & MD
Vendor Management
Employee performance
Development and delivery of trainings
Management of change
Certificats
- The Master Channel - Masterclass Data Analytics for Business -March 2019
- AXELOS PRINCE2 Certification in Project Management - November 2018
- Barnett Educational Services - ICH-GCP Certification - passing score 95% - August 2014
- Dale Carnegie - Communication and customer excellence - 2013
Competencies
Therapeutic Areas
Cardiology, Endocrinology, CNS/Multiple Sclerosis, Ophthalmology, Oncology, Pediatrics, Dermatology, Osteoporosis
International experience
France, Belgium, Netherlands, Denmark, Germany, Spain, Switzerland, United Kingdom, Ireland
Clinical Trial Phases
Phase I, II, III, IV (Post-Marketing)/Medical Device
Languages
French
Bilingue
Dutch
Langue maternelle
English
Bilingue
Informations complémentaires
- "Cuisine du monde"
- Art and Aesthetics
- Seventh art
Frise chronologique
Consulting Services in Clinical Research
LG Consulting
11.2024 - Actuel
Senior Global Clinical Project Lead
Aixial Group
01.2021 - 10.2024
Medical Governance Manager
Aixial Group for GSK
04.2020 - 12.2020
Clinical Supply Set-Up Manager (CSSM)
Aixial Group for UCB
03.2019 - 03.2020
Medical Strategy and Operations
Aixial Group for GSK
05.2017 - 01.2019
Clinical Trial Manager
ClinSearch
04.2016 - 02.2017
Master of Business Administration (MBA) - Management, Leadership and Entrepreneurship
NEOMA Business School
10.2015 - 09.2017
Senior Clinical Research Associate/Lead CRA
QUINTILES
01.2010 - 03.2016
Licence professionnelle - Clinical Research
Institut Léonard de Vinci
10.2009 - 05.2010
Medical Respresentative
Servier Laboratories
01.2007 - 07.2009
Project Assistant
Talent & Pro
09.2005 - 09.2006
Master of Arts - French Language & Literature
University of Amsterdam
09.2000 - 07.2004
Bachelor in Science - Economic Sciences
University of Amsterdam
09.1999 - 09.2001
Account Management 1 - Public Relations
Hogeschool Schoevers
09.1998 - 09.1999
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