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Lina M

Lina M

Project Manager/Oversight Manager

Pharmaceutique / Biotechnologie

Paris, Paris

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Services proposés

Seasoned professional with over 20 years of experience in Clinical Research, both on the field and in Project Management across multiple therapeutic areas.
Demonstrated ability to conduct clinical operations activities most effectively and efficiently, ensuring compliance, quality, and performance at every stage of the trial.

Recognized for strong analytical and negotiation skills, combined with a great sense of communication, diplomacy, and collaboration.
I’m passionate about building strong partnerships between sponsors, CROs, and sites to achieve successful study outcomes.

My mindset:
Focus on Customer. Innovate and Change. Work with Others. Achieve Results.

Clinical operations
Clinical research
Project management
Oversight management
Site management
Tarif approximatif: 100 € par heure

Expérience

EXPERIENCE

Freelance-Oversight Manager on Alzheimer disease study 

Aug-Oct 2025

 

Syneos Health – Project Manager

2014-2024

Responsible for project progress, reporting to the international study team 
Coordinate and maintain effective communication (oral, written) and serve as a sponsor contact for the investigators
Manage activities at sites and monitors study progress by providing guidance as required and by close collaboration with other key stakeholders (e.g. Medical Monitor, Protocol Manager, Clinical Trial Associates, Contract Administrators, Clinical Data Quality Managers and Site Monitors)
Identify potential issues at the site or protocol level and suggest resolutions. Answer and resolve routine or site related questions independently 
Ethic Committee submission
Budget handling and negotiation 

DOCS International – Local Trial Manager

2010-2013

Team management and training (CRAs to Sr CRAs)
Team meetings Leader 
Budgets management and negotiations 
Adaptation of the contract with the investigators sites and hospital direction 
Organizing and animation of investigators’ meetings and kick off meetings
Responsible for project progress, reporting to the international study team 
Ethic Committee  and Health Authorities submissions oversight
Initiation,  Monitoring and Close-Out visits
Development and translation of site specifics tools (patient diary, study summary, study triptych, recruitment tools)
Develops patient enrolment strategies with the project team study sites  
Sites’ management KENDLE International – CRA II

2007-2010

Monitoring activities (Sites selection, initiation, monitoring and close-out)

Ethic Committee and Health Authorities submissions support FOVEA – CRA

2005-2006  Monitoring activities (Sites selection, initiation, monitoring and close-out)

Éducation

Clinact CRA certification

2005

Sévres-France

Masters – Quality Assurance

2004

UNIVERSITY BLAISE-PASCAL, CLERMONT-FERRAND - France 

 

Masters - Biochemistry

2003

UNIVERSITY SOPHIA -ANTIPOLIS, NICE - France 

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