Lina M

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.

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)

Clinact CRA certification

2005

Sévres-France

Masters – Quality Assurance

2004

UNIVERSITY BLAISE-PASCAL, CLERMONT-FERRAND - France

Masters - Biochemistry

2003

UNIVERSITY SOPHIA -ANTIPOLIS, NICE - France