Clinical Trial Lead

Il y a 4 mois

RueilMalmaison, France Fortrea Temps plein

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Dedicated to one of our Sponsor, you will be responsible for study oversight and delivery management (time, budget, quality) at country level from start-up to closure and will serve as the main point of contact at country level for internal and external stakeholders.

**Responsibilities**:

- Coordinates proposal and validation of country study targets and develop patient recruitment strategy & risk mitigation.
- Leads problem solving and resolution
- Assessment and set up of vendors during study start up period (locally)
- Investigator Meeting participation and preparation
- Ensures CTMS and eTMF accuracy
- Validation of study related materials (i.e. protocol, ICF, patient material) and preparation of country specific documents (e.g. amendments)
- Prepares materials for Site Initiation Visits
- Reviews Site Monitoring visit reports,
- Coordination of database locks and query follow up and ensures timelines are met.
- Ensure inspection readiness of assigned trials within country
- Coordinates, develops and writes CAPA and ensures implementation for audit findings.
- Reviewing and approving payments
- Management of Site relationships (includes CRO related issues)
- May support preparing submissions to and obtaining approval from local Health Authorities, Ethics Committees and other relevant instances

Qualifications:

- Excellent understanding of GCP, ICH Guidelines and Country regulatory environment
- In depth knowledge of clinical research processes, regulations and methodology
- High organizational and planning skills as well as independent decision-making ability
- Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives
- Critical thinking and risk analysis
- Strong communication skills with a strong customer focus, able to manage both internal and external clients at all organizational levels

Did you know?

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit


Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

For more information about how we collect and store your personal data, please see our

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