Centralized Clinical Team Lead Ii

2 semanas atrás

São Paulo SP, Brasil Fortrea Tempo inteiro

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. Conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

We are seeking an experienced professional to lead central monitoring activities, ensure the quality of clinical trial processes, and proactively manage risk. As a Centralized Clinical Team Lead, you will play a vital role in ensuring compliance, mentoring teams, and delivering data-driven insights that enhance trial outcomes.

Key Responsibilities:

- Review trip reports, identify risks, and communicate trends to study teams.
- Execute and oversee central monitoring activities, including study analytics, risk assessment, and mitigation planning.
- Lead initiatives in trip report optimization and provide mentorship to CRAs and other team members.
- Develop strategies for risk-based monitoring, including SDV and risk trigger management.
- Collaborate on regulatory readiness and ensure effective cross-functional team coordination.

Qualifications:

- Degree in Life Sciences or related field; advanced qualifications preferred.
- 8+ years in clinical research, with 2+ years in centralized monitoring or trip report review.
- Expertise in ICH-GCP guidelines and regulatory compliance.
- Strong organizational, analytical, and interpersonal skills.

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.

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