Clinical Research Manager

5 mesi fa

Milano, Italia Fortrea A tempo pieno

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.

The Clinical Research Manager is accountable for execution and oversight of local operational clinical trial activities and has ownership, oversight, and impact on local regulatory and financial compliance, at a country operations level at the client in compliance with ICH GCP and country regulations.

Summary of Responsibilities:

- PERFORMANCE: Accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally. 30%
- MANAGEMENT: POC for assigned protocols. Pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments for assigned protocols. Strong collaboration with local CO roles. Forecasts country resource needs. Serves local business needs (signs contracts, manages budgets as delegated). 20%
- QUALITY OVERSIGHT: Responsible for quality and compliance in assigned protocols in country.

Oversees CRAs and CTCs on assigned projects. Oversees training compliance. Performs quality control visits. Reviews Monitoring Visits Reports and escalates performance issues and training needs to functional vendor and internal management as needed. Oversees associate CRMs assigned to the Client and work on training needs in collaboration with functional vendor. 20%
- EXTERNAL CUSTOMER FACING: Responsible for collaboration with functional outsourcing vendors, investigators, other external partners. Oversees country and site validations, site selection and recruitment in assigned protocols. Responsible for clinical trial education to sites. Country POC for programmatically outsourced trials for assigned protocols. 20%
- INTERNAL COLLABORATION & STRATEGY: Collaborates internally with local PV, Regulatory, GMA/GHH to align on key decisions in countries. Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD and Regional Operations. 10%
- All other duties as needed or assigned.

Qualifications (Minimum Required):

- University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
- Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries.
- Thorough understanding of the drug development process.
- Fluent in local office language and in English, both written and verbal.

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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