Senior Clinical Research Manager
hace 2 días
Company Overview: Fortrea is a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience.
Estimated Salary: $85,000 - $120,000 per year
Job Description:
Clinical Trials Management:
- Accountable for execution and oversight of local operational clinical trial activities
- Has ownership, oversight, and impact on local regulatory and financial compliance at a country operations level
Key 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
- Management: POC for assigned protocols, pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments for assigned protocols
- Quality Oversight: Responsible for quality and compliance in assigned protocols in country, oversees CRAs and CTCs on assigned projects, performs quality control visits, reviews Monitoring Visits Reports and escalates performance issues and training needs
- External Customer Facing: Collaborates with functional outsourcing vendors, investigators, other external partners, oversees country and site validations, site selection and recruitment in assigned protocols
- 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
Requirements:
- 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
- Mandatory, in lieu of the above requirement, candidates with minimum of two or more years of relevant clinical research experience as local study manager in pharmaceutical or CRO industries or experience in a healthcare setting will be considered
- Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
- Fluent in local office language and in English, both written and verbal
About Fortrea: 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.
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