Senior Clinical Research Manager for Hematology Trials
hace 2 semanas
Overview
">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.
">About the Role
">We are seeking an experienced Clinical Research Manager to join our team in a Senior position. The successful candidate will be responsible for overseeing local operational clinical trial activities and ensuring compliance with ICH GCP and country regulations.
">Main 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: Proactively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments for assigned protocols. Forecasts country resource needs. Serves local business needs (signs contracts, manages budgets as delegated).">
- Quality Oversight: Responsible for quality and compliance in assigned protocols in the country. Oversees CRAs and CTCs on assigned projects. Performs quality control visits.">
- External Customer Facing: Collaborates with functional outsourcing vendors, investigators, and 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
">To be considered for this role, you must have at least 2/3 years of experience in the field of Hematology AND Oncology trials. Additionally, you should possess excellent organizational and time management skills, working knowledge of ICH, FDA, local regulatory requirements, IRB/IEC, and other applicable regulations/guidelines.
">Benefits and Remuneration
">The salary for this position is approximately $110,000 per year, plus additional benefits such as health insurance, retirement plan, and paid time off.
">Contact Information
">For more information about this opportunity, please visit our website or contact our HR department.
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