Clinical Research Manager

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TFS HealthScience - Contract Research Organization

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2007

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

TFS HealthScience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies to advance clinical development. They offer a wide range of solutions including phase I-III clinical development, real-world evidence (Phase IV) studies, and strategic resourcing solutions. TFS HealthScience specializes in multiple therapeutic areas such as dermatology, internal medicine, neuroscience, oncology and hematology, ophthalmology, pediatrics, rare diseases, and orphan drugs. They aim to bring treatments to patients faster by combining their full-service capabilities and global reach with the flexibility and personalized approach of a mid-size CRO.

📋 Description

• Oversee day‑to‑day clinical operations to ensure delivery according to protocol, SOPs, ICH/GCP, and regulatory requirements • Serve as the primary operational contact for Sponsors, providing updates, managing expectations, and ensuring high‑quality study execution • Lead and support CRAs, including training, supervision, performance oversight, co‑monitoring, and review/approval of monitoring visit reports • Ensure site and country performance through proactive review of monitoring activities, protocol deviations, data listings, recruitment progress, and issue escalation • Maintain oversight of study documentation, including TMF quality, CTMS accuracy, monitoring plans, training plans, and study‑specific materials • Collaborate with the Project Manager on study planning, investigator payments, resource allocation, study communications, and revenue forecasting • Contribute to study meetings, Investigator Meetings, feasibility assessments, and, when required, local project management, CRA support, and bid defense activities

🎯 Requirements

• Minimum 5 years of clinical monitoring experience in a CRO, pharmaceutical, or biotechnology environment • At least 1 year of experience as a Clinical Research Manager (CRM) • 1+ years of experience in Ophthalmology (OPH), ideally within retina indications such as DME, AMD, GA, RVO, or inherited retinal diseases (IRDs) • Fluency in English, Spanish and Portuguese is required • Strong understanding of ICH/GCP, regulatory requirements, and clinical operations processes • Demonstrated ability to lead CRAs, manage study deliverables, and collaborate effectively with cross-functional teams

🏖️ Benefits

• Competitive compensation package • Comprehensive benefits • Personal and professional growth opportunities