Study Start Up Lead

🔥 4 minutes ago

🇵🇱 Poland – Remote

⏰ Full Time

🟠 Senior

👻 Ghost score 10%

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TFS HealthScience - Contract Research Organization

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2007

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

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

• Lead and oversee study start-up activities across assigned projects from award to site activation • Develop and maintain start-up plans, timelines, and project milestones • Partner with Project Managers to identify risks and implement mitigation strategies • Coordinate Ethics Committee (EC/IRB) submissions and collaborate with Regulatory teams on Health Authority requirements • Support site feasibility, site activation, and greenlight processes • Coordinate clinical trial agreement negotiations alongside Legal and operational teams • Ensure study documentation is complete, accurate, and submitted to the Trial Master File • Monitor start-up metrics and provide regular progress updates to project stakeholders • Support continuous improvement initiatives, SOP development, and operational best practices • Contribute to bid defenses, proposals, and business development activities when required

🎯 Requirements

• Bachelor's degree in Life Sciences, Nursing, or a related field • Minimum 4 years of clinical research experience with a strong focus on study start-up activities • Good understanding of ICH-GCP guidelines and regulatory requirements • Experience coordinating multiple projects in a fast-paced environment • Strong organizational, planning, and problem-solving skills • Excellent written and verbal communication skills in English • Experience in submissions in the US and Australia is good to have

🏖️ Benefits

• Competitive compensation package • Comprehensive benefits • Opportunity for personal and professional growth • Collaborative and innovative work environment