Associate Director – Study Start Up

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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 and deliver the study start-up phase for assigned projects on time, within scope, budget, and quality standards • Develop and maintain study start-up plans and track progress across assigned protocols • Provide proactive guidance to staff on site selection, submission strategy, amendment strategy, and customer management • Support staff in resolving significant study or site issues and escalate risks appropriately • Manage assigned budgets, maintain profitability, and ensure timely invoicing aligned with scope of work • Provide oversight to local vendors/contractors as applicable • Participate in business development activities, including proposals, budget development, and strategic input on country and site selection • Line manage staff in an international environment, including training, coaching, mentoring, and identifying process/training gaps • Lead process improvement initiatives and act as a key relationship manager for assigned customers • Collaborate closely with global functions such as Project Management, Data Management, Statistics, Medical Writing, Regulatory, and Safety

🎯 Requirements

• Bachelor’s degree, preferably in life sciences or nursing, or equivalent • Minimum 8 years of industry experience in clinical research, including at least 5 years in global clinical trials • Thorough knowledge of the clinical drug development process and study start-up phases • Strong understanding of GCP/ICH guidelines and applicable regulatory requirements • Excellent organizational, communication, customer service, and problem-solving skills • Proven ability to deliver results to quality, time, and financial metrics • Strong judgment and decision-making abilities • Ability to build and maintain effective working relationships with colleagues, managers, and customers • Fluent English • Ability and willingness to travel

🏖️ Benefits

• Competitive compensation package • Comprehensive benefits • Opportunity for personal and professional growth in a rewarding environment