Study Design Lead

Overview

As Study Design Lead, you will translate sponsor protocols into database design and SOWs, guiding study design decisions and communicating with clients and internal teams. You’ll shape study programs, assess feasibility, and help manage risks and budgets, while driving consistency across global studies. This role sits in Central Laboratories Services and offers remote collaboration with cross-functional partners to deliver high-quality design and process improvements.

Responsibilities

• Translate sponsor protocols into protocol-specific database designs and generate SOWs for CLS projects
• Provide comprehensive database design leveraging technical, therapeutic, client, and company knowledge
• Interact with external clients regularly and liaise with internal departments to assess feasibility and capabilities
• Advise on study design choices and highlight risks and budget impacts with GSM
• Expand consultancy capability at study program levels
• Demonstrate strong interpersonal and communication skills to build internal and external relationships
• Coordinate internal processes related to study design (feasibility requests, material transfer agreements, supply forecasting) and ensure follow-up is integrated into the database and global monitoring plan
• Participate in functional meetings and contribute to keeping processes up to date
• Comply with Central Lab Global Project Management strategy and manage a portfolio of global/local studies
• Support a culture of continuous improvement, quality, and productivity
• Perform quality self-review and document customer requirements related to study design

Key requirements

• Bachelor’s degree in a life science
• 6 or more years of experience in clinical research or a lab environment
• Excellent verbal and written communication skills
• Strong planning, organizational, and problem-solving skills
• Experience working directly with internal or external customers
• Familiarity with clinical or preclinical research protocols
• Strong relationship-building and management skills
• Excellent skills using Windows, Excel, Word

• interpersonal skills
• communication
• relationship management
• protocol-specific database design
• SOW drafting
• study design techniques for database creation

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