Study Design Lead

Role Overview

• Accurately interpret and translate sponsor protocol requirements into the protocol specific database to generate a Statement of Work for the CLS project.
• Leverage technical, therapeutic area, client, and company specific process knowledge to provide a comprehensive and complete database design.
• Interact with external clients regularly through all duties and responsibilities.
• Liaise with internal departments to understand full company capabilities and assess feasibility of requests to meet client needs related to study design.
• Act as a consultant to advise on study design choices and work with the Global Study Manager (GSM) to highlight risks and budget impacts associated with study design.
• Expand consultancy capability at study program levels.
• Display strong interpersonal and communication skills that will build strong internal and external relationships to ensure high quality study design.
• Coordinate internal processes and communications related to study design (including but not limited to internal feasibility requests, material transfer agreements and supply forecasting) and ensure the eventual follow up is integrated into the database and global monitoring plan.
• Perform quality self-review.
• Ensure that all customer requirements with relation to study design are documented and acted upon.
• Act efficiently in an environment with dynamic timelines and priorities.
• Display appropriate self-organization and ability to manage conflicting priorities.
• Participate in functional meetings (e.g. Continuous Learning Forums (CLFs)) and provide input, keeping processes up to date.
• Comply with our internal Central Lab Global Project Management strategy.
• Manage a portfolio of global and local studies with varying complexities.
• Support a culture of continuous improvement, quality, and productivity.

Requirements

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

Benefits

• Health insurance
• 401(k) matching
• Paid time off
• Flexible work arrangements