Study Design Lead

This is a fully remote position, open to applicants in Poland.

📋 Description

• Accurately interpret and translate sponsor protocol requirements into a protocol-specific database to create a Statement of Work for the CLS project.

• Utilize technical, therapeutic area, client, and company-specific process knowledge to ensure a comprehensive and complete database design.

• Regularly interact with external clients throughout all duties and responsibilities.

• Collaborate with internal departments to understand the full range of company capabilities and evaluate the feasibility of requests to fulfill client needs related to study design.

• Serve as a consultant to offer advice on study design options and work alongside the Global Study Manager (GSM) to identify risks and budget implications associated with study design.

• Enhance consultancy capabilities at the study program level.

• Exhibit strong interpersonal and communication skills that foster robust 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 subsequent follow-ups are integrated into the database and global monitoring plan.

• Conduct quality self-reviews.

• Ensure that all customer requirements regarding study design are documented and addressed.

• Act decisively in an environment characterized by dynamic timelines and shifting priorities.

• Demonstrate proper self-organization and the ability to manage conflicting priorities.

• Participate in functional meetings (e.g., Continuous Learning Forums (CLFs)) and contribute input, ensuring processes remain current.

• Adhere to our internal Central Lab Global Project Management strategy.

• Manage a portfolio of global and local studies with varying levels of complexity.

• Foster a culture of continuous improvement, quality, and productivity.

⛳️ Requirements

• Bachelor’s degree in a life science.

• 6 or more years of experience 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 abilities.

• Excellent verbal and written communication skills.

• Proficient in using computer applications (e.g., Windows, Excel, Word).

🏝️ Benefits

• Health insurance.

• Flexible working arrangements.

• Professional development opportunities.