Study Design Lead

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

📋 Description

• Interpret and translate sponsor protocol requirements into databases tailored for specific protocols to create Statements of Work for Central Lab Services projects.

• Deliver thorough database designs utilizing technical knowledge, therapeutic expertise, client-specific requirements, and company procedures.

• Engage consistently with external clients.

• Collaborate with internal departments to evaluate feasibility and fulfill client needs regarding study design.

• Provide guidance on study design options and collaborate with the Global Study Manager to identify potential risks and budget implications.

• Organize internal processes and communications related to study design, including feasibility requests, material transfer agreements, and supply forecasting.

• Incorporate follow-up tasks into databases and global monitoring strategies; conduct quality self-reviews.

• Document and address customer requirements pertaining to study design.

• Manage shifting timelines, competing priorities, and a range of global and local studies with varying levels of complexity.

• Participate in functional meetings and assist in keeping processes current.

• Adhere to the Central Lab Global Project Management strategy.

• Contribute to ongoing improvements in quality and productivity.

⛳️ Requirements

• Bachelor’s degree in a life science field.

• Minimum of 6 years of experience in the clinical research industry or a laboratory setting.

• Preferred: Master’s degree in a life science.

• Preferred: At least 6 years of experience in Central Lab Project Management.

• Experience in direct interactions with internal or external customers.

• Strong skills in building and managing relationships.

• Familiarity with clinical or preclinical research protocols.

• Solid planning, organizational, and problem-solving abilities.

• Outstanding verbal and written communication skills.

• Proficient in computer applications, including Windows, Excel, and Word.

🏝️ Benefits

• Commitment to Equal Opportunity Employment.

• Reasonable accommodations available for individuals with disabilities during the online application process.

• Opportunities for global career advancement.

• Chance to engage in meaningful work that positively impacts people's health.