Study Design Lead

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

📋 Description

• Interpret and translate sponsor protocol requirements into protocol-specific databases while generating Statements of Work for Central Lab Services projects.

• Deliver comprehensive database designs utilizing technical, therapeutic-area, client, and company process knowledge.

• Engage regularly with external clients to foster collaboration.

• Collaborate with internal departments to evaluate feasibility and fulfill client study-design requirements.

• Provide guidance on study-design options and work alongside the Global Study Manager to pinpoint risks and budget implications.

• Establish robust internal and external relationships to ensure high-quality study design outcomes.

• Oversee internal study-design processes and communications, including feasibility requests, material transfer agreements, and supply forecasting.

• Integrate follow-up actions into databases and global monitoring plans, and conduct quality self-reviews.

• Document and address customer study-design specifications effectively.

• Manage fluctuating timelines, competing priorities, and a diverse portfolio of global and local studies of varying complexity.

• Engage in functional meetings and contribute to the ongoing enhancement of processes.

• Adhere to the Central Lab Global Project Management strategy consistently.

• Promote continuous improvement, quality enhancement, and productivity.

⛳️ Requirements

• Bachelor’s degree in a life science field.

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

• Proven experience working directly with internal or external clients.

• Strong skills in relationship building and management.

• Familiarity with clinical or preclinical research protocols is essential.

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

• Superior verbal and written communication skills.

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

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

• Preferred: Over 6 years of experience in Central Lab Project management.

🏝️ Benefits

• Commitment to being an Equal Opportunity Employer.

• Consideration of qualified applicants without regard to protected characteristics.

• Accessibility assistance and reasonable accommodation for applicants with disabilities.