Project Design Manager, Central Labs

The Project Design Manager independently reviews clinical trial protocols and interprets Central Lab responsibilities based on protocol definitions and budgeted services. In this position, you will advise Project Managers on procedural and budgetary items and the necessity for change due to database configuration requirements. This role supports the Project Manager in the review of draft laboratory specifications document for consistency with protocol and budgeted requirements; provides feedback to the Project Manager regarding budget and/or protocol discrepancies, system design requirements, and/or concerns.

What You Will Do

Key responsibilities include ensuring consistency of database design across sponsors and/or programs, configuring Collection Flow Chart (CFC) and Kit Specifications based on protocol testing requirements, and determining appropriate testing to sample allocation based on testing schedule, processing instructions, sample disposition, and third-party lab requirements.

Why It Might Be a Fit

The ability to work on a team, as well as independently, while maintaining clear communication and attention to detail is key to this role. You will work cross-departmentally to ensure study database design meets client needs, as well as internal requirements.

Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years)
• Familiarity with Clinical Trial Database within Central Laboratory environment
• Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines
• Effective project management and organizational skills
• Good computer skills
• General knowledge of clinical trial processes and programs
• Strong attention to detail and problem-solving skills
• Good written and verbal communication skills
• Ability to effectively conduct oral presentations
• Demonstrated experience in identification and resolution of technical problems in a professional environment
• Ability to maintain a high degree of confidentiality with clinical teams
• Ability to attain, maintain and apply a working knowledge of applicable procedural documents
• Demonstrated positive attitude, enthusiasm toward work, and the ability to work well with others

Benefits

• Health and wellbeing of employees
• Healthy and balanced environment
• Comprehensive background check
• Drug screening
• Accessibility service for job seekers requiring accommodations in the job application process