Project Design Manager I

Employment Type: Full-time Work Schedule: Standard (Mon-Fri) Location: Remote (US) Environmental Conditions: Office

Position Overview

The Project Design Manager I plays a crucial role within the PPD® Laboratory Services team, directly impacting patient health through scientific expertise. As a key member of the Clinical Research Group / Global Central Labs, this position supports the Project Manager by independently reviewing clinical trial protocols and interpreting Central Lab responsibilities based on protocol definitions and budgeted services. The role involves advising Project Managers on procedural and budgetary matters, as well as system design requirements stemming from database configuration.

Responsibilities

• Ensures consistency of database design across sponsors and/or programs.
• Configures Collection Flow Chart (CFC) based on protocol testing requirements, assay volumes, testing location, sample stability, and frequency of testing.
• Determines appropriate testing to sample allocation based on testing schedule, processing instructions, sample disposition, and third-party lab requirements.
• Configures Kit Specifications based on protocol testing requirements, assay volumes, testing schedule, testing location, sample stability, testing frequency, study population, assay platform, total allowable blood volume, sponsor/program requirements, and ancillary supply requirements.
• Configures sample labels based on client needs and collection requirements.
• Attends internal and external meetings and teleconferences.
• Provides Project Manager support during laboratory specifications development discussions with clients.
• Works cross-departmentally to ensure study database design meets client and internal requirements.
• Seeks input and guidance from project design leads and managers when necessary.
• Builds study databases and creates study deliverables within established timelines under general supervision.
• Supports the Project Management group with the development and implementation of study database design modifications.
• Performs database modifications based on client requirements, updating CFC, Kit Specifications, and sample labels as appropriate.
• Monitors assignments and adjusts priorities and work schedules to meet deadlines and ensure high-quality deliverables.
• Completes additional tasks as needed to support project, client, and departmental objectives.
• Understands and follows department working practice documents and SOPs, contributing to their development as needed.
• Understands and follows appropriate corporate SOPs.

Requirements

• Education: Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
• Experience: Previous experience providing the knowledge, skills, and abilities to perform the job (comparable to 2+ years) or an equivalent combination of education, training, and experience.
• Ability to work effectively both independently and as part of a team.
• Clear communication skills.
• Strong attention to detail.

Company Information

Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders, and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.