Project Design Manager, Central Labs

About the role

This is a fully remote role supporting our Global Central Laboratories. We welcome applicants from all locations within the US. Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening.

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.

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, as well as determining ancillary supply requirements based on matrices, time points, study population, and collection device 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 client.
• Works cross-departmentally to ensure study database design meets client needs, as well as internal requirements.
• Seeks input and guidance from project design leads and managers when necessary.
• Under general supervision and guidance from project design leads and managers, builds study database and creates study deliverables within the timelines established by the team and indicated by the contract.
• Supports Project Management group with the development and implementation of study database design modifications.
• Performs database modifications based on client requirements; updates CFC, Kit Specifications, and sample labels, as appropriate, based on database modifications.
• Monitors assignments and adjusts priorities and work schedule to meet deadlines and provide high quality deliverables.
• Completes additional tasks as needed to support project, client, and departmental objectives.
• Understands and follows department's working practice documents and SOPs, and contributes to their development as needed, as well as understands and follows appropriate corporate SOPs.

Qualifications

Education and Experience

• 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). In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Skills and Abilities

• Familiarity with Clinical Trial Database within Central Laboratory environment strongly preferred.
• 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.

Environmental Conditions

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• May require travel. (Recruiter will provide more details.)

Schedule

Standard (Mon-Fri)

Why Join Us

When you join us, you become part of a global organization committed to enabling customers to make the world healthier, cleaner, and safer. You’ll collaborate with industry-leading experts, contribute to groundbreaking clinical research, and grow within an environment that values innovation, accountability, and continuous development.