Work Schedule

Environmental Conditions

Job Description

Join us as a Project Design Manager and use your skills to support the design and configuration of clinical trial laboratory databases.

What You’ll Do:

Central Laboratory Specifications (CLS) Development:

• Independently draft and modify CLS for low–high complexity studies to a high standard, frequently meeting or exceeding target review finding ranges

• Make informed design decisions within database and regulatory constraints

• Advise and influence study teams rather than deferring decisions externally

• Anticipate reviewer feedback and proactively address risks

• Independently meet with study teams during CLS development to ensure effective communication, clarify requirements, and support accurate translation of protocol, budget, and SMP requirements into the CLS

• Communicate proactively with project team members to support CLS development and provide timely updates to management regarding potential timeline, budget, or resourcing constraints

Database Build:

• Independently build and modify study databases of low–high complexity

• Deliver work very efficiently and to a high standard, frequently meeting or exceeding target review finding ranges

• Create and modify site deliverables with minimal rework

• Proactively support CLS updates and respond efficiently to review findings

• Communicate proactively with project team members and provide timely updates to management regarding potential timeline, budget, or resourcing constraints impacting database build activities

Review:

• Perform CLS and database reviews using established checklists

• Identify and document clear, actionable findings

• Collaborate with CLS and Builder teams to resolve issues

• Apply standards consistently and accurately

• Participate in discussions with study teams as required to clarify review findings, support effective communication, and ensure review expectations and outcomes are clearly understood

• Communicate proactively with project team members regarding review activities and escalate potential timeline, resourcing, or quality-related concerns to management as identified

Additional Responsibilities:

• Act as a Sponsor Subject Matter Expert (SME) where required, providing knowledgeable, accurate guidance on system design, functionality, and study-specific implementation considerations appropriate to role level

• Serve as a technical SME for specific database items or functionality, applying in-depth system knowledge to support study design, build, and quality activities

• Contribute to the development, review, and maintenance of Study Design training materials, sharing subject matter expertise and supporting the onboarding and development of team members

• Support other Study Design team functions as required, collaborating across teams to ensure quality, consistency, and timely delivery

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.

• Good oral and written communication skills

• Solid organizational skills and time management skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines

• Capable of maintaining a high degree of confidentiality with clinical data and client’s proprietary data

• Strong attention to detail and problem-solving skills

• Demonstrated positive attitude, enthusiasm toward work, and a good team player

• Solid understanding of relational database systems (RDBMS) and structures

• Solid understanding of the identification and resolution of technical problems in a professional environment

• Firm understanding of the data exchange between applications is preferred

• Good understanding of webservices and working with APIs is preferred

Why Join Us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience – and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthrough!