Project Design Manager

Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
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.

Knowledge, Skills and Abilities:
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!