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!