Project Design Manager

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 Youll Do:

Central Laboratory Specifications (CLS) Development:

• Independently draft and modify CLS for lowhigh 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 lowhigh 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:

• Bachelors 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 clients 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. Youll 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 tomorrows breakthrough!