Project Design Manager I - Central Lab

📍 Job Overview

Job Title: Project Design Manager I - Central Lab

Company: Thermo Fisher Scientific

Location: Remote (US-Wide)

Job Type: Full-time

Category: Operations Management / Clinical Laboratory Operations

Date Posted: June 11, 2026

Experience Level: 2-5 Years

Remote Status: Fully Remote

🚀 Role Summary

• Oversees the design and configuration of central laboratory services for clinical trials, ensuring alignment with protocol requirements and budgetary constraints.

• Manages the creation and refinement of critical study documentation, including Collection Flow Charts (CFCs) and Kit Specifications, to support accurate and efficient sample processing.

• Collaborates cross-functionally with Project Management, scientific teams, and clients to translate clinical trial protocols into robust laboratory operational designs.

• Ensures consistency and accuracy in database configurations across multiple sponsors and research programs, adhering to stringent regulatory and quality standards.

📝 Enhancement Note: This role is classified as a Project Design Manager, indicating a focus on the foundational operational planning and system setup for clinical trials within Thermo Fisher Scientific's Central Lab services. The "I" designation suggests an entry to mid-level management position, requiring foundational experience but offering opportunities for significant project ownership and impact. The emphasis on "Central Lab" and "Clinical Trial Protocol Review" firmly places this within the specialized domain of GxP-regulated laboratory operations, requiring meticulous attention to detail and process adherence.

📈 Primary Responsibilities

• Independently review and interpret clinical trial protocols to define Central Lab responsibilities, ensuring comprehensive understanding of testing requirements, sample volumes, and budgeted services.

• Advise Project Managers on procedural and budgetary implications stemming from protocol definitions and database configuration needs, proactively identifying potential discrepancies.

• Support Project Managers in reviewing draft laboratory specifications documents, providing critical feedback on consistency with protocol, budget, and system design requirements.

• Configure Collection Flow Charts (CFCs) by analyzing protocol testing needs, assay volumes, testing locations, sample stability, and testing frequency to optimize sample allocation and processing.

• Design and configure Kit Specifications, considering protocol requirements, assay volumes, testing schedules, sample stability, study population, assay platforms, and ancillary supply needs.

• Develop and configure accurate sample labels based on client specifications and collection requirements, ensuring clear and compliant sample identification.

• Attend internal and external meetings, including client teleconferences, to support Project Managers and contribute to laboratory specifications development discussions.

• Collaborate effectively with cross-departmental teams to ensure study database designs meet both client expectations and internal operational requirements.

• Build study databases and create study deliverables within established timelines, seeking guidance from project design leads and managers as needed.

• Support the Project Management group by implementing study database design modifications as required by client needs or evolving study parameters.

• Perform necessary database modifications, updating CFCs, Kit Specifications, and sample labels in response to client-driven changes.

• Monitor assigned tasks, proactively adjust priorities, and manage work schedules to meet deadlines while consistently delivering high-quality outputs.

• Adhere to and understand departmental working practice documents and Standard Operating Procedures (SOPs), contributing to their development and improvement.

• Complete additional tasks as assigned to support project, client, and departmental objectives, demonstrating flexibility and a commitment to team success.

📝 Enhancement Note: The responsibilities highlight a critical intersection of scientific understanding, project management, and system configuration. The role demands a strong ability to translate complex clinical trial protocols into actionable laboratory operational plans. The emphasis on "database design," "CFC configuration," and "Kit Specifications" points to the use of specialized laboratory information management systems (LIMS) or similar platforms, requiring a detailed understanding of how these systems support GxP workflows.

🎓 Skills & Qualifications

Education:

• Bachelor's degree or equivalent formal academic or vocational qualification in a relevant scientific or technical field. Experience:

• Approximately 2+ years of experience in a regulated clinical or laboratory services environment (e.g., Central Lab, Bioanalytical Lab).

• Proven ability to perform essential job functions through equivalent combinations of education, training, and experience. Required Skills:

• Clinical Trial Protocol Review: Ability to meticulously review and interpret complex clinical trial protocols to define laboratory service requirements.

• Database Configuration: Proficiency in configuring and managing study databases, ensuring accuracy and consistency for clinical trial data.

• Laboratory Specifications Development: Experience in developing and reviewing laboratory specifications, including Collection Flow Charts (CFCs) and Kit Specifications.

• Project Management Fundamentals: Effective organizational and project management skills to handle multiple assignments and meet challenging deadlines.

• Attention to Detail: Exceptional attention to detail to ensure accuracy in configuration, documentation, and data management within a regulated environment.

• Problem-Solving: Demonstrated ability to identify and resolve technical and procedural problems encountered in laboratory operations.

• Cross-departmental Collaboration: Proven ability to work effectively with diverse teams, including Project Management, scientific staff, and external clients.

• Written and Verbal Communication: Strong written and verbal communication skills for clear documentation, reporting, and client interaction.

• Computer Proficiency: Good general computer skills, with the ability to learn and utilize specialized laboratory software and systems.

Preferred Skills:

• Central Lab/Bioanalytical Lab Experience: Direct experience within a Central Laboratory or Bioanalytical Laboratory setting is highly preferred, providing immediate familiarity with industry practices.

• GxP Knowledge: Understanding of Good Laboratory Practices (GLP) or Good Clinical Practices (GCP) and their implications for laboratory operations.

• Process Improvement: Aptitude for identifying opportunities to improve workflow efficiency and operational processes.

• Oral Presentation Skills: Ability to effectively conduct oral presentations to internal teams and potentially clients.

• Data Analysis: Basic understanding of data analysis principles as they apply to laboratory testing and reporting.

📝 Enhancement Note: The requirement for a Bachelor's degree and 2+ years of experience positions this role as a solid mid-level opportunity for individuals looking to specialize in clinical trial laboratory operations. The emphasis on "regulated clinical/laboratory services environment" strongly suggests experience within GxP settings is crucial. The "Keys to Success" section provides excellent hints for candidates to highlight relevant experiences, such as managing multiple projects, problem-solving in a lab context, and collaborating across teams.

📊 Process & Systems Portfolio Requirements

Portfolio Essentials:

• Protocol Interpretation Case Studies: Examples demonstrating the ability to interpret complex clinical trial protocols and translate them into specific laboratory operational requirements (e.g., sample collection, processing, testing).

• Database Configuration Examples: Showcase of experience in configuring or managing study databases, highlighting attention to detail and understanding of data integrity within a regulated environment.

• Laboratory Specification Documentation: Samples of work on Collection Flow Charts (CFCs), Kit Specifications, or similar operational documents, illustrating clarity, completeness, and adherence to standards.

• Problem-Solving Scenarios: Documentation of challenges encountered in laboratory operations and the systematic approach taken to resolve them, emphasizing analytical skills and process improvement.

Process Documentation:

• Workflow Design: Evidence of designing or optimizing workflows for sample handling, processing, or testing within a laboratory setting.

• System Implementation: Examples of contributing to or managing the implementation of new systems or configurations within a laboratory information system (LIS) or Laboratory Information Management System (LIMS).

• Quality Assurance Documentation: Showcasing an understanding of and contribution to quality assurance processes, including adherence to SOPs and regulatory requirements.

📝 Enhancement Note: For a role involving "Project Design" and "Database Configuration," a portfolio that visually demonstrates the tangible outputs of these tasks is essential. Candidates should prepare to walk through examples of how they've translated a protocol into specific configurations, highlighting the decision-making process and the resulting operational efficiency or accuracy. Portfolio items should emphasize problem-solving and process optimization within a regulated laboratory context.

💵 Compensation & Benefits

Salary Range:

• Based on industry benchmarks for a Project Design Manager I with 2-5 years of experience in the US, a competitive salary range is estimated between $65,000 - $85,000 annually. This estimate considers the specialized nature of clinical laboratory operations, the remote work arrangement, and the GxP-regulated environment. Benefits:

• Comprehensive Health, Dental, and Vision Insurance: Covering medical, vision, and dental needs for employees and their dependents.

• Retirement Savings Plan: Including 401(k) with company match to support long-term financial planning.

• Paid Time Off: Generous vacation, sick leave, and paid holidays to promote work-life balance.

• Life and Disability Insurance: Providing financial security for employees and their families.

• Professional Development Opportunities: Access to training, workshops, and potential tuition reimbursement for continued learning and career advancement.

• Employee Assistance Program (EAP): Offering confidential counseling and support services.

• Potential for Performance Bonuses: Based on individual and company performance. Working Hours:

• Standard business hours, typically Monday through Friday. While the role is remote, adherence to a consistent work schedule is expected to ensure effective collaboration and timely project delivery. Flexibility may be available, but the primary expectation is a 40-hour work week.

📝 Enhancement Note: The salary range is an estimate based on similar roles in the US biotechnology and clinical research sectors. Compensation can vary significantly based on specific experience, the candidate's location within the US (cost of living adjustments may apply), and internal company pay bands. Benefits are standard for a large, established corporation like Thermo Fisher Scientific and are expected to be comprehensive.

🎯 Team & Company Context

🏢 Company Culture

Industry: Biotechnology / Pharmaceutical Services / Life Sciences. Thermo Fisher Scientific is a global leader in serving science, providing a vast range of products and services, including those for clinical research and diagnostics.

Company Size: Large Enterprise (over 10,000 employees). This implies structured processes, extensive resources, and significant career development pathways.

Founded: 1956. With a long history, Thermo Fisher Scientific has established a strong reputation and deep expertise in the scientific and healthcare sectors.

Team Structure:

• Operations Focus: The role is embedded within the PPD® Laboratory Services team, specifically supporting Global Central Laboratories. This team is critical for executing clinical trial testing and analysis.

• Reporting: The Project Design Manager will likely report to a Project Design Lead, Manager, or Director within the Central Labs operations group.

• Collaboration: Close collaboration is expected with Project Managers, laboratory scientists, data management teams, client services, and potentially external clients (sponsors) to ensure seamless study execution.

Methodology:

• Data-Driven Operations: Decisions are informed by protocol requirements, budgetary constraints, and database configurations, emphasizing precision and accuracy.

• Process Standardization: Adherence to Standard Operating Procedures (SOPs) and departmental working practices is paramount, ensuring compliance and consistency.

• Client-Centric Approach: While internal processes are key, the ultimate goal is to meet the specific needs of clinical trial sponsors, requiring a focus on client requirements and satisfaction.

Company Website: Thermo Fisher Scientific Careers

📝 Enhancement Note: Thermo Fisher Scientific's size and global reach mean that operations roles often involve working within established frameworks and contributing to large-scale, impactful projects. The PPD® brand acquisition further solidifies its position in clinical research services, suggesting a culture that values scientific rigor, operational excellence, and client partnership.

📈 Career & Growth Analysis

Operations Career Level: This role represents an early to mid-career stage in clinical operations management. It's a specialized path within laboratory services, distinct from pure project management or scientific research, focusing on the design and setup phase of clinical trials. Successful performance can lead to more senior design roles, specialized project management positions, or team lead opportunities.

Reporting Structure: The Project Design Manager I likely reports to a senior member of the project design or laboratory operations team, providing direct mentorship and oversight. This structure allows for learning from experienced professionals while contributing independently.

Operations Impact: This role has a direct impact on the success of clinical trials by ensuring that the laboratory infrastructure and processes are correctly designed from the outset. Accurate design prevents costly errors, delays, and data integrity issues, ultimately contributing to faster drug development and improved patient outcomes.

Growth Opportunities:

• Specialization: Deepen expertise in specific areas of clinical trial design, such as complex assay configurations, global logistics, or specific therapeutic areas.

• Leadership Development: Progress to Project Design Manager II, Senior Project Design Manager, or Team Lead roles, taking on more complex projects and mentoring junior staff.

• Cross-Functional Mobility: Transition into roles within broader Project Management, Client Services, or Operations Management within Thermo Fisher Scientific's extensive network.

• Technical Skill Enhancement: Develop advanced proficiency in LIMS/LIS systems, data analysis tools, and project management software.

• Industry Certifications: Pursue certifications relevant to clinical research or project management to further enhance credentials.

📝 Enhancement Note: The progression from "Project Design Manager I" suggests a structured career path. Candidates should inquire about formal training programs, mentorship opportunities, and the typical career trajectory for individuals excelling in this role within Thermo Fisher Scientific's operations division.

🌐 Work Environment

Office Type: Fully Remote. This role operates entirely outside a traditional office setting, requiring self-discipline and effective remote work practices.

Office Location(s): While the role is remote, candidates must be legally authorized to work in the United States, and applicants from all locations within the US are welcomed. This suggests the company has established processes for remote onboarding and management across different US time zones.

Workspace Context:

• Independent Workstation: The employee is responsible for maintaining a suitable, dedicated workspace that allows for focused work and adherence to data privacy and security standards.

• Technology Reliance: Heavy reliance on company-provided or approved hardware and software, including secure internet connectivity, for communication, collaboration, and system access.

• Virtual Collaboration: Daily interaction with colleagues will occur via video conferencing, instant messaging, and email, necessitating strong virtual communication skills.

Work Schedule: Standard business hours (Monday-Friday). While remote, maintaining a consistent schedule is crucial for team coordination, client responsiveness, and project timelines. Occasional flexibility may be required for international client calls or urgent project needs.

📝 Enhancement Note: As a fully remote role, the emphasis shifts to the candidate's ability to self-manage, maintain productivity, and effectively collaborate in a virtual environment. Candidates should be prepared to discuss their remote work setup and strategies for staying connected and engaged with their team.

📄 Application & Portfolio Review Process

Interview Process:

• Initial Screening: Typically involves an HR or recruiter call to assess basic qualifications, interest, and cultural fit.

• Hiring Manager Interview: A deeper dive into experience, technical skills, and understanding of clinical lab operations and project design principles. Expect behavioral questions related to past projects and problem-solving.

• Team/Peer Interviews: Interviews with potential colleagues or team leads to evaluate collaboration style, technical aptitude, and fit within the team dynamic.

• Case Study/Presentation: A common element for design roles. Candidates may be asked to analyze a sample protocol or operational challenge and present their proposed design or solution, demonstrating their analytical and communication skills.

• Final Interview: May involve a senior leader to confirm fit and discuss overall career aspirations.

Portfolio Review Tips:

• Curate for Relevance: Select 3-5 key projects that best showcase your ability to interpret protocols, design lab specifications, manage configurations, and solve operational problems.

• Quantify Impact: Wherever possible, use metrics to demonstrate the positive outcomes of your work (e.g., "reduced processing errors by X%", "improved turnaround time by Y%", "successfully managed Z number of concurrent studies").

• Structured Narratives: For each project, clearly articulate the challenge, your approach, the solutions implemented, and the results achieved. Use the STAR method (Situation, Task, Action, Result).

• Visual Aids: If possible, use anonymized examples of CFCs, kit specs, or database layouts (ensuring no confidential information is shared) to illustrate your technical capabilities.

• Process Focus: Emphasize the process you followed, not just the final output. This demonstrates your understanding of methodology and quality control.

Challenge Preparation:

• Protocol Analysis: Practice breaking down a hypothetical clinical trial protocol into key laboratory requirements. Identify potential challenges or areas needing design clarification.

• System Configuration Logic: Be prepared to discuss your thought process for configuring systems like CFCs or kit specs. Understand variables like sample stability, testing frequency, and assay types.

• Stakeholder Communication: Practice articulating technical designs and operational plans clearly and concisely to both technical and non-technical audiences.

• Problem-Solving Scenarios: Prepare to discuss how you would troubleshoot common issues in clinical lab operations or database design.

📝 Enhancement Note: The interview process for a role like this will heavily scrutinize the candidate's practical application of their knowledge. A strong portfolio that can be effectively presented and discussed during interviews is crucial for success. Candidates should anticipate questions that probe their understanding of GxP principles and their ability to manage complexity in a regulated environment.

🛠 Tools & Technology Stack

Primary Tools:

• Laboratory Information Management Systems (LIMS) / Laboratory Information Systems (LIS): Proficiency with systems used for managing sample tracking, testing, results, and reporting in a clinical laboratory setting. Specific systems used by Thermo Fisher Scientific may include their proprietary platforms or widely adopted industry solutions.

• Database Management Software: Familiarity with database principles and potentially specific database tools (e.g., SQL, Oracle) for understanding and configuring study databases.

• Project Management Software: Experience with tools like Microsoft Project, Asana, Smartsheet, or similar platforms for task management, scheduling, and collaboration.

• Microsoft Office Suite: Advanced proficiency in Word, Excel, PowerPoint, and Outlook for documentation, data analysis, presentations, and communication.

Analytics & Reporting:

• Excel (Advanced): For data manipulation, basic analysis, and creating reports. Experience with pivot tables, VLOOKUP, and data visualization capabilities is beneficial.

• Data Visualization Tools (Basic Awareness): Familiarity with tools like Tableau or Power BI is a plus, though not explicitly required, for understanding how data is presented.

CRM & Automation:

• CRM Systems (Awareness): Understanding how clinical trial data and client interactions are managed within a CRM context, even if not directly using one in this role.

• Workflow Automation Tools (Basic Awareness): Familiarity with concepts of automating repetitive tasks, which may be indirectly relevant to designing efficient laboratory workflows.

📝 Enhancement Note: While specific LIMS/LIS names are not provided, candidates should highlight any experience with systems that manage clinical trial sample workflows, testing menus, and result reporting. Advanced Excel skills are a must for data handling and analysis in this role.

👥 Team Culture & Values

Operations Values:

• Accuracy & Quality: A paramount focus on precision, data integrity, and adherence to quality standards in all aspects of design and configuration.

• Collaboration & Teamwork: A strong emphasis on working together across departments and with clients to achieve shared goals.

• Accountability & Ownership: Taking responsibility for assigned tasks, projects, and deliverables, demonstrating reliability and commitment.

• Innovation & Continuous Improvement: Encouraging new ideas and methods to enhance efficiency, accuracy, and client satisfaction within laboratory operations.

• Integrity & Ethics: Upholding the highest ethical standards in all professional conduct, particularly within the regulated clinical research environment.

Collaboration Style:

• Cross-functional Integration: Actively engages with Project Managers, scientific staff, and client services to ensure seamless study design and execution.

• Open Communication: Fosters an environment where ideas, concerns, and feedback can be shared openly and constructively.

• Proactive Engagement: Takes initiative to seek input, clarify requirements, and anticipate potential issues to facilitate smooth project progression.

• Client Partnership: Works collaboratively with clients to understand their needs and translate them into effective laboratory solutions.

📝 Enhancement Note: Thermo Fisher Scientific, as a large and reputable organization, likely fosters a culture that balances robust process adherence with a forward-thinking approach to scientific advancement. Candidates should emphasize their ability to thrive in a structured yet dynamic environment where collaboration and quality are core tenets.

⚡ Challenges & Growth Opportunities

Challenges:

• Protocol Complexity: Interpreting highly complex or ambiguous clinical trial protocols that may require extensive clarification or creative problem-solving to translate into laboratory specifications.

• Conflicting Requirements: Balancing competing demands from different stakeholders (e.g., sponsor, regulatory bodies, internal operations) to create a design that is both compliant and efficient.

• System Limitations: Working within the constraints of existing LIMS/LIS platforms, requiring innovative configuration solutions to meet unique study needs.

• Rapidly Changing Protocols: Adapting to protocol amendments or changes mid-study, which necessitates quick and accurate re-configuration of databases and specifications.

• Remote Collaboration: Maintaining strong team cohesion and effective communication in a fully remote environment.

Learning & Development Opportunities:

• Advanced LIMS/LIS Training: Opportunities to become an expert in specific laboratory information systems used by Thermo Fisher Scientific.

• Clinical Trial Design Specialization: Deepening knowledge in areas like biomarker testing, specialized assay requirements, or global sample logistics.

• Project Leadership: Developing skills to lead more complex projects, manage larger teams, or mentor junior design managers.

• Industry Conferences & Webinars: Participation in events to stay abreast of advancements in clinical trial methodology, laboratory technology, and regulatory updates.

• Internal Training Programs: Access to Thermo Fisher's comprehensive learning and development resources, including leadership training and technical skill enhancement courses.

📝 Enhancement Note: Candidates should demonstrate an awareness of these challenges and frame them as opportunities for growth and skill development. Proactively seeking solutions and adapting to change are key attributes for success in this role.

💡 Interview Preparation

Strategy Questions:

• Protocol Interpretation: "Describe a time you had to interpret a particularly complex or ambiguous clinical trial protocol. What were the key challenges, and how did you ensure all laboratory requirements were accurately captured?" (Focus on your systematic approach and critical thinking.)

• Database Design Logic: "Walk me through your process for configuring a Collection Flow Chart (CFC) for a multi-site, multi-assay clinical trial. What factors do you consider most critical?" (Highlight your understanding of variables and their impact.)

• Problem-Solving in Operations: "Tell me about a time a laboratory process or database configuration you designed encountered an unexpected issue. How did you identify the root cause, and what steps did you take to resolve it?" (Emphasize your analytical skills and resolution process.)

Company & Culture Questions:

• Thermo Fisher Values: "How do you see your approach to work aligning with Thermo Fisher Scientific's mission to enable customers to make the world healthier, cleaner, and safer?" (Connect your work to the broader impact.)

• Remote Teamwork: "How do you ensure effective communication and collaboration with team members and stakeholders when working remotely?" (Discuss your strategies for virtual engagement.)

• Quality in Operations: "In a regulated environment like clinical trials, how do you prioritize quality and accuracy in your design work?" (Showcase your commitment to GxP principles.)

Portfolio Presentation Strategy:

• Concise Storytelling: For each portfolio item, clearly state the project objective, your specific role, the actions you took, and the measurable results.

• Visual Clarity: Use clear, well-organized slides or documents. Highlight key elements like protocol requirements, design decisions, and final outputs.

• Focus on Process: Explain why you made certain design choices, demonstrating your understanding of the underlying principles and potential impacts.

• Stakeholder Perspective: Be prepared to discuss how your design choices would benefit different stakeholders (e.g., project managers, lab technicians, clients).

• Q&A Readiness: Anticipate questions about your design choices, potential alternatives, and how you would handle challenges or changes.

📝 Enhancement Note: Candidates should prepare specific examples from their past experience that directly map to the responsibilities and required skills for this role. The ability to articulate their thought process and demonstrate a problem-solving mindset will be key differentiators.

📌 Application Steps

To apply for this operations position:

• Submit your application through the Thermo Fisher Scientific Careers portal using the provided link.

• Resume Optimization: Tailor your resume to highlight experience in clinical trial protocols, laboratory operations, database configuration, and project design. Use keywords from the job description and quantify your achievements with metrics.

• Portfolio Preparation: Curate a selection of 3-5 projects that best demonstrate your skills in protocol interpretation, laboratory specification development, and problem-solving within a regulated environment. Prepare to discuss these in detail.

• Interview Practice: Rehearse answers to common interview questions, focusing on behavioral examples using the STAR method. Practice articulating your technical knowledge and project design approach clearly.

• Company Research: Familiarize yourself with Thermo Fisher Scientific's mission, values, and its role in the life sciences and clinical research sectors. Understand the significance of PPD® Laboratory Services.

⚠️ Important Notice: This enhanced job description includes AI-generated insights and operations industry-standard assumptions. All details should be verified directly with the hiring organization before making application decisions.