Temp, Project Design Manager

📍 Job Overview

Job Title: Temp, Project Design Manager Company: LabConnect Location: Johnson City, Tennessee, United States Job Type: Temporary Category: Clinical Operations / Project Management Date Posted: 2026-02-20 Experience Level: 3-6 years Remote Status: On-site

🚀 Role Summary

• Manages the end-to-end setup and amendment lifecycle for clinical trial projects, ensuring seamless integration of client requirements into operational deliverables.
• Develops and revises critical operational documents, including Operational Specification Documents (OSDs), customized test requisitions, laboratory manuals, and collection kit specifications, with a strong focus on accuracy and client adherence.
• Acts as a subject matter expert (SME) and primary liaison for sponsors and Contract Research Organizations (CROs), facilitating clear communication and driving project timelines.
• Coordinates effectively with internal functional departments to ensure accurate database setup and successful execution of study needs, fostering cross-functional alignment.
• Contributes to process efficiency and the maintenance of quality standards by identifying and implementing improvements in project initiation and execution.

📝 Enhancement Note: While the title "Project Design Manager" might suggest a focus on product or service design, the description clearly indicates this role is deeply embedded within clinical trial operations. The "design" aspect refers to the operational setup and documentation design for clinical studies. This role requires a blend of project management, operational documentation expertise, and client-facing communication within the pharmaceutical and biotech research sector.

📈 Primary Responsibilities

• Clinical Trial Project Setup & Amendments:
  • Spearhead the initial setup and subsequent amendments for clinical trial projects, ensuring all client requirements are meticulously captured and implemented.
  • Create or revise Operational Specification Documents (OSDs) to accurately define study protocols and client needs for trials of varying complexity.
  • Develop and update customized test requisitions, laboratory manuals, and collection kit specifications to align with specific study requirements.
• Client and Stakeholder Management:
  • Serve as a key point of contact for Sponsors and Contract Research Organizations (CROs), maintaining robust communication channels and ensuring adherence to project timelines and deliverables.
  • Participate actively in internal and external calls as a Subject Matter Expert (SME) for project initiation, providing critical information to Project Managers and other stakeholders.
  • Deliver regular status updates on setup progress to Project Management and Client Services leadership, ensuring transparency and proactive issue management.
• Cross-Functional Coordination:
  • Interface with various internal functional departments (e.g., IT, laboratory operations, logistics) to facilitate database setup and communicate specific study needs effectively.
  • Liaise with colleagues across departments to confirm the timely completion of all setup-related tasks, ensuring a cohesive and efficient workflow.
• Process Improvement & Documentation:
  • Translate complex client requirements into actionable steps for problem-solving and issue resolution, often requiring innovative solutions that still adhere to internal standards.
  • Understand and interpret project-specific budgets to ensure operational setups are financially aligned with study parameters.
  • Assist in the creation and oversight of training materials, templates, job aids, and Standard Operating Procedures (SOPs) to standardize processes and knowledge transfer.
• Training and Mentorship:
  • Support project-specific training initiatives for internal staff, ensuring consistent understanding and application of study requirements.
  • Mentor and train new team members to facilitate knowledge transfer and reinforce best practices in project setup and management.

📝 Enhancement Note: The responsibilities highlight a critical operational role focused on the foundational setup of clinical trials. This goes beyond basic project coordination; it involves deep understanding of study design, regulatory documentation, and client-specific needs within the highly regulated pharmaceutical and clinical research industry. The emphasis on OSDs, requisitions, and manuals points to a need for meticulous document control and attention to detail.

🎓 Skills & Qualifications

Education:

• Bachelor's degree (B.A./B.S.) from an accredited institution, OR
• Associate's degree (A.S.) from an accredited institution.
• Equivalent combination of education and relevant experience will be considered.

Experience:

• Minimum of 3 years of direct setup-related experience OR project management experience in a relevant field.
• For those with an Associate's degree, a minimum of 5-6 years of experience in central laboratory or related clinical research is required, with at least 3 of those years being setup-related or project management experience.
• Experience gained outside of LabConnect in clinical research, central laboratory services, or project management is valued.

Required Skills:

• Operational Document Creation: Proven ability to create and revise complex operational documents such as Operational Specification Documents (OSDs), test requisitions, and laboratory manuals.
• Clinical Trial Setup Expertise: Demonstrated experience in managing the setup phase of clinical trials, understanding the intricacies of study design and execution from an operational perspective.
• Client Requirement Translation: Strong capability to interpret and translate client needs into actionable project requirements and operational plans.
• Cross-Functional Collaboration: Experience working effectively with diverse internal teams (e.g., IT, operations, client services) to achieve project goals.
• Problem-Solving & Decision Making: Ability to analyze situations, identify practical solutions, and make well-thought-out decisions, adapting to changing requirements.
• Organizational & Time Management: Excellent skills in planning, prioritizing tasks, and managing workload to meet established timelines and procedures.
• Communication Skills: Exceptional verbal and written communication abilities, including active listening, clear articulation of needs, and effective presentation of information to internal and external stakeholders.
• Customer Service Orientation: Proven experience in customer service, with a strong focus on client relationship management and meeting client expectations.
• Microsoft Office Proficiency: Working knowledge of Microsoft Office Suite, including Word, Excel, and PowerPoint, for document creation, data analysis, and presentations.

Preferred Skills:

• Central Laboratory Operations: Direct experience within a central laboratory environment, understanding its specific workflows and operational demands.
• Clinical Research Industry Knowledge: Familiarity with the pharmaceutical and biotechnology sectors, including Contract Research Organizations (CROs) and their operational needs.
• Budget Management: Experience with project-specific budgets, including understanding and interpreting financial parameters for clinical trials.
• Process Improvement Methodologies: Familiarity with identifying inefficiencies and suggesting improvements to operational processes.
• SOP Development: Experience in developing or contributing to the creation of Standard Operating Procedures (SOPs) and training materials.

📝 Enhancement Note: The experience requirements are structured to accommodate different educational backgrounds, emphasizing practical, setup-related, or project management experience within the clinical research or central lab domain. The required skills are heavily weighted towards operational execution, documentation, client interaction, and internal coordination, which are critical for a role managing the "design" or setup phase of clinical trials.

📊 Process & Systems Portfolio Requirements

Portfolio Essentials:

• Operational Specification Document (OSD) Samples: Showcase examples of OSDs you have developed or significantly contributed to, demonstrating your ability to translate complex study protocols into clear, actionable operational requirements. Highlight any amendments you managed and the outcome.
• Customized Requisition/Manual Examples: Include samples of customized test requisitions, laboratory manuals, or collection kit specifications you have designed, illustrating your attention to detail and understanding of specific testing and sample collection needs.
• Project Setup Case Studies: Present 1-2 concise case studies detailing clinical trial projects you managed from setup through initiation. Focus on challenges faced, your problem-solving approach, cross-functional coordination efforts, and the successful outcome in terms of timeline adherence and client satisfaction.
• Process Improvement Examples: If applicable, provide examples of process improvements you identified and implemented within project setup or documentation workflows, quantifying the impact (e.g., time saved, error reduction).

Process Documentation:

• Workflow Design & Optimization: Demonstrate experience in mapping out and documenting project setup workflows, identifying bottlenecks, and proposing optimized sequences for efficiency.
• Implementation & Automation: Showcase understanding of how to implement new processes or leverage existing systems for efficient task completion, even if direct automation experience is limited.
• Measurement & Performance Analysis: Explain how you would track the progress of project setups and use data (even if qualitative) to inform improvements or report on performance against timelines.

📝 Enhancement Note: For a role like this, a portfolio is crucial. It should not just list responsibilities but provide tangible evidence of how the candidate has executed them. Focus on showcasing the quality and thoroughness of operational documents and the effectiveness of their project initiation management. Demonstrating how they translate client needs into detailed operational plans is key.

💵 Compensation & Benefits

Salary Range:

• Estimated Range: $60,000 - $85,000 annually.
• Explanation: This estimate is based on industry benchmarks for Project Design Managers or Clinical Trial Setup Specialists with 3-6 years of experience in the pharmaceutical/biotech services sector, located in a mid-sized US city like Johnson City, TN. The temporary nature of the assignment may influence the final compensation, potentially leading to a higher hourly rate than a permanent role at the same level. Actual compensation will be determined by experience, qualifications, and internal equity.

Benefits:

• Financial Security:
  • Competitive Base Pay
  • 401k Match program
  • Potential for Annual Bonus Eligibility
• Health & Wellness:
  • Comprehensive Health Benefits available from the date of hire.
  • Paid Time Off (PTO) plan.
  • 11 Paid Company Holidays.
  • 1 Paid Volunteer Day to support community initiatives.
• Insurance Coverage:
  • Short-Term Disability
  • Long-Term Disability
  • Life Insurance
  • Accidental Death & Dismemberment (AD&D) Insurance
• Professional Development:
  • Opportunities for career growth within a global organization.
  • Investment in employee development and learning.

Working Hours:

• Standard Hours: Monday to Friday, 8:00 a.m. to 5:00 p.m. EST.
• Total Hours: Approximately 40 hours per week.
• Flexibility: While the role is on-site and has set hours, the nature of clinical operations may occasionally require flexibility to meet critical client deadlines or project milestones.

📝 Enhancement Note: Given this is a temporary assignment, the salary range is estimated to reflect that. Benefits are comprehensive, with a strong emphasis on health and insurance, which is common for roles in the healthcare and pharmaceutical industries. The inclusion of a volunteer day and emphasis on company values suggests a supportive and community-oriented work environment.

🎯 Team & Company Context

🏢 Company Culture

Industry: Central Laboratory Services & Functional Service Provider (FSP) Solutions for Pharmaceutical, Biotech, and Clinical Research Organizations (CROs). Company Size: LabConnect is a growing global organization, with a significant presence across multiple locations, serving a substantial client base. While exact employee numbers aren't provided, the description suggests a mid-to-large-sized company within the specialized clinical research services sector. This size indicates established processes yet retains agility. Founded: LabConnect was founded to provide a specialized, one-stop-shop for central laboratory services, aiming to accelerate drug development. The company's focus on innovation, agility, and collaboration is a core part of its identity.

Team Structure:

• Operations Focus: This role sits within a team responsible for the critical initial setup and ongoing management of clinical trial projects. The team likely comprises Project Managers, Project Coordinators, and other operational specialists.
• Reporting: The Temp, Project Design Manager will likely report to a Project Management lead or a Client Services Manager, with regular updates also provided to senior leadership.
• Cross-Functional Collaboration: The role demands close collaboration with various internal departments, including IT (for database setup), laboratory operations, logistics, client services, and potentially quality assurance teams. External collaboration with Sponsors and CROs is also a key aspect.

Methodology:

• Client-Centric Approach: LabConnect emphasizes a "Customer Centered" value, meaning project design and execution are heavily influenced by client requirements and study needs.
• Quality & Process Driven: "Quality Focused" and "Accountability Always" values underscore a commitment to adhering to strict standards, procedures, and documentation protocols inherent in clinical research.
• Agility & Innovation: The company positions itself as agile and innovative, suggesting an environment where efficient processes are valued, but adaptability to evolving study demands is also crucial.

Company Website: https://www.labconnect.com/

📝 Enhancement Note: LabConnect operates in a highly regulated and specialized sector of the pharmaceutical industry. The company culture is built around its mission to advance clinical trials, emphasizing core values like "People First," "Quality Focused," "Customer Centered," "Technology Driven," and "Accountability Always." This suggests a professional, results-oriented environment where attention to detail and client satisfaction are paramount.

📈 Career & Growth Analysis

Operations Career Level: This role is positioned as an intermediate-level position within clinical operations project management. It requires specialized knowledge of clinical trial setup processes and operational documentation, making it a key contributor to the successful initiation of studies. It bridges the gap between administrative support and full-scale project management.

Reporting Structure: The Temp, Project Design Manager will report to a Project Management or Client Services leader. This provides exposure to senior operational decision-making and strategic project oversight. The role also requires significant interaction with project managers and client services teams, offering insights into broader project management functions.

Operations Impact: This role has a direct and critical impact on LabConnect's ability to serve its clients and, by extension, accelerate the development of new medicines. By accurately translating client requirements into operational plans and ensuring seamless project initiation, this position directly contributes to:

• Client Satisfaction: Ensuring clients receive accurate and timely setup, fostering strong relationships.
• Operational Efficiency: Laying the groundwork for smooth study execution, minimizing delays and errors.
• Revenue Generation: Facilitating the onboarding of new clinical trials, which is essential for business growth.
• Data Integrity: Ensuring that study protocols are correctly translated into laboratory processes, which is fundamental for reliable clinical trial data.

Growth Opportunities:

• Specialization: Deepen expertise in clinical trial setup, operational documentation, and client management within the central laboratory services domain.
• Project Management Proficiency: Develop advanced project management skills through exposure to diverse trial complexities and interactions with experienced Project Managers. The company's emphasis on mentorship can facilitate this.
• Cross-Functional Mobility: Gain a comprehensive understanding of various operational departments within LabConnect, potentially leading to opportunities in broader project management, client services, or operational strategy roles.
• Temporary to Permanent Transition: While a temporary role, exceptional performance could lead to opportunities for permanent positions within LabConnect, especially if the need for such expertise is ongoing.

📝 Enhancement Note: This role offers a valuable stepping stone for professionals looking to specialize in the operational initiation of clinical trials. The temporary nature means candidates should be motivated by the specific project and the experience gained, with a potential for conversion being a significant motivator. The emphasis on mentorship suggests a supportive environment for skill development.

🌐 Work Environment

Office Type: The role is on-site in Johnson City, TN, indicating a traditional office-based work environment. This typically involves desks, cubicles, or shared office spaces designed for focused work and collaboration. Office Location(s): Johnson City, Tennessee. This location is specified for the role, suggesting a dedicated operational hub for LabConnect in this region.

Workspace Context:

• Focused Work: The environment will support individual concentration required for document creation, data analysis, and detailed planning.
• Collaborative Spaces: Access to meeting rooms and common areas will be available for internal and external calls, team discussions, and cross-functional meetings.
• Technology Infrastructure: Expected to have standard office technology, including computers, reliable internet access, and communication tools (phones, video conferencing) necessary for client interactions and internal coordination.
• Team Interaction: Opportunities for direct interaction with colleagues, project managers, and leadership, fostering a collaborative and supportive work atmosphere aligned with LabConnect's values.

Work Schedule:

• Standard Hours: Monday through Friday, 8:00 AM to 5:00 PM EST, totaling approximately 40 hours per week.
• Adherence to Timelines: While a structured schedule is provided, the dynamic nature of clinical trial operations means occasional flexibility may be required to meet critical project deadlines or urgent client requests. This ensures that project initiation milestones are consistently met.

📝 Enhancement Note: The on-site requirement in Johnson City, TN, is a key factor for candidates. The description of the workspace implies a professional setting conducive to both focused document work and collaborative problem-solving, typical of operations roles in regulated industries.

📄 Application & Portfolio Review Process

Interview Process:

• Initial Screening: A recruiter or hiring manager will likely conduct an initial phone screen to assess basic qualifications, experience, and interest in the temporary role.
• Hiring Manager Interview: A more in-depth interview with the direct hiring manager to evaluate technical skills, operational knowledge, problem-solving abilities, and cultural fit. This is where your understanding of clinical trial setup and documentation will be key.
• Team/Cross-Functional Interview: Potentially an interview with members of the operations team or key stakeholders you would collaborate with. This assesses your ability to work collaboratively and communicate effectively across departments.
• Portfolio Review: A dedicated session to walk through your portfolio. Be prepared to discuss specific examples of OSDs, requisitions, and project setup case studies.
• Final Offer: Based on the cumulative assessment of your qualifications and fit.

Portfolio Review Tips:

• Curate Selectively: Choose 3-5 strong examples that best represent your skills in operational document creation and project setup management. Quality over quantity.
• Structure Your Case Studies: For each case study, clearly outline:
  • The Challenge: What were the client's needs or the study's complexity?
  • Your Role & Actions: What specific steps did you take in designing/setting up the project?
  • Collaboration: How did you work with internal teams and external clients?
  • The Outcome: What was the result? (e.g., successful setup, on-time initiation, positive client feedback, process improvement).
• Quantify Impact: Where possible, use numbers to demonstrate your achievements (e.g., "reduced setup time by X%", "managed setup for Y complex trials," "handled Z client inquiries").
• Explain Your Thought Process: Be ready to articulate why you made certain decisions in your documentation or setup process. This demonstrates critical thinking.
• Highlight Adaptability: Showcase instances where you had to adapt to changing client requirements or unforeseen challenges during setup.

Challenge Preparation:

• Scenario-Based Questions: Expect questions that present hypothetical situations related to clinical trial setup, client communication, or cross-functional coordination. Prepare to answer using the STAR method (Situation, Task, Action, Result).
• Document Review Exercise: You might be given a sample study protocol or client request and asked to outline the key components of an OSD or relevant documentation you would create.
• Process Mapping: Be prepared to describe how you would map out a project setup process or identify areas for improvement.

📝 Enhancement Note: The interview process will likely be rigorous, given the critical nature of this role in clinical research. Candidates should be prepared to demonstrate not only their technical skills in documentation and setup but also their ability to manage client expectations and collaborate effectively within a regulated environment. A well-prepared, evidence-based portfolio is essential.

🛠 Tools & Technology Stack

Primary Tools:

• Microsoft Office Suite: Essential for daily tasks, including Word for document creation, Excel for data management and budget tracking, and PowerPoint for presentations and internal updates.
• Project Management Software (Likely): While not explicitly named, companies in this sector often use tools like Microsoft Project, Asana, Jira, or specialized clinical trial management systems (CTMS) for tracking project progress, timelines, and tasks. Familiarity with at least one is beneficial.
• Communication Platforms: Standard tools for internal and external communication, such as email (Outlook), instant messaging (Teams, Slack), and video conferencing (Zoom, Teams, Webex).

Analytics & Reporting:

• Excel: For basic data analysis, budget tracking, and creating simple reports.
• Internal Databases/CRMs: LabConnect likely uses an internal system for managing client information, study details, and project status. Familiarity with navigating and inputting data into such systems is key.

CRM & Automation:

• CRM/Client Management Systems: Experience with systems used to manage client interactions and project data is advantageous, even if LabConnect uses a proprietary tool.
• Document Management Systems: Familiarity with systems for document control, versioning, and archiving, crucial for maintaining compliance in a regulated industry.

📝 Enhancement Note: Proficiency in Microsoft Office is a baseline requirement. Given the role's focus on project setup and documentation, experience with document management systems and any form of project tracking or CRM software would be highly beneficial. Candidates should be prepared to articulate their comfort level with learning new systems quickly.

👥 Team Culture & Values

Operations Values:

• Accountability Always: This value translates to taking ownership of project setup tasks, ensuring accuracy, and seeing them through to completion with a high degree of responsibility.
• Quality Focused: A commitment to meticulous detail in creating operational documents (OSDs, requisitions, manuals) to prevent errors and ensure compliance with study protocols and regulatory standards.
• Customer Centered: Prioritizing client needs and requirements, ensuring clear communication and accurate translation of their requests into operational plans that meet or exceed expectations.
• Technology Driven: An openness to leveraging technology to improve efficiency in documentation, communication, and project tracking, and understanding how systems support operational workflows.
• People First: While focused on operational tasks, demonstrating respect, collaboration, and support for colleagues within the project setup team and across departments.

Collaboration Style:

• Proactive Communication: Regularly updating stakeholders (Project Managers, Client Services, Sponsors, CROs) on setup progress, potential issues, and resolutions.
• Cross-Functional Partnership: Working closely with IT, lab operations, and logistics to ensure all components of the project setup are aligned and executed seamlessly.
• Feedback Integration: Being open to feedback on documentation and processes from team members and clients to foster continuous improvement.
• Knowledge Sharing: Contributing to the creation of training materials and SOPs, and actively participating in mentoring new team members to ensure consistent application of best practices.

📝 Enhancement Note: LabConnect's stated values provide a clear framework for the expected team culture. Candidates should align their responses and behaviors with these values, demonstrating a commitment to quality, client focus, and teamwork within the operational context of clinical trial setup.

⚡ Challenges & Growth Opportunities

Challenges:

• Translating Complex Protocols: Accurately interpreting intricate clinical study protocols and client-specific requests into clear, comprehensive operational documents can be challenging.
• Managing Multiple Stakeholders: Balancing the needs and expectations of internal departments, sponsors, and CROs simultaneously while adhering to strict timelines.
• Dynamic Requirements: Clinical trial needs can evolve, requiring adaptability and the ability to manage amendments efficiently without compromising quality or timelines.
• Temporary Assignment Constraints: Working within a defined timeframe (12 months) requires rapid integration, high productivity, and a focus on delivering immediate value.

Learning & Development Opportunities:

• Clinical Operations Specialization: Gaining in-depth experience in the operational setup phase of clinical trials, a critical and specialized area of the CRO/pharma industry.
• Document Control & Compliance: Enhancing skills in creating and managing highly regulated documentation, which is transferable across many roles in life sciences.
• Cross-Functional Exposure: Understanding the interdependencies between various operational departments (e.g., IT, logistics, lab services) within a global clinical research organization.
• Mentorship & Training: Learning from experienced professionals and potentially contributing to training materials, solidifying knowledge and developing leadership potential.
• Industry Best Practices: Gaining practical experience with industry standards and best practices in clinical trial management and central laboratory services.

📝 Enhancement Note: The temporary nature of the role presents both a challenge (need for rapid impact) and an opportunity (focused, intensive learning experience). Candidates should highlight their ability to adapt quickly and their eagerness to contribute within a defined period.

💡 Interview Preparation

Strategy Questions:

• Scenario-Based: "Describe a time you had to translate a complex client request into operational requirements. What was the process, and what was the outcome?" (Focus on your documentation process, client communication, and problem-solving).
• Process-Oriented: "How would you approach creating an Operational Specification Document (OSD) for a new clinical trial? What key information would you gather, and who would you involve?" (Demonstrate your understanding of the setup workflow and cross-functional needs).
• Problem-Solving: "Imagine a critical setup task is delayed due to an internal team's capacity issue. How would you address this to ensure the overall project timeline remains on track?" (Highlight your communication, negotiation, and proactive problem-solving skills).

Company & Culture Questions:

• Values Alignment: "LabConnect values 'Accountability Always' and 'Quality Focused.' Can you provide an example from your experience that demonstrates these values?" (Connect your past actions to their stated values).
• Teamwork: "How do you ensure effective collaboration with different departments when working on project setups?" (Discuss your communication strategies and experience with cross-functional teams).
• Client Focus: "Describe your approach to managing client expectations during the project setup phase." (Emphasize your client service skills and communication techniques).

Portfolio Presentation Strategy:

• "Show, Don't Just Tell": For each portfolio item (OSD, case study), walk the interviewer through it. Explain the context, your specific contributions, the decisions you made, and the results.
• Highlight Key Sections: For OSDs, point out sections where you demonstrated critical thinking, translation of complex requirements, or problem-solving.
• Quantify Success: For case studies, clearly state the project's scope, your role, and the quantifiable outcomes (e.g., timeline adherence, client satisfaction).
• Tailor to the Role: Emphasize how your portfolio examples directly relate to the responsibilities of a Temp, Project Design Manager, focusing on setup, documentation, and client liaison.
• Prepare for Questions: Anticipate questions about your process, decisions, and challenges related to the examples you present.

📝 Enhancement Note: Preparation should focus on demonstrating a strong understanding of clinical trial operations, meticulous documentation skills, effective communication, and a proactive, problem-solving mindset. The portfolio is your primary tool to showcase practical application of these skills.

📌 Application Steps

To apply for this operations position:

• Submit your application through the provided application link on Dayforce.
• Portfolio Customization: Review your professional portfolio. Select 2-3 of your strongest examples of operational documents (e.g., OSDs, requisitions) and 1-2 concise case studies detailing successful project setups. Ensure these clearly demonstrate your ability to translate client requirements into actionable operational plans.
• Resume Optimization: Tailor your resume to highlight keywords and responsibilities directly related to clinical trial setup, project management, operational document creation, client liaison, and cross-functional coordination. Quantify achievements wherever possible.
• Interview Preparation: Practice articulating your experience using the STAR method for behavioral questions. Prepare to discuss your portfolio items in detail and demonstrate your understanding of LabConnect's values and the clinical research industry.
• Company Research: Thoroughly review the LabConnect website, focusing on their services, mission, and core values. Understand their role in the pharmaceutical and biotech landscape. This will help you tailor your responses and demonstrate genuine interest.

⚠️ 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.