Project Design Manager I

📍 Job Overview

Job Title: Project Design Manager I

Company: ClinClinicaLink (Clinical Ink)

Location: Remote (United States)

Job Type: Full-Time

Category: Clinical Operations / GTM Operations (Clinical Trial Technology)

Date Posted: June 1, 2026

Experience Level: Mid-Level (2-5 years)

Remote Status: Fully Remote

🚀 Role Summary

• Translate complex clinical trial protocols into actionable system requirements for Direct Data Capture (DDC) and electronic Clinical Outcome Assessment (eCOA) platforms.

• Lead and manage the end-to-end study build process, from initial protocol review to final User Acceptance Testing (UAT) sign-off.

• Drive cross-functional collaboration between internal teams (e.g., Study Operations, Project Management, Clinical Programming) and external stakeholders (clients) to ensure successful system implementation and data precision.

• Define, configure, and validate system functionalities, form content, metadata, and data export requirements, adhering to regulatory guidelines and industry best practices.

📝 Enhancement Note: While the title is "Project Design Manager I," the responsibilities clearly indicate a role focused on the operational execution of clinical trial technology builds, bridging the gap between protocol design and system configuration. This aligns with GTM Operations and Clinical Operations roles that ensure technology solutions effectively support trial execution. The "I" designation suggests an entry to mid-level position within this specialized domain.

📈 Primary Responsibilities

• Protocol Interpretation & Requirement Definition:

  • Thoroughly review client protocols and supporting documentation to understand study objectives, data collection needs, and regulatory requirements.
  • Translate complex protocol specifications into detailed system requirements for eCOA builds, including application configuration, form content, metadata, and specific functionalities.
  • Ensure all system requirements align with data export needs, applicable regulatory guidelines (e.g., FDA 21 CFR Part 11), and the capabilities of the DDC and eCOA platforms.

• Study Build Oversight & Management:

  • Oversee and execute the build of eCOA systems, with managerial support as needed.
  • Collaborate with Study Operations Leads to identify resource requirements and manage the study build timeline effectively.
  • Proactively update study requirements throughout the design and build lifecycle as protocol amendments or client feedback necessitates.

• Client & Internal Collaboration:

  • Lead client-facing meetings to present study designs, gather feedback, and ensure alignment on system functionality and user experience.
  • Conduct internal meetings with cross-functional teams (Project Management, Project Data Management, Clinical Programming) to discuss study build progress, scope, and timelines.
  • Facilitate communication with Project Data Management and Clinical Programming to confirm that data mapping and export requirements are accurately met.

• Quality Assurance & Testing:

  • Perform internal User Acceptance Testing (UAT) to validate system functionality, data integrity, and adherence to requirements.
  • Lead client UAT processes, including creating UAT databases and entry forms, managing kick-off and review meetings, addressing scope issues, and implementing feedback.

• Documentation & Knowledge Management:

  • Generate and maintain study-related reports, ensuring accurate documentation of build specifications and progress.

  • Create and manage standard libraries within the eSource design tool to promote reusability and efficiency.

  • Assist in maintaining reference documentation and support peer training initiatives within the Study Build team.

  • Support the scoping and documentation of Change Control requests.

📝 Enhancement Note: The responsibilities highlight a critical operational function within a clinical technology company. The emphasis on translating protocols, defining system requirements, managing UAT, and cross-functional communication is core to ensuring successful trial technology deployment. This role requires a strong blend of technical understanding, project management acumen, and client-facing skills.

🎓 Skills & Qualifications

Education:

• Bachelor’s degree in clinical trial design, life sciences, healthcare informatics, or a related field.

Experience:

• 2-5 years of experience in clinical research, with a focus on study build, protocol design, or clinical technology implementation.

• Proven experience in translating complex clinical trial protocols into technical specifications or system configurations.

Required Skills:

• Clinical Research Expertise: Proficient knowledge of clinical research processes, regulations (e.g., FDA 21 CFR Part 11, ICH-GCP), and protocol design principles.

• System Requirements Definition: Ability to meticulously define system requirements, including application configuration, form content, metadata, and functionality based on protocol specifications.

• eCOA/DDC Platform Knowledge: Familiarity with electronic Data Capture (EDC), eCOA, or DDC systems and their build configurations.

• Cross-functional Collaboration: Demonstrated ability to work effectively with diverse internal teams (e.g., Project Management, Data Management, Programming) and external clients.

• Communication & Interpersonal Skills: Excellent written, verbal, and interpersonal communication skills, with the ability to clearly articulate technical concepts to both technical and non-technical audiences.

• Organizational & Detail-Oriented: Strong organizational skills, exceptional attention to detail, and the ability to effectively multi-task and manage competing priorities in a fast-paced environment.

• Problem-Solving: Ability to identify needs and issues, track progress, and follow through on actions to ensure customer satisfaction and project success.

• MS Office Proficiency: Competent in using MS Office Suite, particularly Word and Excel, for documentation, data analysis, and reporting.

Preferred Skills:

• Experience with specific eCOA/DDC platforms (e.g., Clinical Ink's eSource, Medidata Rave, Oracle Clinical).

• Familiarity with data export requirements and mapping for clinical trial data.

• Experience leading client-facing meetings and managing client expectations.

• Knowledge of change control processes in clinical trial management.

• Experience in creating and maintaining standard libraries or templates for system builds.

📝 Enhancement Note: The requirements emphasize a blend of clinical research domain knowledge and technical aptitude for system configuration. The "I" in the title suggests that while some experience is needed, extensive hands-on experience with all aspects of a complex eCOA build might be supported by management, making it an ideal role for someone looking to grow their expertise in clinical technology operations.

📊 Process & Systems Portfolio Requirements

Portfolio Essentials:

• Case Studies of System Builds: Examples demonstrating your ability to translate a clinical protocol into a configured eCOA or DDC system. Showcase the complexity of the protocol and how you addressed specific data collection or functional requirements.

• Requirement Definition Examples: Documentation samples of system requirements you have defined, highlighting clarity, completeness, and alignment with protocol objectives.

• UAT Planning & Execution: Evidence of your involvement in UAT, such as UAT test scripts, issue logs, or summaries of UAT feedback and resolutions.

• Process Flow Diagrams: Visual representations of a typical study build process or a specific workflow you designed or optimized, demonstrating your understanding of sequential steps and dependencies.

Process Documentation:

• Workflow Design: Showcase your ability to design and document workflows for system configuration, UAT, and change control processes, emphasizing efficiency and clarity.

• Implementation & Automation: If applicable, provide examples of how you contributed to the implementation of new system features or automated repetitive tasks within the build process.

• Measurement & Analysis: Demonstrate how you tracked progress, identified bottlenecks, or used data to inform decisions during the study build process, even if informal.

📝 Enhancement Note: For a role like this, a portfolio is crucial for demonstrating practical application of skills. Candidates should focus on tangible examples of their work in translating clinical needs into technical solutions, managing quality through testing, and documenting processes. Quantifiable results, even if related to efficiency gains or successful UAT completion, will strengthen their application.

💵 Compensation & Benefits

Salary Range:

Benefits:

• Comprehensive health, dental, and vision insurance plans.

• Retirement savings plan with company match (e.g., 401(k)).

• Generous paid time off (PTO), including vacation, sick leave, and holidays.

• Professional development opportunities, including training, certifications, and conference attendance.

• Remote work stipend or home office setup allowance.

• Potential for performance-based bonuses.

Working Hours:

• Standard full-time work schedule, typically 40 hours per week.

• Flexibility in daily start and end times is generally offered, provided core business hours and client meeting needs are met.

• Occasional need to adjust hours to accommodate client time zones or critical project deadlines.

📝 Enhancement Note: Salary estimation is based on typical mid-level project management and technical roles in the clinical technology sector in the US, factoring in remote work. Benefits are standard offerings for full-time employees in this industry. The flexibility in working hours is common for remote roles but emphasizes the need to align with team and client needs.

🎯 Team & Company Context

🏢 Company Culture

Industry: Life Sciences / Clinical Research Technology. Clinical Ink specializes in bringing data, technology, and patient science together to advance clinical discovery through innovative solutions like Direct Data Capture (DDC), eCOA, eConsent, telehealth, and digital biomarkers.

Company Size: While the provided data does not specify company size, Clinical Ink is a well-established player in the clinical trial technology space, suggesting a medium to large-sized organization with dedicated teams for study build, project management, data management, and clinical programming.

Founded: Clinical Ink was founded to revolutionize clinical development, indicating a company culture that likely values innovation, efficiency, and a forward-thinking approach to healthcare technology.

Team Structure:

• Study Build Team: This team is central to the role, responsible for configuring the DDC and eCOA platforms based on study protocols. It likely includes Project Design Managers, Study Build

Specialists, and potentially junior configurators.

• Cross-functional Collaboration: The Project Design Manager will interact extensively with:

  • Study Operations Leads: To understand resource needs and overall study execution context.
  • Project Management: To align on timelines, scope, and client communication.
  • Project Data Management: To ensure data integrity, mapping, and export requirements are met.
  • Clinical Programming: To coordinate system logic, data handling, and integration.

• Reporting Structure: The Project Design Manager I will likely report to a Manager within the Study Build team, who provides guidance and oversight.

Methodology:

• Data-Driven Design: Emphasis on using protocol data and client requirements to precisely configure systems.

• Agile/Iterative Build: While not explicitly stated, the process of reviewing protocols, defining requirements, building, testing, and iterating suggests an agile or iterative approach to system development.

• Standardization & Reusability: The creation of standard libraries indicates a focus on efficiency through reusable components and best practices.

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

📝 Enhancement Note: Understanding Clinical Ink's mission and industry position is key. The company focuses on data precision and a new generation of clinical trials, implying a culture that values accuracy, technological advancement, and a patient-centric approach to data collection. The "Study Build" team is a core operational unit, and collaboration is paramount.

📈 Career & Growth Analysis

Operations Career Level: This role, "Project Design Manager I," is positioned as an entry to mid-level position within the clinical technology operations domain. It requires foundational knowledge of clinical research and the ability to learn complex systems, indicating a focus on developing specialized skills in eCOA/DDC configuration and study design translation. It serves as a crucial stepping stone for professionals aiming for senior roles in clinical operations technology.

Reporting Structure: The individual will report to a Manager within the Study Build team. This manager will provide guidance, mentorship, and oversight, particularly for the "I" level responsibilities where support may be needed for more complex tasks or client interactions.

Operations Impact: The Project Design Manager I plays a direct role in ensuring the technical foundation of clinical trials is robust and accurate. Their work directly impacts:

• Data Precision: Ensuring data collected is accurate, complete, and compliant.

• Trial Efficiency: Streamlining data collection processes through effective system design.

• Client Satisfaction: Meeting client needs and delivering high-quality, functional study builds.

• Regulatory Compliance: Adhering to guidelines for data collection and system validation.

Growth Opportunities:

• Specialization in Clinical Technology: Deepen expertise in eCOA, DDC, digital biomarkers, and other clinical trial technologies.

• Advancement to Senior Roles: Progress to Project Design Manager II, Senior Project Design Manager, or Lead Study Build Specialist, taking on more complex projects and greater client responsibility.

• Project Management Track: Transition into Clinical Project Management roles, leveraging the understanding of study build and operational execution.

• Technical Expertise: Develop advanced skills in specific eCOA/DDC platforms, potentially becoming a subject matter expert.

• Leadership Development: Gain experience leading client meetings and internal project discussions, preparing for future team leadership opportunities.

📝 Enhancement Note: This role offers a clear path for growth within the specialized field of clinical trial technology operations. The "I" designation implies a learning and development focus, with opportunities to build expertise and take on more responsibility as proficiency increases.

🌐 Work Environment

Office Type: Fully Remote. This role operates entirely outside of a traditional office setting, requiring a dedicated home office space conducive to focused work and professional virtual interactions.

Office Location(s): Remote within the United States. This offers flexibility in geographic location for the employee, though company headquarters are in Philadelphia, PA, Winston Salem, NC, and Iowa City, IA.

Workspace Context:

• Independent Work: The role requires a high degree of self-direction and the ability to work independently following initial training.

• Virtual Collaboration: Expect frequent use of video conferencing, instant messaging, and collaborative online tools for team meetings and client interactions.

• Technology Infrastructure: Reliable high-speed internet access and a suitable home office setup are essential to effectively perform duties.

• Focus on Process & Data: The environment supports deep concentration on protocol details, system configuration, and data integrity.

Work Schedule:

• The standard 40-hour work week provides a structured framework, but the remote nature allows for some flexibility in daily scheduling.

• It is crucial to be available for scheduled meetings (internal and client-facing) and to respond to urgent requests promptly, which may occasionally require adjusting hours.

• The company's presence in multiple US time zones suggests a need for adaptability in scheduling collaborative sessions.

📝 Enhancement Note: The fully remote nature of this role is a significant factor. It demands strong self-management skills and comfort with virtual communication tools. While flexible, the need to align with team and client schedules is a critical operational consideration.

📄 Application & Portfolio Review Process

Interview Process:

• Initial Screening: A recruiter or HR representative will review applications, focusing on relevant experience in clinical research and technical aptitude.

• Hiring Manager Interview: An in-depth discussion with the Hiring Manager to assess your understanding of clinical protocols, system design principles, and experience with study builds or related technologies. Expect behavioral questions related to problem-solving, collaboration, and attention to detail.

• Technical/Skills Assessment: This may involve a practical exercise or case study to evaluate your ability to translate a simplified protocol into system requirements or identify key considerations for an eCOA build.

• Team/Cross-functional Interview: You may meet with potential colleagues from Study Operations, Data Management, or Programming to assess cultural fit and collaboration style.

• Final Interview: Potentially with a senior leader to discuss career aspirations and overall fit within the organization.

Portfolio Review Tips:

• Structure Your Case Studies: For each case study, clearly outline:

  • The original protocol's objective.
  • Your role and specific contributions.
  • The system requirements you defined or influenced.
  • Any challenges encountered and how you addressed them.
  • The outcome or impact (e.g., successful UAT, efficient build).

• Highlight Process Mapping: If you have process flow diagrams, ensure they are clear, logically sequenced, and showcase your understanding of workflow optimization.

• Quantify When Possible: Even for a "Project Design Manager I," try to quantify your contributions. For example, "Contributed to the build of X studies, impacting Y patient data points," or "Identified Z potential scope issues during UAT planning, saving an estimated X hours of rework."

• Focus on Translation: Emphasize your ability to bridge the gap between clinical language (protocols) and technical language (system configurations).

Challenge Preparation:

• Protocol Analysis: Be prepared to analyze a short, simplified clinical protocol excerpt and identify key data collection points, potential system configurations, and any ambiguities or areas needing clarification.

• Requirement Drafting: You might be asked to draft a few specific system requirements based on a given protocol snippet.

• UAT Scenario: Discuss how you would approach UAT for a specific feature or form, including what you would test and what potential issues you might look for.

• Collaboration Scenarios: Prepare to answer questions about how you would collaborate with different teams (e.g., Data Management, Clinical Programming) to ensure a successful study build.

📝 Enhancement Note: The interview process for this role will likely assess both technical understanding of clinical trial technology and practical application through case studies or assessments. A strong portfolio showcasing the ability to translate clinical needs into technical specifications is paramount.

🛠 Tools & Technology Stack

Primary Tools:

• eSource Design Tool: Clinical Ink's proprietary tool for configuring DDC and eCOA systems. Proficiency or the ability to quickly learn such tools is essential.

• Project Management Software: Tools like Asana, Jira, Microsoft Project, or similar for tracking tasks, timelines, and project progress.

• Collaboration Platforms: Microsoft Teams, Slack, Zoom, or similar for internal and client communication, meetings, and file sharing.

Analytics & Reporting:

• MS Excel: For data manipulation, basic analysis, creating reports, and managing UAT data.

• Reporting Tools: Potentially internal reporting dashboards or tools used by the company for study build progress tracking.

CRM & Automation:

• CRM System (e.g., Salesforce): May be used internally for client management and tracking project lifecycles, though not a primary tool for this role's core function.

• Basic Workflow Automation: Understanding of how forms and logic within eCOA systems automate data collection and guide users.

📝 Enhancement Note: While specific proprietary tools are mentioned, the emphasis is on the ability to learn and adapt to specialized software used in clinical trial technology. Proficiency in standard office productivity and collaboration tools is a given.

👥 Team Culture & Values

Operations Values:

• Precision & Accuracy: A core value in clinical research, ensuring data collected is exact and reliable. This translates to meticulous attention to detail in system configuration.

• Collaboration & Teamwork: Essential for bridging gaps between clinical, technical, and project management functions. The company likely fosters an environment where communication and mutual support are key.

• Innovation & Efficiency: Clinical Ink's mission implies a drive to find new and better ways to conduct clinical trials, valuing solutions that improve speed and effectiveness.

• Patient Centricity: Ultimately, the technology serves the patient experience in trials. This value likely influences design decisions to ensure ease of use and minimal burden.

• Accountability & Ownership: Taking responsibility for study builds, from design to UAT, and seeing tasks through to completion.

Collaboration Style:

• Cross-functional Integration: Expect a highly collaborative environment where individuals from different departments regularly interact to achieve common goals.

• Open Communication: Encouragement of open dialogue to resolve issues, share insights, and ensure alignment across teams.

• Feedback Loops: A culture that values constructive feedback, both in giving and receiving, to continuously improve processes and system designs.

• Shared Ownership of Success: The success of a clinical trial build is a shared responsibility, fostering a sense of collective achievement.

📝 Enhancement Note: The company's focus on "data, technology, and patient science" suggests a culture that is analytically driven, technologically progressive, and committed to improving patient outcomes. Collaboration is not just encouraged but is a fundamental operational necessity.

⚡ Challenges & Growth Opportunities

Challenges:

• Complexity of Protocols: Translating highly complex or ambiguous clinical protocols into clear, functional system requirements can be demanding.

• Managing Client Expectations: Balancing client requests with technical feasibility, regulatory requirements, and project timelines requires strong negotiation and communication skills.

• Rapid Technological Evolution: Staying abreast of advancements in clinical trial technology and adapting to new platform features or industry standards.

• Balancing Speed and Quality: The pressure to deliver builds quickly while maintaining impeccable accuracy and adherence to regulatory standards.

• Remote Work Dynamics: Maintaining strong team cohesion and effective communication in a fully remote setting.

Learning & Development Opportunities:

• Specialized Training: In-depth training on Clinical Ink's eSource design tool and other proprietary technologies.

• Clinical Trial Operations Expertise: Deepen understanding of clinical trial phases, regulatory landscapes, and site operations.

• System Design Best Practices: Continuous learning in designing user-friendly and efficient eCOA/DDC systems.

• Client Management Skills: Developing advanced skills in client communication, expectation management, and relationship building.

• Industry Conferences & Webinars: Opportunities to attend industry events (virtual or in-person) to stay current with trends.

📝 Enhancement Note: This role presents opportunities to become a subject matter expert in a highly specialized and in-demand area of clinical trial technology. Overcoming the challenges will directly contribute to professional growth and career advancement.

💡 Interview Preparation

Strategy Questions:

• Protocol Interpretation: "Given this sample protocol section, what are the key data points you would ensure are captured, and what specific configurations might you consider in an eCOA system?"

  • Prep: Review common protocol sections (e.g., visit schedules, assessments, adverse events). Practice identifying critical data elements and thinking about how they translate to form fields and logic.

• System Requirements: "Describe a situation where you had to define system requirements. What was your process, and how did you ensure accuracy and completeness?"

  • Prep: Prepare a STAR (Situation, Task, Action, Result) story focusing on a time you translated a need into a technical specification. Highlight your methodical approach.

• UAT Planning: "How would you approach User Acceptance Testing for a new eCOA form? What are the critical elements to test?"

  • Prep: Think about testing data input, validation rules, navigation, data display, and potential edge cases. Consider the client perspective.

• Collaboration: "How would you collaborate with a Project Data Manager to ensure that the data collected in the eCOA system can be accurately exported and mapped for analysis?"

  • Prep: Focus on communication strategies, understanding data mapping needs, and proactively addressing potential export issues.

Company & Culture Questions:

• "Why are you interested in Clinical Ink and this specific role?"

  • Prep: Research Clinical Ink's mission, technologies, and recent news. Connect your skills and career goals to their work in advancing clinical discovery.

• "How do you handle working independently in a remote environment?"

  • Prep: Provide examples of your self-motivation, time management, and proactive communication in remote settings.

• "Describe a time you had to manage conflicting priorities or tight deadlines. How did you handle it?"

  • Prep: Prepare a STAR story demonstrating your organizational skills and ability to prioritize effectively under pressure.

Portfolio Presentation Strategy:

• Concise Storytelling: For each portfolio item, tell a brief, impactful story that highlights the problem, your solution, and the positive outcome.

• Focus on the "Why": Explain why certain design choices were made, linking them back to the protocol requirements or user needs.

• Demonstrate Your Process: Walk through your thought process for translating a protocol into requirements, showcasing your analytical and problem-solving skills.

• Be Ready for Technical Deep Dives: While the role is "I," be prepared to discuss the technical aspects of your examples at a reasonable level.

📝 Enhancement Note: Interview preparation should focus on demonstrating practical application of skills through structured examples and a clear understanding of the clinical trial technology landscape. Highlighting your ability to learn and adapt will be key for this "I" level role.

📌 Application Steps

To apply for this operations position:

• Submit your application through the provided application link on recruitingbypaycor.com.

• Tailor Your Resume: Ensure your resume clearly highlights experience in clinical research, protocol review, system configuration (if any), user acceptance testing, and cross-functional collaboration. Use keywords from the job description such as "eCOA," "DDC," "protocol translation," and "system requirements."

• Prepare Your Portfolio: Curate 2-3 strong examples that showcase your ability to translate clinical requirements into technical specifications or system designs. Focus on clarity, process, and tangible outcomes. If you lack direct eCOA build experience, highlight transferable skills from related areas like clinical data management, study design, or regulatory documentation.

• Practice Interview Responses: Rehearse answers to common interview questions, particularly those related to problem-solving, collaboration, and your understanding of clinical trial processes and technology. Prepare to walk through your portfolio examples.

• Research ClinClinicaLink: Familiarize yourself with Clinical Ink's mission, services, and recent developments. Understand their position in the life sciences and clinical trial technology market.

⚠️ 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.