Clinical Study Design Manager

📍 Job Overview

Job Title: Clinical Study Design Manager

Company: Science 37

Location: Morrisville, North Carolina, United States

Job Type: Full-Time

Category: Clinical Operations / Life Sciences Operations

Date Posted: August 11, 2026

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

Remote Status: On-site

🚀 Role Summary

• Responsible for defining and specifying eSource platform design requirements for clinical studies, ensuring alignment with protocol specifications and client needs.

• Manages the end-to-end lifecycle of the eSource platform, from initial design and specification through to final build and implementation.

• Oversees offshore build teams to ensure timely delivery of high-quality platform builds that meet all technical and design requirements.

• Serves as a Subject Matter Expert (SME) for system capabilities, data capture configuration, and the validation of the eSource Platform.

• Drives operational efficiency by implementing standard templates and contributing to streamlined build and quality control processes.

📝 Enhancement Note: This role is critical for bridging the gap between clinical trial protocols and the technical build of the eSource platform, requiring a strong understanding of both clinical research processes and system configuration. The emphasis on managing offshore teams highlights a need for robust project management and cross-cultural communication skills.

📈 Primary Responsibilities

• Define and document eSource design specifications, collaborating with internal teams (e.g., Clinical Operations, Data Management) and external clients to capture all data collection requirements accurately.

• Oversee the build process of the eSource platform by offshore teams, ensuring adherence to project timelines, technical specifications, and quality standards.

• Act as the primary point of contact and SME for system capabilities, data capture configurations, and the validation of the eSource Platform throughout the study lifecycle.

• Implement and promote the use of standard templates and libraries to enhance building efficiency and contribute to the development of streamlined build and Quality Control (QC) processes.

• Lead and participate in highly cross-functional project teams, interacting with clients, Site Operations Managers, and other internal stakeholders to document and refine data collection requirements.

• Develop and maintain project timelines for design activities, closely monitoring progress and ensuring accountability for key performance indicators (KPIs), quality metrics, and performance benchmarks.

• Manage the build, testing, and implementation of direct data capture services, ensuring seamless system integration and overseeing user acceptance testing (UAT) to meet all quality deliverables.

• Contribute to the review and revision of Standard Operating Procedures (SOPs) and work instructions to maintain and improve operational documentation.

• Train and mentor Platform Build Managers and support specialists to cultivate a culture of operational excellence, speed, and continuous improvement.

• Manage user access for all Science 37 eSource platforms, ensuring data security and compliance with access control policies.

• Partner with Clinical Operations and Data Management to provide early strategic input on protocol design and effectively execute post-production changes to the eSource platform.

• Build and maintain strong, positive working relationships with clients, sponsors, and vendors to facilitate successful project execution and client satisfaction.

📝 Enhancement Note: The responsibilities emphasize a blend of technical system design, project management, cross-functional collaboration, and team leadership, particularly in managing offshore resources. The role requires a proactive approach to problem-solving and a commitment to driving efficiency within the clinical research technology landscape.

🎓 Skills & Qualifications

Education:

• Bachelor’s degree or equivalent experience in a health science field (e.g., Biology, Nursing, Pharmacy, Public Health). Experience:

• Minimum of 3 years of experience in clinical research or the life sciences industry.

• At least 3 years of experience specifically in the design of Case Report Forms (CRF), electronic Patient-Reported Outcomes (ePRO), or other clinical trial database capture software.

• Minimum of 2 years of direct experience with the CRIO platform is a mandatory requirement.

• Experience working in a fast-paced, growth-oriented company environment, demonstrating flexibility and adaptability to evolving requirements. Required Skills:

• Deep understanding of the clinical research development process and relevant regulatory guidelines (e.g., GCP, FDA).

• Proficiency in defining and documenting data capture requirements for clinical trials.

• Expertise in eSource platform design and configuration, including direct data capture methodologies.

• Proven ability to manage project timelines, monitor progress, and ensure delivery against quality metrics and KPIs.

• Strong analytical and problem-solving skills, with the ability to identify issues, propose solutions, and drive them to completion.

• Excellent written and verbal communication skills, capable of articulating complex technical and clinical concepts to diverse audiences.

• Demonstrated ability to build and maintain positive relationships with clients, sponsors, vendors, and internal teams.

• High level of attention to detail, outstanding organizational skills, and a blend of analytical thinking, strategic planning, and implementation capabilities.

• Working knowledge of Microsoft Office suite and Google applications.

• Familiarity with electronic clinical technologies and their application in research. Preferred Skills:

• Experience in managing and guiding cross-functional teams, including offshore resources.

• Knowledge of drug development processes and specific regulatory guidelines.

• Experience in building and leveraging organizational teams, fostering collaboration and accountability.

• Situational responsiveness and effective decision-making skills.

• Action-oriented and goal-oriented mindset with an innovative approach to problem-solving.

• Demonstrates teamwork, cooperation, self-control, and flexibility to achieve objectives.

📝 Enhancement Note: The requirement for CRIO platform experience is highly specific and critical. Candidates should highlight their experience with this system, along with their ability to translate protocol requirements into configurable platform specifications. The blend of technical, project management, and interpersonal skills is essential for success in this role.

📊 Process & Systems Portfolio Requirements

Portfolio Essentials:

• eSource Design Case Studies: Showcase examples of eSource platform designs you have specified for clinical studies, detailing the protocol requirements, data capture logic, and any innovative solutions implemented.

• CRF/ePRO Design Examples: Include samples or detailed descriptions of CRFs or ePRO modules you have designed, demonstrating an understanding of data standards, query reduction, and user experience.

• Process Optimization Initiatives: Provide documentation or case studies illustrating how you have improved build efficiency, reduced QC time, or streamlined data capture processes. Quantify the impact where possible.

• System Integration Experience: Detail any experience you have in ensuring seamless integration between the eSource platform and other clinical trial systems (e.g., EDC, Data Management Systems), highlighting challenges and resolutions.

• Validation Documentation: Present examples of documentation related to system validation, user acceptance testing (UAT), or quality control procedures you have overseen or contributed to.

Process Documentation:

• Workflow Design & Optimization: Demonstrate your ability to map out and document complex data capture workflows, identifying bottlenecks and proposing optimized solutions for improved efficiency and data quality.

• Implementation & Automation Methods: Showcase your experience in overseeing the implementation of eSource platform builds, including methodologies for managing offshore teams and ensuring adherence to build standards.

• Measurement & Performance Analysis: Provide examples of how you have defined and tracked key performance indicators (KPIs) and quality metrics for platform builds, and how you use this data to drive continuous improvement.

📝 Enhancement Note: A strong portfolio for this role should not only showcase design capabilities but also demonstrate a deep understanding of the end-to-end build and implementation process, with a clear focus on efficiency, quality, and managing remote/offshore teams. Candidates should be prepared to walk through their portfolio with specific examples of how they translated complex requirements into functional systems.

💵 Compensation & Benefits

Salary Range:

Based on industry benchmarks for a Clinical Study Design Manager with 2-5 years of experience in the pharmaceutical/biotech sector, located in the Research Triangle Park (RTP) area of North Carolina, the estimated annual salary range is $90,000 - $120,000. This estimate accounts for the specific technical expertise required (e.g., CRIO platform, eSource design), the mid-senior level of the role, and the cost of living in the Morrisville, NC region.

Benefits:

Science 37 typically offers a comprehensive benefits package designed to support employee well-being and professional development. While specific details may vary, common benefits in the life sciences industry include:

• Health Insurance: Medical, dental, and vision insurance plans.

• Retirement Savings: 401(k) plan with potential company matching.

• Paid Time Off (PTO): Generous vacation, sick leave, and paid holidays.

• Life and Disability Insurance: Company-paid or optional life and long-term/short-term disability insurance.

• Professional Development: Opportunities for training, conferences, and continuing education relevant to clinical research technology and operations.

• Stock Options/Equity: Potential for equity participation in a growth-stage company.

• Wellness Programs: Initiatives focused on employee health and well-being.

Working Hours:

The standard working hours for this position are typically 40 hours per week, aligning with full-time employment. Given the role's responsibilities, including oversight of offshore teams, some flexibility may be required to accommodate different time zones and urgent project needs.

📝 Enhancement Note: The salary range is an estimate based on publicly available data for similar roles in the specified location and industry. Actual compensation will be determined by the company based on the candidate's experience, qualifications, and internal compensation structures. Candidates are encouraged to confirm the full benefits package during the interview process.

🎯 Team & Company Context

🏢 Company Culture

Industry: Biotechnology / Pharmaceutical Services / Clinical Research Technology (SaaS)

Company Size: Science 37 operates as a growth-stage company, likely falling within the 201-500 employee range, indicating a dynamic and evolving work environment. This size often means opportunities for significant impact and a less bureaucratic structure compared to larger, established organizations.

Founded: Science 37 was founded in 2014, positioning it as a relatively modern company that has established itself in the decentralized clinical trials space. Its founding vision likely centers on leveraging technology to revolutionize how clinical research is conducted.

Team Structure:

• Operations Focus: The operations team at Science 37 is likely structured to support the core business of decentralized clinical trials, with a strong emphasis on technology, platform development, and site/patient engagement.

• Reporting: The Clinical Study Design Manager will likely report to a Director or Senior Manager within the Clinical Operations or Technology Solutions department. This structure suggests a reporting hierarchy that values expertise and project management capabilities.

• Cross-functional Collaboration: Collaboration is a cornerstone of Science 37's model. The role will involve extensive interaction with client-facing teams (Client Services, Project Management), technical teams (Engineering, Product Development), data management, clinical operations, and potentially regulatory affairs.

Methodology:

• Data-Driven Design: The company's approach to eSource platform design will be heavily data-driven, focusing on optimizing data capture for accuracy, efficiency, and compliance, directly impacting trial outcomes.

• Agile & Iterative Development: Given the fast-paced nature of technology and clinical research, the team likely employs agile or iterative methodologies for platform development and refinement.

• Process Standardization & Innovation: There's a balance between standardizing processes (e.g., using templates, SOPs) to ensure consistency and quality, and fostering innovation to adapt to new trial designs and technologies.

Company Website: https://www.science37.com/

📝 Enhancement Note: Science 37's mission to accelerate clinical research through decentralized models implies a culture that values innovation, technological adoption, and a patient-centric approach. The company's growth stage suggests opportunities for individuals to contribute significantly to shaping operational processes and platform capabilities.

📈 Career & Growth Analysis

Operations Career Level: This role is positioned as a mid-to-senior level individual contributor, requiring specialized knowledge and experience. It's a key operational role that directly influences the successful execution of clinical trials by ensuring the integrity and efficiency of the data capture system.

Reporting Structure: The Clinical Study Design Manager will likely report to a Director or Senior Manager of Clinical Operations or Technology Solutions. This reporting line offers exposure to strategic decision-making and senior leadership within the operations and technology functions. The manager may also have direct reports, such as Platform Build Managers or Support Specialists, indicating a potential for people management.

Operations Impact: The operations managed by this role have a direct and significant impact on:

• Trial Efficiency: Streamlined eSource design leads to faster data entry, reduced query times, and quicker database lock.

• Data Quality: Robust design specifications ensure accurate and complete data collection, crucial for regulatory submissions and trial integrity.

• Client Satisfaction: Successful platform implementation and performance directly contribute to client retention and satisfaction with Science 37's services.

• Regulatory Compliance: Adherence to protocols and regulatory guidelines in platform design is paramount.

Growth Opportunities:

• Senior/Lead Study Design Manager: Progression to a lead role, overseeing more complex studies, mentoring junior staff, and contributing to strategic platform development.

• Manager/Director of Clinical Operations Technology: Moving into a management position overseeing broader technology solutions, platform strategy, and team development.

• Product Management: Transitioning into product management roles focused on the eSource platform or other clinical technology offerings.

• Specialization: Deepening expertise in specific therapeutic areas or advanced data capture technologies.

• Cross-functional Moves: Opportunities to move into roles within Data Management, Project Management, or Client Services, leveraging a strong understanding of the operational technology landscape.

📝 Enhancement Note: The growth path for a Clinical Study Design Manager is well-defined within the operations and technology arms of a clinical research organization. The role provides a solid foundation for leadership and specialized technical careers, particularly in the rapidly evolving field of decentralized clinical trials technology.

🌐 Work Environment

Office Type: The position is based in Morrisville, NC, implying a physical office environment. Science 37, as a company that enables remote participation in trials, likely fosters a modern, collaborative office space that supports innovation and team interaction.

Office Location(s): Morrisville, North Carolina, within the Research Triangle Park (RTP) area, a hub for life sciences and technology companies. This location offers access to a strong talent pool and a thriving industry ecosystem.

Workspace Context:

• Collaborative Hub: The office is expected to be a space for team meetings, brainstorming sessions, and cross-functional collaboration, particularly for tasks that benefit from in-person interaction or managing offshore teams.

• Technology-Enabled: Expect access to the necessary tools and technologies to perform the job, including robust IT infrastructure, communication platforms, and access to the Science 37 eSource platform and associated software.

• Team Interaction: Opportunities to directly engage with colleagues from various departments, fostering a sense of shared purpose and facilitating the smooth execution of study designs.

Work Schedule: While the standard is 40 hours per week, the nature of managing international teams and critical study timelines may necessitate some flexibility. This could involve occasional early morning or late afternoon calls to align with offshore team schedules. The emphasis on efficiency suggests a results-oriented work environment.

📝 Enhancement Note: The on-site requirement in Morrisville, NC, suggests that the company values in-person collaboration for critical design and team management functions, even while operating in a space that enables remote work for research participants. The RTP location is a significant draw for talent in the life sciences.

📄 Application & Portfolio Review Process

Interview Process:

The interview process for a Clinical Study Design Manager at Science 37 is likely multi-stage, designed to assess technical expertise, project management skills, and cultural fit:

1. Initial Screening: A brief call with an HR representative or recruiter to assess basic qualifications, salary expectations, and interest in the role.

2. Hiring Manager Interview: A more in-depth discussion with the direct hiring manager focusing on your experience with clinical research, eSource design, CRIO platform, and team management. Expect questions about your approach to problem-solving and managing offshore teams.

3. Technical/Panel Interview: This may involve meeting with members of the operations and/or technology team. You could be asked to walk through a portfolio case study or discuss specific technical challenges related to eSource design and implementation. Be prepared for scenario-based questions.

4. Cross-functional Interview(s): Interviews with stakeholders from related departments (e.g., Clinical Operations, Data Management) to evaluate collaboration skills and understanding of their respective needs.

5. Final Interview/Offer: Potentially a final conversation with senior leadership before an offer is extended.

Portfolio Review Tips:

• Structure Your Case Studies: For each eSource design project, clearly outline the challenge (protocol requirements), your solution (design specifications, logic), the implementation process (especially if involving offshore teams), and the outcome (impact on efficiency, data quality, client satisfaction).

• Quantify Your Impact: Use metrics whenever possible. For example, "Reduced data query rate by X%," "Decreased build time by Y days," or "Successfully implemented Z study protocols within budget and on time."

• Highlight CRIO Expertise: Explicitly showcase your experience with the CRIO platform in your portfolio. Detail specific configurations, modules, or features you utilized and how they contributed to study success.

• Demonstrate Process Improvement: Include examples where you identified inefficiencies in the design or build process and implemented solutions that led to measurable improvements.

• Tailor to the Role: Emphasize aspects of your portfolio that directly align with the job description, such as managing offshore teams, ensuring protocol alignment, and driving quality control.

Challenge Preparation:

• eSource Design Scenario: Be prepared for a hypothetical scenario where you are given a simplified clinical trial protocol and asked to outline the key eSource design specifications, potential challenges, and how you would manage the build process.

• Process Optimization Question: You might be asked to describe how you would improve a specific aspect of the eSource build process or data capture workflow.

• Team Management: Prepare to discuss how you would manage and motivate an offshore build team, ensuring clear communication and accountability.

• Protocol Interpretation: Practice translating complex protocol language into actionable system requirements.

📝 Enhancement Note: The portfolio review is a critical component for this role. Candidates should prepare a digital portfolio that is easily navigable and clearly demonstrates their expertise in eSource design, CRIO platform usage, and project management, especially concerning offshore team coordination.

🛠 Tools & Technology Stack

Primary Tools:

• CRIO Platform: Essential and mandatory requirement. Deep expertise in its configuration, data capture capabilities, and validation processes is expected.

• eSource Platforms: Experience with other direct data capture or eSource solutions beyond CRIO is beneficial for understanding broader industry standards.

• Clinical Trial Management Systems (CTMS): Familiarity with CTMS for project tracking and oversight.

Analytics & Reporting:

• Microsoft Office Suite: Advanced proficiency in Excel for data analysis, reporting, and creating project documentation. PowerPoint for presentations and stakeholder communications.

• Google Applications: Familiarity with Google Workspace tools for collaboration and productivity.

• Business Intelligence (BI) Tools (e.g., Tableau, Power BI): While not explicitly mentioned, experience with BI tools for data visualization and reporting on build performance and quality metrics would be advantageous.

CRM & Automation:

• CRM Systems (e.g., Salesforce): Understanding of how eSource platforms integrate with CRM or other client management systems.

• Project Management Software: Tools like Jira, Asana, or similar for task management, workflow tracking, and collaboration, especially when managing offshore teams.

• Communication & Collaboration Platforms: Slack, Microsoft Teams, Zoom, etc., for daily team interaction and client communication.

📝 Enhancement Note: Proficiency with the CRIO platform is non-negotiable. Candidates should be ready to demonstrate their practical experience with this system and how they leverage it for efficient and high-quality eSource design and implementation.

👥 Team Culture & Values

Operations Values:

• Patient-Centricity: A core value at Science 37, ensuring that all operational decisions and technological solutions ultimately serve to improve patient access and outcomes in clinical research.

• Innovation & Agility: Embracing new technologies and methodologies to push the boundaries of decentralized clinical trials and adapt quickly to market changes.

• Quality & Precision: A commitment to maintaining the highest standards of data integrity, regulatory compliance, and operational excellence in all aspects of study design and execution.

• Collaboration & Transparency: Fostering an environment where open communication, teamwork, and knowledge sharing are encouraged across all departments and with clients.

• Efficiency & Speed: Driving operational processes to be as streamlined and efficient as possible without compromising quality, enabling faster trial completion.

Collaboration Style:

• Cross-Functional Integration: Expect a highly collaborative environment where working closely with Client Services, Clinical Operations, Data Management, and Engineering teams is the norm.

• Remote/Global Teamwork: A proven ability to collaborate effectively with remote teams and international partners, utilizing digital tools to bridge geographical distances.

• Feedback-Driven Improvement: A culture that values constructive feedback for continuous improvement of processes, platforms, and team dynamics.

• Problem-Solving Focus: A collective approach to tackling challenges, where teams work together to find innovative solutions.

📝 Enhancement Note: The company's culture likely reflects its mission: to revolutionize clinical research through technology. Candidates should demonstrate an alignment with these values, particularly an interest in decentralized trials, a proactive approach to innovation, and strong collaborative skills.

⚡ Challenges & Growth Opportunities

Challenges:

• Managing Offshore Teams: Effectively communicating requirements, ensuring quality control, and maintaining accountability with teams located in different geographical regions and time zones.

• Balancing Protocol Complexity with Platform Capabilities: Translating intricate and sometimes novel clinical trial protocols into functional and efficient eSource platform configurations.

• Rapid Technological Evolution: Keeping pace with advancements in clinical technology and adapting platform designs and processes accordingly.

• Client Expectations Management: Aligning client needs and expectations with the capabilities and timelines of platform development and implementation.

• Data Integrity & Regulatory Compliance: Ensuring that all design decisions uphold the highest standards of data integrity and meet stringent regulatory requirements.

Learning & Development Opportunities:

• Deep Dive into CRIO and eSource Technology: Opportunities to become a true expert in Science 37's core technology stack and contribute to its future development.

• Decentralized Clinical Trials (DCT) Specialization: Gaining in-depth knowledge and experience in the rapidly growing field of DCTs and their operational intricacies.

• Leadership Development: Potential pathways to manage teams, lead projects, and develop strategic operational plans.

• Industry Exposure: Learning from diverse clients and therapeutic areas, broadening understanding of the clinical research landscape.

• Process Improvement Methodologies: Formal or informal training in lean principles or other process optimization techniques to enhance operational efficiency.

📝 Enhancement Note: This role offers the chance to tackle complex operational challenges at the forefront of clinical trial innovation. The growth opportunities are substantial for individuals who excel in problem-solving, technology management, and cross-functional leadership within the life sciences sector.

💡 Interview Preparation

Strategy Questions:

• "Describe your process for translating a complex clinical trial protocol into detailed eSource platform specifications. What are the key considerations?"

• "How do you ensure alignment and quality when managing an offshore team responsible for building the eSource platform? Provide specific examples of challenges you've overcome."

• "Walk me through a time you identified an inefficiency in a clinical trial data capture process and how you implemented a solution to improve it. What were the results?" Company & Culture Questions:

• "What interests you about Science 37's mission and its approach to decentralized clinical trials?"

• "How do you foster collaboration between technical teams (like platform builders) and clinical operations teams to ensure successful study design implementation?"

• "Describe a situation where you had to adapt your approach due to changing project requirements or client needs. How did you handle it?" Portfolio Presentation Strategy:

• CRIO Platform Showcase: Dedicate a significant portion of your presentation to demonstrating your proficiency with the CRIO platform. Highlight specific configurations, data capture elements, and how you utilized its features to meet study needs.

• Problem-Solution-Result Framework: For each case study, clearly articulate the problem (protocol requirement, operational challenge), your solution (design choices, process improvements), and the measurable results (efficiency gains, data quality improvements).

• Visual Aids: Use screenshots, workflow diagrams, or mock-ups to illustrate your designs and processes. Make it easy for interviewers to visualize your contributions.

• Storytelling: Frame your experiences as compelling narratives that showcase your expertise, problem-solving skills, and impact.

• Be Prepared for Deep Dives: Anticipate questions about the technical details of your designs, the rationale behind your choices, and how you managed any issues that arose.

📝 Enhancement Note: Interviewers will be looking for evidence of your practical, hands-on experience with eSource design and the CRIO platform, coupled with strong project management and communication skills. Your ability to articulate complex technical and operational concepts clearly and concisely will be key.

📌 Application Steps

To apply for this Clinical Study Design Manager position:

• Submit your application through the Science 37 careers portal via the provided Greenhouse link.

• Portfolio Customization: Tailor your resume and cover letter to highlight your specific experience with eSource platform design, CRF/ePRO development, and critically, your hands-on experience with the CRIO platform. Quantify achievements whenever possible.

• Resume Optimization: Ensure your resume clearly outlines your years of experience in clinical research and database capture software, with a strong emphasis on the required 2+ years of CRIO platform experience. Use keywords from the job description naturally.

• Interview Preparation: Practice articulating your experience using the STAR method (Situation, Task, Action, Result) for behavioral questions. Prepare to present your portfolio, focusing on case studies that demonstrate your eSource design expertise, process optimization skills, and experience managing offshore teams.

• Company Research: Familiarize yourself with Science 37's mission, values, and recent news. Understand their role in decentralized clinical trials and how this position contributes to their overall strategy.

⚠️ 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.

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