Clinical Study Design Manager

📍 Job Overview

Job Title: Clinical Study Design Manager

Company: Science 37

Location: Boston, Massachusetts

Job Type: Full-time

Category: Clinical Operations / Life Sciences Operations

Date Posted: 2026-08-14

Experience Level: 3-5 Years

Remote Status: On-site

🚀 Role Summary

• Spearhead the definition and specification of eSource platform designs for clinical studies, ensuring seamless integration of protocol requirements and data capture needs.

• Manage the end-to-end lifecycle of the eSource platform, from initial conceptualization and detailed specification to final build and successful implementation.

• Provide expert oversight and guidance to offshore build teams, ensuring adherence to project timelines, technical specifications, and quality standards.

• Act as a Subject Matter Expert (SME) for eSource platform capabilities, data capture configurations, and validation processes within clinical trials.

• Drive operational efficiency by developing and implementing standardized templates, libraries, and streamlined build/QC processes.

📝 Enhancement Note: This role is critical for bridging the gap between clinical research protocols and the technical implementation of data capture systems. The emphasis on managing offshore teams and driving efficiency through standardization suggests a need for strong project management, technical understanding, and cross-cultural communication skills.

📈 Primary Responsibilities

• Define and document eSource platform design specifications, collaborating closely with internal cross-functional teams and external clients to ensure precise alignment with study protocols.

• Oversee the progress and quality of work performed by offshore build teams, ensuring all platform design and build milestones are achieved within agreed-upon project timelines and technical parameters.

• Serve as the primary subject matter expert (SME) for the eSource platform's functionalities, data capture configuration options, and the validation process.

• Champion operational efficiency by developing and implementing standardized eSource templates, component libraries, and contributing to the creation of streamlined build and quality control (QC) procedures.

• Actively participate in highly cross-functional project teams, engaging with clients, Site Operations Managers, and internal stakeholders to meticulously document data collection requirements.

• Develop, maintain, and monitor project timelines for all design activities, ensuring accountability for key quality metrics, Key Performance Indicators (KPIs), and performance benchmarks.

• Lead the build, rigorous testing, and successful implementation of direct data capture services, ensuring seamless system integration and successful User Acceptance Testing (UAT) to meet all quality deliverables.

• Contribute to the review and revision of Standard Operating Procedures (SOPs) and work instructions related to eSource platform design and build.

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

• Manage and perform user access provisioning and de-provisioning for all Science 37 eSource platforms, ensuring data security and compliance.

• Collaborate with Clinical Operations and Data Management teams to provide early strategic input on protocol design and to execute post-production changes effectively.

• Cultivate and maintain strong, collaborative working relationships with clients, sponsors, and vendors to ensure the successful execution of clinical research projects.

📝 Enhancement Note: The responsibilities highlight a blend of technical design, project management, quality assurance, and team leadership. The emphasis on "offshore teams" and "streamlined building and QC" points to a need for rigorous process management and quality control methodologies.

🎓 Skills & Qualifications

Education:

• Bachelor’s degree or equivalent applicable experience in a health science field is required. Experience:

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

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

• A minimum of 2 years of specific experience with the CRIO platform is a firm 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 regulatory guidelines.

• Proven ability to define and specify eSource platform requirements, aligning technical solutions with clinical protocol needs.

• Expertise in CRF and ePRO design principles and best practices.

• Proficiency with the CRIO platform, including its configuration and data management capabilities.

• Strong project management skills, with the ability to manage timelines, resources, and deliverables effectively.

• Excellent quality control (QC) and quality assurance (QA) mindset, with a focus on data integrity and accuracy.

• Ability to effectively manage and collaborate with offshore build teams, ensuring clear communication and task execution.

• Strong analytical and problem-solving skills, with a proactive approach to identifying and resolving issues.

• Excellent written and verbal communication skills, with the ability to articulate complex technical and clinical concepts clearly.

• Proficiency in Microsoft Office Suite and Google applications. Preferred Skills:

• Experience in drug development processes and understanding of regulatory compliance.

• Demonstrated ability to create and review clinical trial protocols, programs, and assess project success.

• Experience in building, guiding, and motivating cross-functional teams, leveraging diverse perspectives.

• Situational responsive decision-making capabilities.

• Ability to articulate ideas to both technical and non-technical audiences effectively.

• Proven ability to establish and maintain positive relationships with clients, sponsors, vendors, and internal teams.

• Exceptional time management, action-oriented, goal-oriented, and innovative approach.

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

• Familiarity with electronic clinical technologies beyond eSource platforms.

• Demonstrated ability to foster teamwork, cooperation, self-control, and flexibility to achieve project goals.

📝 Enhancement Note: The "2+ years of CRIO platform experience is required" is a very specific and critical requirement. The emphasis on offshore team management and standardized processes suggests that candidates with experience in global operations or managing distributed teams will be highly valued.

📊 Process & Systems Portfolio Requirements

Portfolio Essentials:

• eSource Design Case Studies: Showcase examples of eSource platform designs you have conceptualized and specified, detailing the protocol requirements addressed, data capture strategies implemented, and any unique challenges overcome.

• CRF/ePRO Design Examples: Provide samples or detailed descriptions of CRFs and ePRO questionnaires you have designed, highlighting your understanding of data integrity, user-friendliness, and regulatory compliance.

• Process Optimization Documentation: Include documentation of processes you have streamlined or improved, specifically related to eSource build, QC, or implementation, demonstrating efficiency gains.

• Project Management Artifacts: Present examples of project timelines, status reports, or risk assessments related to eSource platform development and implementation, showcasing your project management capabilities.

Process Documentation:

• Workflow Design & Optimization: Demonstrate experience in designing and documenting workflows for eSource platform build, testing, and deployment, with a focus on identifying bottlenecks and opportunities for improvement.

• Implementation & Automation: Provide evidence of your involvement in the implementation of eSource solutions, and any contributions you've made to automating build or QC processes.

• Measurement & Performance Analysis: Showcase how you have used metrics (KPIs, quality metrics) to measure the success of eSource platform designs and builds, and how you've used this data for continuous improvement.

📝 Enhancement Note: For this role, a portfolio should strongly emphasize practical examples of system design, process improvement, and project management within the clinical trial technology space. Demonstrating an understanding of how to manage and communicate with offshore teams will be crucial.

💵 Compensation & Benefits

Salary Range:

Based on industry benchmarks for a Clinical Study Design Manager role with 3-5 years of experience in a major metropolitan area like Boston, MA, the estimated annual salary range is $95,000 - $130,000. This estimate considers the specialized nature of eSource platform design, CRIO platform expertise, and the responsibilities associated with managing offshore teams.

Benefits:

• Comprehensive health, dental, and vision insurance plans.

• 401(k) retirement savings plan with company match.

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

• Opportunities for professional development, including training, conferences, and certifications.

• Life insurance and disability coverage.

• Potential for performance-based bonuses.

• Employee Assistance Program (EAP). Working Hours:

This is a full-time position, typically requiring approximately 40 hours per week. While the role is on-site, there may be some flexibility in daily start and end times, subject to team and project needs. Occasional evening or weekend work may be required to meet critical project deadlines or to coordinate with offshore teams in different time zones.

📝 Enhancement Note: The salary range is an estimate based on market data for similar roles in Boston, MA. Science 37 is a growth-minded company, so performance-based incentives or stock options could also be part of the compensation package, though not explicitly stated in the provided data.

🎯 Team & Company Context

🏢 Company Culture

Industry: Life Sciences / Healthcare Technology (specifically, decentralized clinical trials). Science 37 operates at the intersection of clinical research and technology, aiming to revolutionize how clinical trials are conducted by making them more accessible and efficient through technology.

Company Size: Science 37 is a growth-stage company, likely falling into the 201-500 employee range, indicating a dynamic and evolving work environment. This size often means opportunities for significant impact and direct influence.

Founded: Science 37 was founded in 2014, positioning it as an established innovator in the decentralized clinical trials space. This history suggests a company with a proven track record and a clear vision for the future of clinical research.

Team Structure:

• Operations Team: The Clinical Study Design Manager will likely be part of a broader Clinical Operations or Technology Solutions team, which may include other design specialists, build managers, project managers, and data managers.

• Reporting Structure: The role reports to a leader who provides general direction and guidance, indicating a level of autonomy and expectation for self-management. The reporting leader likely has oversight of multiple projects or a specific functional area within operations.

• Cross-functional Collaboration: This role is inherently cross-functional, requiring close collaboration with Client Services, Site Operations Managers, Data Management, Clinical Development, and external clients/sponsors. Effective communication and relationship-building are paramount.

Methodology:

• Data-Driven Design: Decisions regarding eSource platform specifications and data capture requirements will be driven by protocol details, regulatory requirements, and the need for robust, high-quality data.

• Process Standardization & Optimization: A key aspect of the role is to drive efficiency through the development and implementation of standardized templates, libraries, and streamlined build/QC processes.

• Agile Implementation: Given the fast-moving nature of a growth-stage company and clinical trial timelines, the approach to platform build and implementation likely incorporates agile principles, allowing for adaptability and iterative improvements.

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

📝 Enhancement Note: The company's focus on decentralized clinical trials suggests a culture that values innovation, technology adoption, and a patient-centric approach. The "growth-minded" aspect implies a need for adaptability and a willingness to contribute beyond a strict job description.

📈 Career & Growth Analysis

Operations Career Level: This role is positioned as a mid-level to senior individual contributor, requiring specialized technical and operational expertise in clinical trial technology design. It demands a strong understanding of both clinical research processes and system implementation.

Reporting Structure: The incumbent reports to a leader who provides general direction, implying a need for self-sufficiency and proactive problem-solving. The role is expected to perform duties with minimal supervision, indicating a high degree of trust and responsibility.

Operations Impact: The Clinical Study Design Manager has a direct impact on the efficiency, quality, and speed of clinical trial execution by ensuring that the eSource platform accurately captures critical data. This influences data integrity, regulatory compliance, and ultimately, the timely approval of new therapies. Their work is foundational to the success of decentralized clinical trials.

Growth Opportunities:

• Technical Specialization: Deepen expertise in eSource platform design, CRIO platform functionalities, and other clinical technologies, potentially leading to a Senior or Lead Clinical Study Design Manager role.

• Team Leadership: Transition into a management role, such as Platform Build Manager or a lead position overseeing a team of designers and builders, leveraging mentorship experience.

• Process Improvement Leadership: Take ownership of developing and implementing advanced operational strategies and automation initiatives within the Clinical Operations or Technology Solutions departments.

• Cross-functional Mobility: Opportunities to move into related areas like Clinical Data Management, Clinical Operations Management, or Product Management for clinical technology solutions.

• Industry Certifications: Pursue relevant certifications in clinical research, project management (e.g., PMP), or specific technology platforms to enhance professional credentials and expand knowledge base.

📝 Enhancement Note: The emphasis on training and mentoring junior staff suggests that leadership potential is valued and can be a pathway for career advancement within Science 37.

🌐 Work Environment

Office Type: This is an on-site position, indicating a traditional office-based work environment. Science 37 likely offers a modern office space designed to foster collaboration and productivity.

Office Location(s): The role is based in Boston, Massachusetts, a major hub for the biotech and pharmaceutical industries, offering access to a rich ecosystem of talent and innovation. The specific office location within Boston would need to be confirmed, but it's likely situated in an accessible area for commuters.

Workspace Context:

• Collaborative Environment: The office setting is expected to facilitate direct interaction and collaboration with colleagues from various departments, essential for aligning on study designs and problem-solving.

• Operations Tools & Technology: Access to standard office technology, as well as specialized clinical trial software, eSource platforms, and project management tools, will be provided to support daily tasks.

• Team Interaction: Regular team meetings, project huddles, and informal discussions will be part of the daily routine, enabling efficient communication and knowledge sharing.

Work Schedule: The standard work schedule is approximately 40 hours per week. While the role is on-site, the need to coordinate with offshore teams may necessitate occasional flexibility in daily hours to accommodate different time zones. This flexibility is key for global project success.

📝 Enhancement Note: As an on-site role in a growth-stage company, expect a dynamic and potentially fast-paced office environment. The Boston location offers significant advantages in terms of networking and career development within the life sciences sector.

📄 Application & Portfolio Review Process

Interview Process:

• Initial Screening: A recruiter or hiring manager will review your application and resume to assess alignment with the core requirements, particularly the years of experience in clinical research and specific platform expertise (CRIO).

• Technical Interview: Expect an interview focused on your technical knowledge of eSource/CRF/ePRO design, clinical trial processes, and your experience with the CRIO platform. You may be asked to discuss specific design challenges you've faced and how you resolved them.

• Case Study/Design Exercise: A practical exercise where you might be asked to design a section of an eSource form based on a given protocol snippet, or to outline your approach to a specific data capture challenge. This assesses your design thinking and problem-solving skills.

• Behavioral & Team Fit Interview: Questions will assess your ability to collaborate, manage teams (including offshore), handle pressure, communicate effectively, and fit within Science 37's culture. Prepare examples using the STAR method.

• Hiring Manager Interview: A final discussion with the direct manager to delve deeper into your experience, career aspirations, and how you can contribute to the team's success.

Portfolio Review Tips:

• Curate Select Examples: Choose 2-3 strong examples that best represent your experience in eSource design, CRF/ePRO development, and process improvement. Focus on quality over quantity.

• Highlight Impact & Metrics: For each case study, clearly articulate the problem, your solution, and the measurable impact (e.g., improved data quality, reduced build time, enhanced user experience). Quantify results whenever possible.

• Showcase Process Thinking: Explain your design methodology, how you ensure protocol alignment, and your approach to quality control and validation. Include examples of workflow optimization or standardization efforts.

• Address Offshore Management: If applicable, include examples of how you've successfully managed or collaborated with remote or offshore teams, highlighting communication strategies and project oversight.

• Prepare a Walkthrough: Be ready to present and walk through your portfolio items, explaining your role, decisions made, and lessons learned.

Challenge Preparation:

• Protocol Interpretation: Practice interpreting clinical trial protocols to identify data capture requirements and potential design challenges.

• System Logic: Be prepared to discuss the logic behind data capture rules, skip patterns, and data validation checks within an eSource system.

• Cross-functional Communication: Think about how you would explain technical design decisions to non-technical stakeholders (e.g., clinicians, study coordinators) and vice-versa.

• Efficiency Mindset: Be ready to discuss how you would approach standardizing build processes, creating libraries, and improving QC efficiency.

📝 Enhancement Note: The interview process will likely heavily weigh practical experience with eSource/CRF/ePRO design and specific platform knowledge (CRIO). Demonstrating an understanding of managing global teams and driving operational efficiencies will be key differentiators.

🛠 Tools & Technology Stack

Primary Tools:

• CRIO Platform: This is a core requirement. Deep expertise in configuring, designing, and managing studies within the CRIO platform is essential.

• eSource Platform: Proficiency with Science 37's proprietary eSource platform and its functionalities for data capture and study management.

• CRF/ePRO Design Tools: Experience with software or systems used for designing electronic Case Report Forms and electronic Patient-Reported Outcomes.

• Project Management Software: Tools such as Jira, Asana, Trello, or Microsoft Project for timeline management, task tracking, and team coordination.

Analytics & Reporting:

• Data Analysis Tools: Familiarity with tools for analyzing clinical trial data, potentially including Excel for basic analysis, and possibly more advanced tools if involved in data validation or QC reporting.

• Reporting Dashboards: Experience with creating or interpreting reports and dashboards that track study progress, data quality metrics, and project KPIs.

CRM & Automation:

• CRM Systems: While not explicitly mentioned, understanding how clinical trial data management integrates with broader CRM or CTMS (Clinical Trial Management System) functionalities can be beneficial.

• Workflow Automation: Experience with or understanding of how to automate repetitive tasks in the build, QC, or deployment processes for eSource platforms.

• Integration Concepts: Knowledge of how different clinical technology systems (e.g., EDC, ePRO, CTMS) integrate and exchange data.

📝 Enhancement Note: Proficiency with the CRIO platform is non-negotiable. Candidates should be prepared to discuss their practical experience with it. Familiarity with other EDC (Electronic Data Capture) systems and general clinical technology platforms will also be advantageous.

👥 Team Culture & Values

Operations Values:

• Patient-Centricity: A core value likely driving the mission to improve patient access to clinical trials. Operations professionals are expected to contribute to this mission through efficient and effective processes.

• Innovation & Agility: Science 37 operates in a rapidly evolving field. The company culture likely embraces new technologies and approaches, requiring operations professionals to be adaptable and forward-thinking.

• Quality & Compliance: Given the regulated nature of clinical research, a strong commitment to data integrity, accuracy, and adherence to regulatory guidelines (e.g., GCP, FDA) is paramount.

• Collaboration & Teamwork: The success of complex clinical trials relies heavily on effective collaboration across diverse teams and with external partners. A cooperative and supportive team environment is likely fostered.

• Efficiency & Speed: In a growth-stage company focused on accelerating research, a drive for operational efficiency and timely execution of tasks and projects is highly valued.

Collaboration Style:

• Cross-functional Integration: Expect a collaborative style where the operations team works closely with clinical, data management, and technology teams to achieve shared goals. Open communication channels are essential.

• Process Review & Feedback: A culture that encourages constructive feedback on processes and designs, fostering continuous improvement and learning.

• Knowledge Sharing: Encouragement of sharing best practices, lessons learned, and technical insights across teams, particularly when managing diverse projects and working with distributed teams.

📝 Enhancement Note: The company's mission to accelerate clinical research implies a culture that is both mission-driven and performance-oriented. Candidates should demonstrate how their operational approach aligns with these values.

⚡ Challenges & Growth Opportunities

Challenges:

• Managing Offshore Teams: Effectively communicating, coordinating, and ensuring quality control with build teams located in different time zones and potentially different cultural contexts presents a significant challenge.

• Balancing Standardization with Customization: Developing standardized templates and libraries while still accommodating unique protocol requirements for each study requires a strategic and flexible approach.

• Rapidly Evolving Technology: Keeping pace with advancements in clinical trial technology and integrating new tools or features into existing platforms can be demanding.

• Tight Project Timelines: Clinical trial timelines are often aggressive. Meeting design and build deadlines while maintaining high quality requires exceptional organization and prioritization skills.

• Stakeholder Management: Navigating the diverse needs and expectations of internal teams, clients, and sponsors requires strong communication and negotiation skills.

Learning & Development Opportunities:

• Advanced eSource & CRIO Training: Opportunities to gain deeper expertise in the CRIO platform and other advanced eSource functionalities.

• Decentralized Clinical Trials (DCT) Domain Expertise: Expanding knowledge in the rapidly growing field of DCTs, understanding the nuances of patient-centric trial design and execution.

• Project Management & Leadership Skills: Development opportunities in project leadership, team management, and process improvement methodologies.

• Industry Conferences & Networking: Potential to attend industry events related to clinical research technology, data management, and clinical operations.

• Mentorship Programs: Access to mentorship from senior leaders within Science 37 to guide career development and skill enhancement.

📝 Enhancement Note: The challenges inherent in managing offshore teams and balancing standardization with customization are key areas where candidates can demonstrate their problem-solving capabilities and strategic thinking.

💡 Interview Preparation

Strategy Questions:

• "Describe your process for translating a clinical protocol into detailed eSource platform specifications. How do you ensure all data capture requirements are met?" (Focus on methodology, documentation, and cross-functional input.)

• "How would you approach standardizing eSource build processes and creating reusable component libraries to improve efficiency?" (Highlight your experience with process optimization and template development.)

• "Discuss a time you had to manage a project with an offshore team. What were the challenges, and how did you ensure successful delivery and quality?" (Prepare a STAR method example focusing on communication, oversight, and problem-solving.) Company & Culture Questions:

• "What interests you about Science 37's mission and our role in decentralized clinical trials?" (Research the company's mission, values, and recent achievements.)

• "How do you stay updated on the latest trends in clinical trial technology and regulatory guidelines?" (Demonstrate your commitment to continuous learning.)

• "Describe your ideal work environment. How do you thrive in a fast-paced, growth-oriented company?" (Align your answer with Science 37's culture.) Portfolio Presentation Strategy:

• Structure: Organize your portfolio by project type or by the key responsibilities of the role (e.g., Design Specification, Process Improvement, Team Collaboration).

• Narrative: For each case study, tell a clear story: the challenge, your actions, and the results. Quantify outcomes whenever possible.

• Visuals: Use screenshots or diagrams where appropriate to illustrate eSource designs, workflows, or system configurations.

• Tool Focus: Clearly articulate your experience with the CRIO platform and any other relevant eSource/EDC systems.

• Q&A: Be prepared to answer detailed questions about your design decisions, project management approach, and problem-solving strategies.

📝 Enhancement Note: Be ready to demonstrate not just your technical skills but also your ability to lead, communicate, and drive efficiency in a complex operational environment. Highlighting your experience with the CRIO platform is critical.

📌 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.

• Tailor Your Resume: Ensure your resume clearly highlights your experience with clinical research, eSource/CRF/ePRO design, CRIO platform usage, and any experience managing offshore teams or improving operational processes. Use keywords from the job description.

• Prepare Your Portfolio: Curate your strongest examples of eSource design specifications, CRF/ePRO designs, process improvement initiatives, and project management artifacts. Be ready to present these effectively.

• Research Science 37: Familiarize yourself with Science 37's mission, values, and their approach to decentralized clinical trials. Understand their impact on patient access and research acceleration.

• Practice Interview Responses: Prepare for technical, behavioral, and situational questions, particularly those related to your experience with CRIO, offshore team management, and process optimization.

⚠️ 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.