Clinical Study Design Manager

About the role

In this role, you define the eSource platform specification design for assigned studies, ensuring protocol requirements translate into precise implementation plans. You own the end-to-end lifecycle of the eSource platform, from initial design and detailed specification through final build and deployment in a production environment. You bridge the gap between clinical protocol complexity and technical execution, translating scientific needs into functional data capture solutions. You serve as the primary subject matter expert for system capabilities and data configuration, validating that the eSource platform meets study quality standards. You lead and mentor offshore build teams to maintain alignment with timelines, technical specifications, and quality benchmarks. You drive efficiency through standardized templates and libraries while actively shaping streamlined building and quality control practices. You partner directly with clients and internal stakeholders to document data collection requirements and secure alignment. You establish and monitor project timelines, tracking design activity progress while upholding strict quality metrics and performance indicators.

Key facts

What you'll do

Define and specify eSource design requirements for each study, collaborating with internal teams and clients to guarantee protocol alignment and data integrity.

Work closely with offshore development teams to ensure all platform design and build milestones are met according to project timelines, technical specifications, and quality standards.

Serve as the primary subject matter expert for system capabilities, data capture configuration, and validation activities related to the eSource Platform.

Drive efficiency by creating and maintaining standard templates and libraries while contributing to the development of streamlined building methodologies and quality control processes.

Collaborate within highly cross-functional project teams, working with Clients, Site Operations Managers, and internal staff to document detailed data collection requirements and resolve ambiguities.

Create, monitor, and maintain project timelines for all design activities, tracking progress while remaining accountable for quality metrics, key performance indicators, and benchmarks.

Lead the build, testing, and implementation of direct data capture services, coordinating system integration and user acceptance testing to satisfy defined quality deliverables.

Participate in the review and revision of standard operating procedures and work instructions to ensure they reflect current best practices and operational realities.

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

Oversee and perform user access management for all Science 37 eSource platforms, ensuring appropriate permissions and compliance with security standards.

Partner with Clinical Operations and Data Management teams to provide early strategic input on protocol design and to execute required post-production changes efficiently.

Build and maintain effective working relationships with clients, sponsors, and vendors to align expectations, manage dependencies, and ensure project success.

Translate complex protocol requirements into detailed technical specifications that guide the implementation of eSource platforms and data capture strategies.

Monitor emerging clinical research technologies and methodologies to recommend improvements that enhance platform efficiency and user experience.

Requirements

The following qualifications are required and must be verified as part of the eligibility criteria.

You must possess a Bachelor's degree or equivalent experience in the health science field, demonstrating foundational knowledge relevant to clinical research operations.

You must have 3+ years of cumulative experience in clinical research or the life science industry, including at least 3 years dedicated to the design of CRF, ePRO, or other clinical trial database capture software.

You must have 2+ years of direct experience with the CRIO platform, demonstrating hands-on capability in configuration and management within this environment.

You must have extensive knowledge of the clinical research development process, including regulatory guidelines, ethical considerations, and compliance requirements.

You must have proven experience working in a fast-moving, growth-minded company, showing comfort with flexibility and adaptability as project requirements evolve.

You must demonstrate proactive problem-solving abilities, ensuring thorough follow-through on commitments and ownership of complex issues.

You must possess strong communication and presentation skills, both written and verbal, enabling clear articulation of technical concepts to diverse audiences.

You must be able to build and guide organizational teams effectively, leveraging diverse backgrounds and perspectives to achieve shared objectives while providing clear direction and accountability.

You must be able to articulate ideas to both technical and non-technical stakeholders, ensuring alignment and understanding across all levels of the organization.

You must have successful situational responsive decision-making skills, allowing you to navigate ambiguity and make timely, informed choices.

You must be able to create and review protocols, programs, and assessments related to project success metrics and outcome measures.

You must participate actively in contributing to and reviewing activities that support clinical trial success, including data collection strategy and operational execution.

You must have experience leading and mentoring junior team members, helping to establish a culture of excellence, learning, and operational speed.

Nice to have

Preference will be given to candidates who have experience building and guiding organizational teams with diverse backgrounds and perspectives.

Preference will be given to individuals who demonstrate proactive problem-solving abilities and successful situational responsive decision-making in complex environments.

Preference will be given to candidates who can articulate ideas effectively to both technical and non-technical stakeholders.

Practical notes

This role may involve travel to client sites or conferences as required by project needs.

Candidates must be available for collaboration during standard business hours, with flexibility to coordinate across time zones when working with offshore teams.

Visa sponsorship may be considered for qualified candidates depending on location and role requirements.