Lead and manage the eSource team to deliver high-quality, compliant, and operationally effective templates
Oversee daily operations, workload prioritization, and resource planning
Drive accountability within the team through clear expectations and performance management
Monitor performance metrics and KPIs related to template quality, turnaround time, and operational impact
Collaborate with Sr Director of Site Solutions to align team strategy with departmental goals
Support and execute the strategic vision for eSource and study template standardization across all studies and sites
Design and maintain comprehensive operational playbooks governing the creation, validation, and lifecycle management of CTMS templates
Ensure all templates (Study Shells, Financial Templates, eSource Templates) align with Clinical Research standards and GCP best practices
Own end-to-end QA/QC processes for all templates, ensuring readiness, completeness, accuracy, and usability prior to deployment
Establish and enforce template governance frameworks, including version control, validation protocols, and audit readiness
Build and manage timelines for template development aligned with regulatory and operational milestones (e.g., feasibility, study startup, SIV readiness)
Identify opportunities to streamline and standardize template development to reduce redundancy and improve efficiency across studies
Implement continuous improvement processes based on user feedback, audit findings, and operational performance metrics
Collaborate with cross-functional teams to ensure templates meet downstream workflow needs
Support training of cross-functional users
Support hiring, onboarding, and development of eSource team members
Requirements
By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need. About the Role
Bachelor’s degree in Life Sciences, Healthcare Administration, or a related field 5+ years of
experience in clinical research operations, CTMS management, or study startup
Strong knowledge of GCP, regulatory requirements, and clinical workflows Proven
experience developing and building SOPs, playbooks, or standardized operational frameworks •
Experience with RealTime SOMS/CTMS platform Demonstrated
experience in QA/QC, audit readiness, and validation of clinical research documentation or systems
Strong project management skills with the ability to manage timelines across multiple studies and stakeholders
Proven ability to define and track KPIs and drive performance outcomes
Experience leading or managing a team in clinical research operations or technical services Prior
Familiarity with clinical trial budgeting and financial templates •
Experience in multi-site research networks or site management organizations (SMOs) •
Experience with various CTMS platforms (e.g., CRIO, Medidata, or similar)
Knowledge of integration between CTMS, EHR (e.g., eCW), and other systems •
Benefits
Experience supporting regulatory inspections or sponsor audits New York pay range $100,000 — $130,000 USD
Contact
experience more accessible to you, please contact CandidateAccommodations@iterative.health.
Additional details
Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes.
The Iterative Health Site Network is a premier network of 100+ clinical research sites across the US and Europe, accelerating the path to market for novel therapies.
The Manager of the eSource team is accountable for owning and optimizing the development, quality and standardization of all CTMS study templates, including study shells, financial templates, and eSource templates.
This role ensures that all templates are compliant with Clinical Research and Good Clinical Practice (GCP) requirements, and operationally usable across sites and studies.
The manager drives the execution of scalable playbooks, monitors performance through defined KPIs, and supports alignment with Clinical Operation milestones.
The role serves as the primary owner for quality, readiness, and usability of all CTMS templates, as well as continuous improvement, while collaborating cross-functionally to support efficient study startup and execution.
This is a hands-on leadership role requiring both team management and direct contribution to template development, quality assurance, and process improvement. Responsibilities
Excellent attention to detail with a focus on data accuracy, completeness, and usability
Strong cross-functional collaboration and communication skills Preferred
experience building or managing eSource systems or digital clinical workflows