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- 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
- Serve as the subject matter expert (SME) for CTMS template design and eSource best practices
- 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
What We're Looking ForRequired Qualifications
- 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
- Excellent attention to detail with a focus on data accuracy, completeness, and usability
- Strong cross-functional collaboration and communication skills
Preferred Qualifications
- Experience leading or managing a team in clinical research operations or technical services
- Prior experience building or managing eSource systems or digital clinical workflows
- 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
- Experience supporting regulatory inspections or sponsor audits
New York pay range
$100,000-$130,000 USD
