Clinical Systems & Technology Associate

The role

The System Owner for assigned clinical system management including but not limited to eTMF and CTMS is accountable for the full lifecycle of HIRO’s electronic Trial Master File (eTMF) and Clinical Trial Management System (CTMS) platforms – from development and implementation through training, ongoing maintenance, and performance analysis. This role ensures both systems remain inspection-ready, support cross-functional trial teams effectively, and evolve alongside HIRO’s clinical operations needs.

The System Owner acts as the primary point of accountability for system configuration decisions, vendor relationships, data quality, and user enablement across the organization.

This role is home-based in Romania .

Key Responsibilities

• Supports the eTMF and CTMS build, document/artifact taxonomies, milestone and metadata configuration, workflow rules, user roles, and permissions.
• Translate clinical operations and regulatory requirements into system configuration specifications.
• Evaluate and prioritize system enhancements, working with software vendors to scope and validate changes.
• Manage vendor relationships for both platforms, release planning, and service-level performance.
• Lead implementation and rollout of new modules, releases, and configuration changes, including validation and user acceptance testing and periodic reviews.
• Own integration points between eTMF/CTMS and support adjacent clinical systems (e.g., EDC, safety, regulatory information management), coordinating with IT and system owners of connected platforms.
• Ensures that CSV procedures are aligned and deployed in accordance with internal policies.
• Coordinates and manages all issues relating to information security and/or data protection as a whole, providing appropriate responses and action plans in the event of risk.
• Ensures adequate resources and planning by implementing appropriate prevention plans for any future risks.
• Support development and maintenance of SOPs, work instructions, and system validation documentation governing eTMF and CTMS use.
• Partner with Quality to ensure implementations meet GxP, 21 CFR Part 11, and applicable data integrity requirements.
• Support delivery of role-based training for functional users.
• Support creation and maintenance of training materials, quick-reference guides, and onboarding content as systems evolve.
• Serve as the internal escalation point for user questions and provide ongoing coaching to super-users across functions.
• Monitor system health and data quality.
• Produce regular reporting and dashboards on system usage, TMF health, and CTMS data quality for executive stakeholders.
• Manage the transfer, retirement, and archival of system configurations and documentation.
• Complete HIRO administrative tasks as required e.g., timesheets, CV and training updates.
• Participate in regulatory audits and inspections as required.

Preferred Experiences and Skills

• Bachelor’s degree in life sciences, health information management, or a related field, or equivalent experience.
• 5+ years of experience in clinical trial operations, with direct ownership of an eTMF and/or CTMS platform.
• Working knowledge of ICH-GCP, 21 CFR Part 11, and TMF Reference Model standards.
• Experience managing software vendors, system configuration, and validation activities in a regulated environment.
• Demonstrated ability to design and deliver training to cross-functional, non-technical audiences.
• Strong analytical skills, with experience building metrics and reporting on system or data quality.
• Experience with a specific eTMF/CTMS platform (e.g., Veeva Vault, Oracle Siebel CTMS, Medidata Rave) is desirable.
• Prior experience integrating clinical systems (EDC, safety databases, RIM) with eTMF or CTMS is desirable.
• Fluency in oral and written English, with solid capability in writing medical and scientific materials or content.
• Experience supporting regulatory inspections or sponsor audits involving the TMF is desirable.