Job Overview
In addition to the responsibilities of Clinical Systems Specialist I and II, this role is accountable for the global documentation, implementation, and maintenance of internal and external clinical systems and interfaces.
Working in accordance with Standard Operating Procedures (SOPs) and business requirements, the incumbent will develop innovative solutions and establish validation processes that enable systems staff to efficiently retrieve and produce data from designated clinical systems. These systems include, but are not limited to, InnTrax, IQVIA Site and Investigator Management System (SIP/IQVIA), Electronic Document Management (EDM), and InFORMant.
Key Responsibilities
Technical Leadership & Support
- Provide technical guidance and support to Clinical Systems Specialists (CSS I & II) on system deployment and interface development.
- Serve as a subject matter expert and consultant to the business, ensuring system requirements are feasible and aligned with operational needs.
- Act as team lead for application enhancements or special projects when required.
System Implementation & Maintenance
- Support the implementation of clinical systems and interfaces, including:
- Maintaining an up-to-date inventory of all systems and interfaces.
- Developing and maintaining standardized templates to ensure consistency across teams.
- Perform bug fixes and implement system enhancements as needed.
- Set up, maintain, and provide second-level technical support for assigned clinical systems (e.g., InnTrax, InFORMant, EDM).
Data Management & Reporting
- Develop, validate, and maintain ad-hoc queries in MS Access to meet business requirements.
- Maintain a centralized register of validated queries.
- Generate reports and metrics to support business decision-making.
Validation & Quality Assurance
- Review and approve validation documentation for system interfaces and queries.
- Participate in user acceptance testing, including:
- Executing and documenting test cases.
- Identifying and recording quality issues.
- Recommending and implementing solutions.
- Conduct quality control checks and provide reports to Project Managers (PMs) and Clinical Team Leads (CTLs) to ensure data integrity.
Training & Documentation
- Provide training, coaching, and support to Clinical Systems Specialists and system champions.
- Update training materials, standard forms, and documentation related to system processes and enhancements.
- Coordinate and support the rollout of training initiatives.
Compliance & Continuous Improvement
- Ensure adherence to all relevant SOPs, work instructions, and regulatory requirements.
- Contribute to the development of system specifications, processes, and documentation.
- Stay up to date with developments in clinical research, systems, and technologies.
- Understand and support financial and performance metrics at a regional or project level.
Qualifications
Education & Experience
- Bachelor’s degree in Health Sciences, Life Sciences, or a related field (required).
- 3–5 years of relevant experience, ideally within a clinical research environment.
- Strong experience working with clinical systems and data management processes.
- Equivalent combinations of education and experience will be considered.
Technical Skills
- Advanced proficiency in MS Word, Excel, and Access.
- Programming knowledge required, including:
- Strong understanding of clinical systems, system integrations, and interdependencies.
Core Competencies
- Strong problem-solving and analytical skills.
- Excellent communication and interpersonal skills.
- High level of organization and attention to detail.
- Ability to work independently and manage multiple priorities under tight deadlines.
- Capability to deliver system training and client presentations.
- Proven ability to build effective working relationships across cross-functional teams.
Additional Requirements
- In-depth understanding of SOPs, work instructions, and regulatory guidelines.
- Familiarity with IQVIA project structures and cross-functional team dynamics.
- Commitment to continuous learning and professional development.
