Clinical Systems Analyst
Overview:
Emmes Group: Building a better future for us all.
Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma.Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.
We believe the work we do will have a direct impact on patients’ lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We’re looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company.If you share our motivations and passion in research, come join us!
Primary Purpose
The Clinical Systems Analyst supports the effective use of clinical trial systems that enable high-quality research and reliable study delivery across Emmes’ global portfolio. This role partners closely with Clinical Operations, Project Management, Biometrics, Quality, and IT to ensure that systems—particularly Veeva Clinical and resource management platforms—are configured, maintained, and used in a way that supports operational consistency, data integrity, and regulatory compliance.
The successful candidate brings hands-on systems experience, a strong understanding of clinical research operations, and a collaborative approach to problem solving.
Responsibilities:
- Clinical Systems Support
- Serve as a functional system administrator and subject matter resource for Veeva Clinical (e.g., Vault CTMS, eTMF, Study Startup), including user access, configuration, and routine maintenance.
- Support at least one resource management system used for staffing, capacity planning, or project oversight; assist with user setup, reporting, and ongoing system support.
- Coordinate with IT and external vendors on system updates, enhancements, and issue resolution.
- Work with clinical and project teams to understand operational needs and translate them into practical system solutions.
- Support standardized workflows while allowing appropriate flexibility for study-specific requirements.
- Assist in the development and maintenance of system documentation, user guides, and training materials.
- Provide responsive support to global users, including investigation and resolution of system issues.
- Support onboarding and training of new users to promote consistent and effective system use.
- Escalate complex issues appropriately and follow through to resolution.
- Support compliant use of clinical systems in accordance with ICH-GCP, 21 CFR Part 11, and internal procedures.
- Assist with audits and inspections by providing system documentation and explanations of system use.
- Participate in change control and validation activities in collaboration with Quality and IT.
Qualifications:
- Bachelor’s degree in Life Sciences, Information Systems, or a related discipline with 4 to 8 years of expereince (or equivalent experience).
- Demonstrated experience supporting Veeva Clinical in a clinical research environment.
- Experience with at least one resource management or project staffing system.
- Understanding of the clinical trial lifecycle and how systems support study execution.
- Clear communicator with the ability to work effectively across functions.
- Experience in a CRO or academic research organization supporting multiple studies or programs.
- Exposure to additional clinical systems (e.g., EDC, eTMF, RTSM).
- Familiarity with system validation, SOPs, and inspection readiness.
- Experience supporting global teams.
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