Senior eTMF Migration & Clinical Systems Integration Specialist
We are seeking a Senior
eTMF Migration & Clinical Systems Integration Specialist to deliver
end-to-end eTMF migration and clinical systems implementation activities within GxP-regulated environments.
The ideal candidate
brings strong hands-on experience in eTMF migrations, a solid
understanding of the clinical systems ecosystem, and a results-oriented
approach focused on data integrity, compliance, and inspection readiness.
Experience with Veeva Vault eTMF is highly preferred.
The role also contributes
to the standardization and industrialization of migration and validation
activities through reusable assets and best practices.
Responsibilities:
- Lead end-to-end
eTMF migrations, including strategy, taxonomy alignment, metadata
mapping, QC, and reconciliation
- Ensure inspection-ready
TMF structures and regulatory compliance
- Support
implementation and integration of clinical systems (eTMF, EDC,
CTMS, eCOA / ePRO, connected devices)
- Translate business
requirements into functional and integration specifications
- Support CSV
activities, system configuration, and data flow design
- Act as operational
point of contact for assigned projects or workstreams
- Provide project
status updates and manage risks and issues
- Contribute to presales
activities and mentor junior team members
Required
Skills:
- Strong hands-on
experience in eTMF migration (mandatory)
- Deep knowledge of TMF
structure, governance, and TMF Reference Model
- Experience with clinical
systems integration and clinical trial processes
- Knowledge of GxP
regulations, ICH-GCP, and inspection expectations
- Understanding of CSV
lifecycle and data quality principles (ALCOA+)
- Experience with Veeva
Vault eTMF strongly preferred
- Degree in Life
Sciences, Engineering, or related field
- 4–7+ years of
experience in Clinical Systems, TMF Management, or Clinical Operations
Desired Soft
Skills:
- Strong stakeholder
management and communication skills
- Structured,
quality-driven, and delivery-focused mindset
- Ability to work
autonomously while collaborating across teams
- Problem-solving
attitude and mentoring capability
What We Offer:
At Arithmos, we
value personal and professional growth, offering opportunities to work on complex,
high-impact clinical technology projects.
You will collaborate with
experienced professionals in an international environment, contributing to
solutions that support clinical excellence and regulatory compliance.
We offer flexible work
policies, a competitive compensation package, and continuous professional
development opportunities.