Do you enjoy bringing structure, quality, and clinical technology together? Are you motivated by helping study teams work efficiently and ensuring that clinical trial systems and documentation are compliant and inspection-ready? If you like solving system-related challenges and contributing to continuous improvement, this role could be a great match for you.
At Sanos Integrated Solutions, we are looking for an experienced CTMS & eTMF Associate to join our Clinical Processes team for a 12-month maternity cover. You will become an important part of our Veeva ecosystem and support study teams across international clinical trials in a role with both operational responsibility and room to make a visible impact.
The position is intended to cover responsibilities currently handled by our CTMS Manager, so we are looking for someone who is comfortable working hands-on with clinical trial systems and documentation management, particularly within Veeva CTMS and Veeva eTMF.
The position
As CTMS & eTMF Associate, you will help ensure the smooth daily use, quality, and ongoing improvement of our Veeva clinical trial systems and documentation processes. You will collaborate with study teams, Clinical Operations, Quality Assurance, Data Management, Regulatory Affairs, IT, and external vendors to keep our systems and Trial Master Files compliant, complete, and inspection-ready throughout the study lifecycle.
You will join the Clinical Processes team, where we work together to make sure our systems, processes, and documentation support efficient study execution while maintaining high standards of quality, compliance, and inspection readiness.
What you will be working with
CTMS and eTMF responsibilities
- Maintain oversight of study setup, maintenance, and governance across Veeva CTMS and Veeva eTMF
- Support study teams with system configuration, operational use, filing practices, metadata quality, and document lifecycle management
- Perform data quality reviews, reconciliation activities, TMF completeness reviews, and health checks
- Monitor system compliance, completeness, TMF quality metrics, and inspection readiness throughout the study lifecycle
- Manage user access and user administration activities
- Investigate and resolve CTMS and eTMF system-related issues in collaboration with IT, QA, study teams, and vendors
Systems and process responsibilities
- Lead testing, validation, and implementation of new Veeva functionality and enhancements
- Assist with development and optimization of CTMS and eTMF-related processes
- Contribute to SOPs, work instructions, guidance documents, and training programs
- Maintain training materials, guidance documents, user support resources, and best practices aligned with regulatory requirements and the TMF Reference Model
- Deliver training to Sanos staff, contractors, and study team members
- Contribute to inspection-readiness and audit-preparation activities
- Act as a key contributor to continuous improvement initiatives across Clinical Processes
What you bring
Professional experience
- Degree in Life Sciences, Health Sciences, Information Science, Records Management, or a related field
- Minimum 1–3 years of experience working with Veeva CTMS and/or Veeva eTMF
- Experience working in clinical trials and GCP-regulated environments
- Strong understanding of Trial Master File requirements and the TMF Reference Model
- Experience with CTMS and eTMF administration, maintenance, and support
- Experience training end users and supporting system adoption
- Experience with User Acceptance Testing (UAT), validation, and system change management
- Excellent written and verbal communication skills in English
Personal strengths
- Highly structured and organized
- Service-minded and approachable
- Able to work independently while collaborating across functions
- Curious and eager to learn
- Proactive problem-solver comfortable taking owner ship of responsibilities.
- Adaptable and comfortable handling competing priorities
- Passionate about process optimization and operational excellence
Could we be a good cultural fit?
At Sanos, we are driven by science, collaboration, and the opportunity to make a meaningful difference for patients. We aim to create strong results through trust, shared responsibility, curiosity, and teamwork.
Our culture is built around three simple principles that shape how we work together:
- Take on – Responsibility is given, and we inspire you to take it.
- Try out – We encourage curiosity, learning, and the opportunity to explore diverse tasks and grow professionally.
- Team up – We do not just work together; we thrive together.
We trust you to bring your expertise, judgment, and ideas into play. In return, we offer a collaborative environment where you can develop professionally, contribute to continuous improvement, and make a real difference in how we deliver high-quality clinical trials.
What you can expect from us
- A 12-month maternity cover position in a growing clinical research organization
- A key operational role with responsibility across Veeva CTMS and Veeva eTMF
- Close collaboration with experienced clinical trial professionals across functions
- Exposure to international clinical trials and inspection-readiness activities
- The opportunity to contribute to process optimization, system improvements, and training initiatives
- A supportive and collaborative culture where knowledge sharing and professional development are valued
Interested in making an impact?
This is a 12-month maternity cover position based at our office in Søborg.
You will join a collaborative and knowledgeable team and gain exposure to a wide range of clinical development activities, systems, and stakeholders. This role offers a strong opportunity to deepen your expertise in Veeva CTMS, Veeva eTMF, clinical documentation, and clinical process management while contributing to global clinical trials.
If you would like to know more about the position, you are welcome to contact Anna Metnik, Associate Director, Clinical Processes, asi@sanos.com.
We look forward to hearing from you.
About Sanos Integrated Solutions
Sanos Integrated Solutions is part of the Sanos Group, a contract research organization dedicated to supporting biotech and pharmaceutical companies in bringing innovative treatments to patients.
We combine scientific expertise, operational excellence, and digital innovation to deliver high-quality clinical trial services. Our integrated approach supports clinical development activities across studies, systems, processes, and documentation, helping our partners conduct efficient, compliant, and patient-focused clinical trials.
At Sanos Integrated Solutions, we are committed to quality, collaboration, and continuous improvement. We work across disciplines and geographies to create solutions that support study teams, strengthen operational execution, and contribute to better outcomes for patients.
