Clinical Operations Application Support Specialist
vor 1 Woche
Arcondis is a global consulting company with an exclusive focus on the healthcare and life science industries. Headquartered in Basel, Switzerland, the company has a global footprint with offices in North America, APAC and across Europe. We have been managing challenges and solving problems for our clients in compliance, business processes, information technology, and digital transformation since 2001. Our focus lies in creating value through cross-functional, sophisticated delivery methodologies and intelligent implementation. Our clients love to work with us because of our unique skillsets, our pragmatic approach, and our will to win.
We are a medium-sized international consulting firm dedicated to Life Sciences, with a unique and inspiring culture. Our distinctive culture is the driving force behind our success; it is deeply rooted in our purpose and behaviors.
We are owned by a charitable Foundation; our key differentiator is that we contribute to social causes every year. This ethos is not just a part of our identity; it's our way of life. Our motto, "We make healthcare better," reflects the unwavering commitment we have to improving the lives of people through the work we do.
Our culture fosters collaboration, innovation, and a sense of community that sets us apart from the rest. We are living our values every day. Our leadership is expected to lead by example, demonstrating a dedication to our mission and values.
We embrace diversity and inclusivity, and we believe in giving back to the community. Together, we are not just consultants; we are agents of change, and our culture is the driving force behind our shared purpose.
Responsibilities- Provide application support to key users for Veeva clinical operations platforms, covering business functional operations, high-level data analytics, and change management.
- Manage Incident Management, Service Request support, and Problem Management to resolve issues efficiently.
- Lead Operational Change & Configuration Management, including system updates and validation processes.
- Support system data management activities such as master data management, ensuring data quality, security, and integrity, and implementing data-related changes.
- Serve as a technical liaison between operative master data handling, business units, and regulatory units.
- Develop and maintain User Requirement Specifications and Quality Control documentation in line with SOPs and processes.
- Analyze solution releases, align on process and data requirements, and author/execute test scripts.
- Conduct business operations impact assessments and implement industry best practices.
- Proactively engage the user community to ensure readiness for new regulatory and technical changes in Veeva Vault Clinical systems.
- Collaborate with IT teams and external vendors to troubleshoot technical issues and coordinate updates.
- Drive continuous improvement processes to enhance system functionality and user satisfaction.
- Bachelor’s or higher degree in a scientific discipline (e.g. computer science, information systems, engineering, mathematics, natural sciences, medical, or biomedical science)
- Knowledge of systems in the Clinical Operations domain, incl. eTMF and CTMS systems with demonstrated experience in managing support and demand needs for these systems
- 2+ years of relevant experience in Clinical Operations business domain, Clinical Operations business processes, and Data Management
- Ability to understand complex functional requirements/requests from business users and translate them into pragmatic and workable (technology) solutions
- Strong agile process management mindset and ability to provide customer-facing support to identify value drivers and continuous improvement of processes and solutions
- Experience with one or more of the following systems is desired: Veeva (Veeva Vault Clinical, eTMF, CTMS) or comparable software
- Nice to have:
- ITIL knowledge and certification
- Technical skills and deep functional knowledge of the processes and business operations in the Biopharma R&D domain Understanding of working in GxP environment
- Technical overview and understanding of OS, Cloud infrastructure, Databases (SQL queries), Middleware, Network, Storage and Backup
- Experience with: Release & Deployment Management, License management, Proactive monitoring of applications and jobs, Outage management, Application Documentation
- Experience with one or more of the following systems is nice to have: TIBCO Spotfire (preferably Exploratory platform), Lorenz docuBridge, Generis CARA, Userlane (Engagement Suite, Heart Analytics), Elluminate (eClinical Solutions), EGNYTE, Metworx, PleaseReview (Ideagen), SAS
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