Clinical Operations Application Support Specialist

2 days ago

Klang, Selangor, Malaysia Arcondis Group Full time

Your profile / requirements

  • 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
  • Veeva 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

Tasks and 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.

Why Arcondis

Arcondis will provide you with a highly professional environment embedded in a transparent and people-oriented culture that allows you to make a sustainable impact and to realize your potential. We offer you:

  • A permanent, full-time position within a dynamic and growing life sciences consulting firm.
  • Attractive salary package commensurate with experience, along with performance-based bonuses.
  • Opportunities for continuous learning, career development, and advancement within the company, with potential pathways into leadership roles.
  • The chance to work on cutting-edge innovation projects that impact the future of the life sciences industry.
  • A hybrid working model that supports both remote and in-office collaboration, promoting work-life balance.
  • Be part of a supportive, collaborative team that values diverse perspectives and fosters a culture of innovation.
  • Regular recognition of achievements through internal awards, career progression opportunities, and financial incentives.
  • Exposure to a vast network of industry experts and leaders, helping you build valuable connections in the life sciences sector.

If you are ready to join our exciting growth journey and possess the skills and attributes we are looking for, we encourage you to apply for this critical role. Your financial expertise will be instrumental in propelling Arcondis to new heights in the life sciences consulting field.

Arcondis is an equal opportunity employer and welcomes candidates from all backgrounds to apply.

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