Clinical Operations Administrator

Solutions Delivery - Kosice, Frankfurt

About Arcondis

Arcondis is a global consulting company with an exclusive focus on the healthcare and life science industries, with their particularly demanding requirements on quality and regulatory aspects. We have been managing challenges and solving problems for our clients in the areas of compliance, business processes,

information technology, and digital transformation since 2001. We create 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.

About us

Open Position

Mission

Tasks and responsibilities

Provide support to key users for the Veeva eTMF/CTMS platforms
Manage clinical trial processes, electronic applications (i.e. Veeva) and corresponding data management
Work with IT and external vendors to troubleshoot technical issues and coordinate system updates
Manage and align solution releases e.g., process and data requirements
Lead business operations impact assessments and industry best practices implementation.
Support system configuration, customization and validation (CSV), including study templates (i.e. electronic Trial Master Files (eTMF), data fields and workflows)
Implement adaptation of the systems to the individual studies, including collaboration on the application
Maintain accurate and up-to-date documentation of processes, procedures, and system configurations
Maintain and optimize existing databases
Generate reports and metrics related to eTMF and Veeva system performance and compliance for management review
Oversee the Veeva system and serve as the primary point of contact for Veeva-related issues and inquiries
Manage user access, permissions, and training to ensure efficient and secure utilization of the Veeva platform

Studies

Your profile

You hold a Bachelor’s degree or higher in Sciences, Natural Sciences, Medicine, Computer Science or similar
Proven experience as a Clinical Operations Systems Administrator, Coordinator or similar role with expertise in configuring and managing Clinical applications (i.e. Veeva/eTMF)
Strong understanding of clinical operations processes, data management and electronic tools within the life sciences industry
Translate complex requests from business users into pragmatic solutions
Proficiency in system configuration and customization, including study templates (i.e. eTMF), data fields and workflows
Knowledge of Veeva and eTMF
Ideally, experience in some of these applications: Elluminate eClinical CDR, Veeva Clinical eTMF, Veeva Clinical CTMS, Veeva Clinical SSU, Metworx PK/PD
Self-motivation and ability to identify continuous improvements of processes and solutions
Intrinsic motivation to making healthcare better around the globe