This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
Parexel is currently seeking a Veeva Clinical Digital Systems Analyst to join us in either Poland, South Africa, UK, Hungary or Lithuania, dedicated to a single sponsor. This role will be responsible for optimizing Veeva Clinical trial processes by managing digital systems, bridging technology and operations. The role leads system implementations, performs analysis, ensures consistency, and drives innovation to enhance efficiency and data quality in clinical operations.
Job Responsibility:
Represents their department and collaborates with Information Services (IS) regarding the implementation and management of digital systems/technology used
Facilitates the design, development, production and delivery of digital systems to achieve operational excellence, optimize data quality and realize efficiencies wherever possible
Accountable for the delivery of digital systems, working alongside IS counterparts and other departments
Acts as a key point of contact between on any new digital systems, and as an expert advisor to the other business departments in these matters
Works with the ‘Performance and Training’ function to facilitate the collation, visualization, analysis & storage of relevant metrics to ensure optimal trial performance and aid continuous improvement
Organizes and delivers relevant specialist training sessions and workshops with a key focus on digital systems
Identifies new technologies that may be relevant, assists with building business cases, ROI, etc. to support need for implementation
Ensures global consistency of approach for digital systems and technologies between clinical trials by increasing awareness of those systems/technologies
Establishes, maintains, reviews and manages the digital systems (e.g. CTMS, other ‘platform’ systems)
Lead on CTMS, eTMF, and other Clinical Systems management
Works closely with IS and the digital system providers, ensuring teams are trained appropriately in the relevant digital systems
Works as the lead to allow IS to ensure business functions are represented on any new digital system whose implementation is relevant
Provides mentorship, coaching, and hands-on training for staff in relation to Veeva Clinical digital systems. Maintains a sound familiarity with Jazz’s systems and related processes
Identifies improvement opportunities related to digital systems and assists with developing enhancement plans and roadmaps
Collaborates with other functional areas/departments and key stakeholders to maximize the utilization of the digital systems (e.g. creating dashboards, reports, ensuring best use of all CTMS functionality, ensuring best use of subscription databases)
Collaborates with partner vendors, as needed, in relation to system knowledge sharing and utilization
Collaborates with subject matter experts on development of relevant training materials, QMS documentation, and Validation activities and documentation
At least 5 years of experience in clinical related technology for the pharmaceutical/biotechnology industry
IT-literate and passionate/experienced towards new technology and digital systems (e.g. Microsoft-based applications, LMS, CTMS, eTMF, clinically focused subscription databases)
An experienced clinical trials professional who is well versed in the field of clinical study management activities, combined with excellent project management, training & mentoring capabilities
Extensive pharmaceutical or related industry experience
Substantial previous clinical trials experience, with emphasis on GxP and compliance
Has a sound working knowledge of clinical operations, clinical processes, medical terminology, global CROs and vendor management
Knowledge of FDA/ICH guidelines and industry standard practices regarding the management of clinical trial data and studies
Working knowledge of FDA Guidance Documents: Computerized Systems Used in Clinical Trials, General Principles of Software Validation
Working knowledge of 21 C.F.R. Part 11
Excellent interpersonal, verbal and written communication skills and ability to effectively interface with CROs and software vendor partners
Ability to work independently and take initiative
Ability to handle highly complex projects/task and work effectively in a matrix environment
What we offer:
participation in Parexel’s annual performance-based bonus plan
annual salary review
total rewards incentives
open and friendly work environment
opportunities to develop long-term careers
develop within your role and tackle further responsibilities or develop your skill set within other related departments