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Parexel is currently seeking a Clinical Digital Systems Analyst (Technical Administrator) to join us in either South Africa, Poland, UK, or Lithuania, dedicated to a single sponsor. This role will be responsible for optimizing Clinical trial processes by managing digital systems, bridging technology and operations and managing user systems access.
Job Responsibility:
Represents their department and collaborates with Information Services (IS) regarding the implementation and management of digital systems/technology used
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
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, TMF and other ‘platform’ systems)
User access lead on CTMS, eTMF, SharePoint and other Clinical Systems
Works closely with IS and the digital system providers, ensuring teams are trained appropriately in the relevant digital systems
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 3 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)
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
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:
Open and friendly work environment
Opportunities to develop long-term careers
Opportunity to develop within your role and tackle further responsibilities or develop your skill set within other related departments