Technical Administrator – Clinical Digital Systems Analyst
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Job Description
Clinical Digital Systems Analyst managing digital systems to optimize clinical trial processes at Parexel. Collaborating with various departments and ensuring consistency in digital technologies.
Responsibilities:
- Optimize clinical trial processes by managing digital systems, bridging technology and operations and managing user systems access.
- Collaborate with Information Services (IS) regarding the implementation and management of digital systems/technology used.
- Work 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.
- Ensure global consistency of approach for digital systems and technologies between clinical trials.
- Establish, maintain, review and manage digital systems (e.g. CTMS, TMF and other ‘platform’ systems).
- User access lead on CTMS, eTMF, SharePoint and other Clinical Systems.
- Work closely with IS and digital system providers, ensuring teams are trained appropriately in the relevant digital systems.
- Identify improvement opportunities related to digital systems and assist with developing enhancement plans and roadmaps.
- Collaborate with other functional areas/departments and key stakeholders to maximize utilization of the digital systems (e.g. creating dashboards, reports, ensuring best use of all CTMS functionality).
- Collaborate with partner vendors, as needed, in relation to system knowledge sharing and utilization.
- Collaborate with subject matter experts on development of relevant training materials, QMS documentation, and Validation activities and documentation.
Requirements:
- Bachelor’s degree, science, healthcare and/or technology preferred.
- 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.
Benefits:
- long-term job security
- professional development opportunities
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