Business & Technology Capabilities Sr. Analyst

Brief Description

The Business & Technology Capabilities (B&TC) Sr. Analyst works closely with B&TC and GCDO colleagues, in collaboration with Information Services (IS) to support cross functional clinical study teams regarding the implementation and management of digital systems/technology used by GCDO including but not limited to Veeva Clinical Vault. The B&TC Sr. Analyst demonstrates a good understanding of Veeva Clinical Vault functionality. The B&TC Sr. Analyst works with the 'Performance and Training' function to facilitate the collation, visualization, analysis & storage of relevant metrics for GCDO to ensure optimal trial performance and aid continuous improvement

Essential Functions/Responsibilities

• Establishes and maintains, digital systems on behalf of GCDO primarily the Veeva Clinical Vault applications eTMF, CTMS, SSU and Site Connect, plus other Clinical Systems as required
• Carry out required activities in JV eTMF for all Clinical Vault/eTMF user access requests in accordance with the documented process
• Carry out required system maintenance in JV eTMF to ensure end users can perform their role in accordance with the documented process
• Works closely with Business owners and system owners of digital system including but not limited to Veeva Clinical Vault, to ensure GCDO teams are trained appropriately in the functionality of relevant digital systems
• 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 Clinical Vault functionality
• Collaborates with partner vendors, as needed, in relation to system knowledge sharing and utilization
• Collaborates with subject matter experts on development of relevant digital system training materials, QMS documentation, and Validation activities and documentation
• Maintains a sound familiarity with Jazz's systems and related processes

• Establishes and maintains, digital systems on behalf of GCDO primarily the Veeva Clinical Vault applications eTMF, CTMS, SSU and Site Connect, plus other Clinical Systems as required
• Carry out required activities in JV eTMF for all Clinical Vault/eTMF user access requests in accordance with the documented process
• Carry out required system maintenance in JV eTMF to ensure end users can perform their role in accordance with the documented process
• Works closely with Business owners and system owners of digital system including but not limited to Veeva Clinical Vault, to ensure GCDO teams are trained appropriately in the functionality of relevant digital systems
• 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 Clinical Vault functionality
• Collaborates with partner vendors, as needed, in relation to system knowledge sharing and utilization
• Collaborates with subject matter experts on development of relevant digital system training materials, QMS documentation, and Validation activities and documentation
• 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
• Organizes and delivers relevant specialist training sessions and workshops with a key focus on digital systems

• Required Knowledge, Skills, and Abilities

• IT-literate and passionate/experienced towards new technology and digital systems including, but not limited to Microsoft-based applications and Veeva Clinical Vault applications CTMS, eTMF, SSU and Site Connect
• 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
• Previous experience working in Veeva Clinical Vault as an end user, business, or system administrator
• Ability to effectively interface with CROs and software vendor
• Previous experience working in clinical trials, with emphasis on GxP and compliance
• Has a sound working knowledge of clinical operations, clinical processes, Trial Master File regulations medical terminology, global CROs and vendor management
• Excellent interpersonal and communication skills, both written and verbal
• Good time management and organizational skills
• Quality driven with a focus on attention to detail
• Ability to work independently and take initiative
• Flexible approach with respect to work assignments and new learning
• Ability to prioritize workload and manage multiple and varied tasks with enthusiasm
• Ability to work effectively in a matrix environment and to demonstrate, and foster, teamwork within the group, as well as across the organization

• Required/Preferred Education and Licenses

• A minimum of a BA/BS, preferably in the scientific/healthcare and/or technology field
• A minimum of 5 years of experience in clinical related technology for the pharmaceutical/biotechnology industry
• 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