Business & Technology Capabilities Sr. Analyst

Jazz Pharmaceuticals, Inc.; Barrow-in-Furness; On-site; GBP 45,000 - 60,000; Full time

Job summary

A global biopharmaceutical company in Barrow-in-Furness is looking for a Business & Technology Capabilities Sr. Analyst. This role involves establishing and maintaining digital systems, particularly Veeva Clinical Vault, and requires strong project management and communication skills. Candidates should have over 5 years of experience in pharmaceutical technology and be proficient with clinical study management procedures. This is an opportunity to contribute to efficient trial performance and system improvements.

Qualifications

• Experienced with Veeva Clinical Vault as an end user or system administrator.
• Minimum of 5 years experience in clinical-related technology.
• Knowledge of FDA/ICH guidelines on clinical trial management.

Responsibilities

• Establish and maintain digital systems for GCDO.
• Conduct system maintenance for user access requests.
• Train GCDO teams on digital systems functionality.
• Collaborate with key stakeholders to maximize system utilization.
• Identify improvement opportunities for digital systems.

Skills

IT-literate with digital systems

Clinical study management

Project management

Excellent communication skills

Attention to detail

Ability to work independently

Teamwork and collaboration

Education

BA/BS in scientific/healthcare or technology field

Tools

Veeva Clinical Vault

Microsoft-based applications

Job description

Overview

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 and technology used by GCDO, including but not limited to Veeva Clinical Vault. The analyst demonstrates a good understanding of Veeva Clinical Vault functionality and works with the Performance and Training function to facilitate the collation, visualization, analysis, and storage of relevant metrics for GCDO to ensure optimal trial performance and aid continuous improvement.

Essential Functions & Responsibilities

• Establish and maintain digital systems on behalf of GCDO, primarily the Veeva Clinical Vault applications (eTMF, CTMS, SSU, Site Connect) and 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.
• Perform required system maintenance in JV eTMF to ensure end users can perform their roles in line with documented procedures.
• Work closely with business owners and system owners to ensure GCDO teams are trained appropriately on the functionality of relevant digital systems.
• 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 Clinical Vault functionality).
• Engage partner vendors, as needed, for system knowledge sharing and utilization.
• Collaborate with subject‑matter experts on the development of relevant training materials, QMS documentation, and validation activities and documentation.
• Maintain familiarity with Jazz’s systems and related processes.
• Identify improvement opportunities related to digital systems and assist with developing enhancement plans and roadmaps.
• Organize and deliver specialist training sessions and workshops with a key focus on digital systems.

Qualifications

• IT‑literate and experienced with new technology and digital systems, including Microsoft‑based applications and Veeva Clinical Vault applications (CTMS, eTMF, SSU, Site Connect).
• Experienced clinical trials professional well‑versed in clinical study management activities, with strong project management, training, and mentoring capabilities.
• Previous experience working in Veeva Clinical Vault as an end user, business user, or system administrator.
• Ability to effectively interface with CROs and software vendors.
• Experience in clinical trials, with emphasis on GxP and compliance.
• 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, foster, and promote teamwork within the group and across the organization.
• Minimum of a BA/BS, preferably in the scientific/healthcare and/or technology field.
• Minimum of 5 years of experience in clinical‑related technology for the pharmaceutical/biotechnology industryli>
• 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.