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Jazz Pharmaceuticals · 1 day ago

Business & Technology Capabilities Sr. Analyst

Philadelphia, PA

Full-time

Onsite

Mid, Senior Level

$100K/yr - $150K/yr

5+ years exp

Jazz Pharmaceuticals is a global biopharma company dedicated to developing life-changing medicines for serious diseases. The Business & Technology Capabilities Sr. Analyst will support cross-functional clinical study teams in the implementation and management of digital systems, primarily focusing on Veeva Clinical Vault, to enhance trial performance and continuous improvement.

BiotechnologyHealth CarePharmaceutical

No H1B

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

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

Qualification

Veeva Clinical VaultClinical trial managementProject managementFDA/ICH guidelinesGxP complianceInterpersonal skillsTime managementAttention to detailTeamworkFlexibility

Required

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

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