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Systems Analyst
hace 4 meses
Location:
Barcelona, Spain
Introduction to Role:
Are you ready to break new ground and leave a collective legacy? We are seeking a Systems Analyst for our Logistics and Clinical Supply (LCS) team.
In this role, you will plan and manage electronic systems to support all aspects of Investigational Medicinal Product (IMP) preparation, distribution, and reconciliation for assigned clinical studies.
You will also contribute to the operational effectiveness of LCS and support the development of appropriate electronic systems.Accountabilities:
- As Systems Administrator for the SmartSupplies Suite work with assigned project teams to plan and manage agreed clinical supply strategies:
- Support and enable Study Managers in their provision of forecasts for clinical demand
- Ensure effective management of packaging and label manufacturing requests and support accurate information transfer to internal and external stakeholders though LSC electronic systems
- Manage the IMP label generation and approval process ensuring that all IP labels are created and designed for consistency and meeting country regulatory requirements
- Participate in Randomization and Trial Management System (RTSM) development and User Acceptance Testing (UAT) as relates to clinical supplies for assigned projects, ensuring that IXRS systems meet LCS standards for clinical supply functionality
- Participate in the development of RTSM user requirement specifications and provide final approval of each system specification
- Develop integrations specification between PMD and IXRS
- Participate in UAT in support of clinical supply functionality, for all assigned clinical projects and provide final LCS approval as required for golive
- Support timely maintenance of current, accurate and complete IMP Systems records, ensuring that necessary information is filed to all relevant GXP repositories including Product Specification File (PSF) and Trial Master File (TMF).
- Collaborate effectively within LCS to support seamless systems interfaces and smooth performance of electronic systems activities for assigned projects.
- Maintain & expand close crossfunctional relationships to best support provision of appropriate Systems best practice for assigned projects
- Liaise closely with Quality Assurance (QA) to coordinate activities such as label approval, systems qualification and all activities expected in accordance with cGMP, GDP, GCP, & ICH guidelines
- Partner with stakeholder departments to ensure that any issues relating to LCS systems (such as interfaces with other electronic systems or business processes) are highlighted and options/recommendation are developed quickly for resolution
- Communicate internally and externally to AstraZeneca and vendors to support existing infrastructures and interfaces with SmartSupplies
- For assigned projects represent Systems Management activities in LCS Matrix and other project meetings as required. Otherwise support the LCS Study Manager by contribution to overall supply planning and effective use of electronic systems for stakeholder reporting etc.
- Assist in the review, and preparation of departmental SOPs, systems and processes to support maintenance, improvement and future growth of Systems Management best practice.
- Support development of LCS electronic systems including upgrades, development of new systems interfaces, and contribution to recommendation and review of next generation systems options
- Liaise with LCS members to provide training to support their interface with LCS electronic systems. Solicit user feedback and highlight to Technical Manager as appropriate as relates to potential challenges and opportunities that may impact on systems usage throughout the IMP supply chain
- Attend and actively participate in departmental meetings
- Participate where required in LCS departmental and/or assigned crossfunctional process improvement initiatives
- Mentor other members of staff (members of LCS, summer interns, rotational associates etc.) assigned to flexible roles within the Systems Management team, and provide backup support to other staff members as required
- Communicate effectively with assigned teams, BPD, and with all interfacing functions and relevant groups as required
Essential Skills/Experience:
- Requires a Bachelor's degree in basic or applied science or engineering, or equivalent level of training in service.
- Some prior experience and/or working understanding of cGMP, GCP, and ICH guidelines as relates to IMP labeling, packaging, and distribution is desirable.
- A general understanding of RTSM and clinical supply solutions is expected.
- Experience in the Biotechnology and/or Pharmaceutical industry is required.
- Ability to work in a dynamic environment and to collaborate and coordinate complex activities within crossfunctional project teams.
- Proficiency in electronic systems such as Inventory systems, Microsoft Outlook, Word, Excel, and Power Point is expecte
