• Plan and manage electronic (technical) systems to seamlessly support all aspects of Investigational Medicinal Product (IMP) preparation, distribution and reconciliation for assigned clinical studies.
• Work collaboratively within Logistics and Clinical Supply (LCS), with external vendors, and with all other interfaces and stakeholders as required to ensure highly effective deployment of electronic systems for IMP management and supply
• Support development of appropriate electronic systems for LCS, including training of team members where necessary to enable simple operations to be undertaken as required
• Contribute to the operational effectiveness of Logistics and Clinical Supply
Major Duties and Responsibilities
• As Systems Administrator for the SmartSupplies Suite work with assigned project teams to plan and manage agreed clinical supply strategies:
o Support and enable Study Managers in their provision of forecasts for clinical demand
o Ensure effective management of packaging and label manufacturing requests and support accurate information transfer to internal and external stakeholders though LSC electronic systems
o 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
o Participate in the development of RTSM user requirement specifications and provide final approval of each system specification
o Develop integrations specification between PMD and IXRS
o Participate in UAT in support of clinical supply functionality, for all assigned clinical projects and provide final LCS approval as required for go-live
• 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 cross-functional 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 cross-functional process improvement initiatives
• Apply own training and expertise to effectively deliver against flexible assignments within other aligned LCS roles as required
• Mentor other members of staff (members of LCS, summer interns, rotational associates etc.) assigned to flexible roles within the Systems Management team, and provide back-up support to other staff members as required
• Communicate effectively with assigned teams, BPD, and with all interfacing functions and relevant groups as required
Requires a Bachelor’s degree in basic or applied science or engineering, or equivalent level of training in service. The Systems Analyst will also have appropriate direct experience working in a development or technical operations environment in the pharmaceutical, scientific or health care product industry. Specific experience in IMP management and/or distribution is desirable.
• 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 and prior experience in IMP management and supply through electronic systems is preferred
• Preferably will have a working knowledge of the biopharmaceutical drug development process
• Ability to work in a dynamic environment and to collaborate and coordinate complex activities within cross functional project teams
This position requires a highly organized individual who demonstrates personal flexibility, initiative and an ability to work with minimal direct supervision on a day to day basis. The Systems Analyst must possess excellent attention to detail, while also demonstrating skills for organizing, planning, coordination, teamwork, and communication (oral, written and interpersonal). Proficiency in electronic systems such as Inventory systems, Microsoft Outlook, Word, Excel and Power Point is expected.
This is a complex and interactive job requiring good communication skills, combined with the ability to troubleshoot a range of problems, and to recognize where it is necessary to draw in additional expertise. The position requires an individual who can achieve results through both formal and informal networks, and who can effectively multi-task across activities of varying priority. This individual will be an effective representative for Systems Management as the primary technical contact on assigned projects. The Systems Analyst will also have the skills appropriate to mentor and coach colleagues in relation to Systems Management activities where required.
It is expected that the Systems Analyst will work under general supervision. This individual will be expected to seamlessly follow agreed processes and SOPs. Work will be reviewed periodically for accuracy, completeness and soundness of judgements
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.