Leads analysis, defines and establishes design of all technical aspects or provides technical expertise for IT solutions on complex IT systems projects within area of expertise.
Maintains and uses knowledge of solutions and IT landscape to explore and identify possible solutions related to defined technical problems, and finds opportunities to improve business solutions support.
Maintains and partly creates elements of large/complex solutions.
Reports to Global Development Operations Systems Head.
Support the development of systems roadmaps with business partners for Global Development Operations.
Acts as IT system technical expert for identified systems/applications.
Acts as primary contact with applicable software vendors and knowledge expert regarding vendor application roadmap and support escalation processes.
Provides technical expertise/knowledge in support of key projects.
Primary IT interface with key vendors providing IT solutions and/or support for Global Development Operations.
Has an understanding of current & future regulatory requirements and industry trends and assess the impact on business process and systems.
EDUCATION, EXPERIENCE AND SKILLS:
Experience with formal SDLC methodology.
Excellent ability to work independently but seek management support and guidance as needed.
Excellent skills in building multi-cultural relationships via strong collaboration and communication skills.
Technical knowledge/expertize of streamlining Clinical Development applications' data flow in light of business process changes strongly desired
Technical knowledge/expertise of applications such as CTMS, eTMF strongly desired.
Tecnical knowledge/expertize of the newest technology innovation such as Machine Learning for Clinical Development desired
Experience supporting Development Operations strongly desired.
Experience supporting global business functions, supporting large, complex and/or global applications and implementing global and/or large applications strongly desired.
Experience with system validation processes and validated systems governed by the Food and Drug Administration (FDA) regulations and International Council for Harmonisation (ICH) strongly desired.
Previous experience with application outsourcing and/or vendor management strongly desired.
Previous experience in IT support of R&D development such as Clinical Operations, Regulatory, Data Management, PV/Safety, etc. desired.
Overall understanding of the Pharmaceutical Development processes desired
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