Business Systems Analyst

Portland, OR

A local company leading in randomization and trial supply management (RTSM) for the global life sciences industry is looking for a Business Systems Analyst to join their rapidly expanding team.  If you are a technical project manager with experience in clinical research and supply chain management, get in touch! 

WHAT YOU WILL BE DOING:

System Implementation

  • Partner closely with Client Services Lead in support of implementation of client RTSM applications to enable client start-up targets

  • Attend client meetings and design sessions

  • Log, track and drive resolution of functional and technical issues discovered during implementation and prior to go-live

  • Ensures adherence to required deliverables and milestones of Project Management SOP

  • Drive project specific validation activities including study testing, system setup and implementation activities,

  • Support system integration activities

System Operations

  • Develop, implement and oversee client communication plans, including service level agreements data management and support procedures, as per SOPs.

  • Support Client Services Lead in supplies consulting and analysis required

  • Customer Support point of escalation for any system or support issues where required; develop training materials and train Customer Support staff on study application support procedures and client standards.

  • Monitor study issues for trends to enhancement opportunities or additional training needs

  • Develop client governance materials and participate in client business reviews

  • Participate in client audits


MUST HAVES:

  • The position requires a minimum of 3 years of experience in the clinical research field, particularly clinical supplies operations, RTSM/IRT services delivery and eClinical systems implementation, or over 7 years of relevant system implementation experience in related industry. 

  • Software implementation and testing experience required in clinical research or supply chain related industry. Project management experience working with cross-functional business and technical teams as project lead is required.

  • Knowledge of US FDA Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) GCP regulations, Electronic Records; Electronic Signatures regulation (21 CFR Part 11) and EU Annex 11 is a plus.

  • A  bachelor’s degree in a life science, supply chain management, or information technology field, or equivalent experience.

  • Willing to travel up to 25% business travel, namely for on-site client visits in support of client specification development and client User Acceptance Testing.


NICE TO HAVES:

  • Clinical supplies forecasting and management experience is highly desired.

  • Supply chain certification or experience is a plus.

  • Experience with IRT/RTSM and clinical supplies forecasting/simulation tools is a plus.

  • Experience working with agile development methodology is a plus.

  • Leadership Competencies; Client focused, solutions focused, proactive, responsive, organized, highest quality deliverables. Excellent verbal and written communication skills.

Further information will be shared with qualified candidates.
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