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:
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
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
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.