4G Careers

Business System Analyst
Technical Project Manager

Business Systems Analyst / Technical Project Manager


Recognized as one of Fortune's 2018 Best Workplaces in Bio/Pharma, 4G Clinical has an opening for a full-time Business Systems Analyst at our Wellesley, MA office.  

Responsibilities include, but are not limited to:

  • 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 SOPs
  • Drive project specific validation activities including study testing, system set-up and implementation activities
  • Support system integration activities, including configuration and change control 
  • Develop, implement and oversee client communication plans, including service level agreements data management and support procedures, as per 4G Clinical 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  
 

Qualified candidates will possess:

  • Minimum of 3 years of experience in the clinical research field, particularly clinical supplies operations, RTSM/IRT services delivery and eClinical systems implementation, or 7+ years of relevant system implementation experience in a related industry
  • Software implementation and testing experience in clinical research or a supply chain related industry 
  • Project management experience working with cross-functional business and technical teams, preferably as project lead
  • A Bachelor's Degree in a life science, supply chain management, an information technology field, or equivalent experience 

Additional skills preferred:

  • 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
  • Clinical supplies forecasting and management experience
  • Supply chain certification or experience
  • Experience with IRT/RTSM and clinical supplies forecasting/simulation tools
  • Experience working with agile development methodology 

Candidates must possess excellent verbal and written communication skills. This position requires up to 25% business travel.

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