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 Portland, OR 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.
