Business Systems Analyst
The Business Systems Analyst is involved in supporting system integration activities, ensuring adherence to required deliverables, monitoring study issues for trends to enhancement opportunities and participating in client audits.
- Partnering closely with Client Services Lead in support of implementation of client Randomization and Trial Supply Management (RTSM) applications to enable client start-up targets;
- Attending client meetings and design sessions;
- Logging, tracking and driving resolution of functional and technical issues discovered during implementation and prior to go-live;
- Ensuring adherence to required deliverables and milestones of Project Management SOP;
- Driving project specific validation activities including study testing, system setup and implementation activities;
- Supporting system integration activities, including configuration and change control.
- Developing, implementing and overseeing client communication plans, including service level agreements data management and support procedures, as per SOPs.
- Supporting Client Services Lead in supplies consulting and analysis required.
- Customer Support point of escalation for any system or support issues where required; developing training materials and train Customer Support staff on study application support procedures and client standards;
- Monitoring study issues for trends to enhancement opportunities or additional training needs;
- Developing client governance materials and participating in client business reviews;
- Participating in client audits.
Qualifications and Experience:
- A Bachelor’s Degree in a life science, supply chain management, an information technology field, or equivalent experience;
- 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;
- 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 in English. Any other language would be an asset;
- Relevant working/residency permit or Swiss/EU-Citizenship required;
- This position requires up to 25% business travel.