This role is remote and can be worked by any suitable person located on the East or West coast.
Company Description
Our client is an exciting scale up Software Solutions Provider working at the cutting edge of clinical trials technology. Based in Boston, this newly created permanent role will be a fantastic opportunity to become part of a company with an aspirational culture, a defined career path and a leadership team who are open to new ideas and like to say yes! We are looking for a competent individual with excellent technical experience gained in a clinical operation, service delivery or implementation environment.
RESPONSIBILITIES
Key Accountabilities of the Business Systems Analyst / Technical Project Manager include the following:
System Implementation
- Partner closely with Client Services Lead in support of implementation of client RTSM applications to enable client start-up targets
- 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,
System Operations
- Develop, implement, and oversee client communication plans, including service level agreements, data management and support procedures, as per the company 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
REQUIRED EXPERIENCE
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 a 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.
EDUCATION AND/OR CERTIFICATION REQUIREMENTS
The candidate must possess at minimum a bachelor’s degree in a life science, supply chain management, or information technology field, or equivalent experience.
OTHER SKILLS/REQUIREMENTS
- 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.
- Up to 25% business travel, namely for on-site client visits in support of client specification development and client User Acceptance Testing.