Senior Coordinator, Interactive Response Technology - Hybrid

Job Description

Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

IRT & COA Senior Coordinator is responsible for providing end-to-end IRT (Interactive Response Technology) & COA (Clinical Outcome Assessment) systems project management support including, but not limited to, gathering study-specific user requirements, executing UAT tasks, managing project timelines, managing and enforcing IRT & COA systems Standards. IRT & COA Sr. Coordinator also monitors system change requests and acts as our Company’s IRT & COA systems subject matter expert while liaising with external vendors. Accountable for making decisions regarding IRT & COA process, issue resolution, and deviations from standards.

Applies IRT & COA systems expertise on day-to-day activities when issues are escalated. Communicates with internal and external stakeholders and escalates risks. May participate and lead in process improvement initiatives, standards development and maintenance. Responsible for creating and enforcing IRT & COA systems standards, managing vendor performance, and supporting training &education of stakeholders.

Primary Activities:

• Execute IRT & COA systems development process from kickoff to system go live, ongoing system change control, system closeout and database lock activities.

• Defines/redesigns IRT & COA development processes across vendor base. Identifies areas for process improvement and leads improvement activities.

• Creates and enforces the use of IRT & COA systems standards. Responsibilities may include creation / revision of IRT & COA systems standards, collaboration with vendors and internal stakeholders to define requirements, and monitoring standards utilization rate.

• Performs peer-review of the IRT & COA systems specific documentations for quality (e.g. comparing paper COA measures with Developer version etc.).

• Manages vendor performance and relationship(s). Responsibilities may include defining and implementing process with vendor representatives, monitoring and analyzing vendor and our Company's performance metrics, performing root cause analysis and identifying corrective actions, and serving as point of escalation for vendor issues.

• Obtains internal and external stakeholder feedback; this may include meeting with vendor project managers and/or meeting with subject matter experts or representatives from stakeholder functional areas

• Provides support for successful integration of our Company's and vendor systems

• Provides support for problem resolution between IRT & COA vendors and our Company's Clinical Trial Team

• May participate in training and education for stakeholders. May develop, or assist in development of, reference and/or training material. May provide cross-functional internal …