Senior Coordinator, Interactive Response Technology - Hybrid

MSD•Rahway, PA

5d•Hybrid

About The Position

The IRT Senior Coordinator is responsible for providing end-to-end IRT (Interactive Response Technology) systems project management support. This includes gathering study-specific user requirements, executing UAT tasks, managing project timelines, and managing and enforcing IRT systems standards. The IRT Sr. Coordinator also monitors system change requests and acts as the Company’s IRT systems subject matter expert while liaising with external vendors. They are accountable for making decisions regarding IRT process, issue resolution, and deviations from standards. They apply IRT systems expertise on day-to-day activities when issues are escalated, communicate with internal and external stakeholders, and escalate risks. The role may participate and lead in process improvement initiatives, standards development and maintenance. Responsibilities include creating and enforcing IRT systems standards, managing vendor performance, and supporting training and education of stakeholders.

Requirements

B.A. or B.S. degree required, preferably in life sciences, computer science, engineering or related discipline.
4 years’ of IRT working experience preferred.
Demonstrate knowledge of IRT systems development processes.
Knowledge of the clinical development process, preferably through submission; thorough knowledge of clinical data management.
Effective written and verbal communication skills.
Ability independently perform and manage multiple tasks at one time and meet deadlines in a complex environment working both internal and external to our Company.
Clinical Development
Clinical Information Systems
Communication
Data Management
Good Clinical Practice (GCP)
Interactive Response Technology
Project Management
Stakeholder Management
Standards Compliance
Teamwork

Nice To Haves

Deliverables Management
Identifying Risks
Project Management Operations

Responsibilities

Execute IRT systems development process from kickoff to system go live, ongoing system change control, system closeout and database lock activities.
Defines/redesigns IRT development processes across vendor base.
Identifies areas for process improvement and leads improvement activities.
Creates and enforces the use of IRT systems standards.
Responsibilities may include creation / revision of IRT systems standards, collaboration with vendors and internal stakeholders to define requirements, and monitoring standards utilization rate.
Performs peer-review of the IRT systems specific documentations for quality.
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 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 and external communication as needed.
May provide support for the development / maintenance of relevant documentation, including applicable SOPs, job aids, and guidance documentation.
May mentor new staff.
May lead a continuous improvement special project or any other project or perform any other IRT related task deemed appropriate by management.
Serves as project manager of all IRT systems activities for protocols assigned.
Uses interpersonal, negotiating, and project management skills to perform the following tasks: Project plan development, execution, and change control.
Coordinates resolution & risk mitigation of all IRT systems related issues and end of study vendor deliverables.
Activity definition and sequencing, duration estimation, schedule development, and schedule control.
Risk management planning (i.e., risk identification, analysis, and response planning, as well as risk monitoring and control).
Communication planning, information distribution, performance reporting, and project closure.