Job Description
Applies 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 COA systems standards, managing vendor performance, and supporting trainingeducation of stakeholders.
Primary Activities
1. Execute COA systems development process from Kickoff to system go live, ongoing system change control, system closeout and database lock activities.
2. Defines/redesigns COA development processes across vendor base. Identifies areas for process improvement and leads improvement activities
3. Creates and enforces the use of COA systems standards. Responsibilities may include creation / revision of COA systems standards, collaboration with vendors and internal stakeholders to define requirements, and monitoring standards utilization rate
4. Performs peer-review of the COA systems specific documentations for quality (e.g.
comparing paper COA measures with Developer version etc.)
5. Manages vendor performance and relationship(s). Responsibilities may include defining and implementing process with vendor representatives, monitoring and analyzing vendor and Company performance metrics, performing root cause analysis and identifying corrective actions, and serving as point of escalation for vendor issues.
6. Serves as project manager of all COA 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 COA 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 we
📌 Clinical Outcomes Assessment (Munro)
🏢 Msd
📍 Munro