Description
The Decentralized Clinical Trail Analyst (DCTA) will support the Decentralized Clinical Trail Lead (DCTL) with project management activities to ensure all work is conducted in accordance with standard operating procedures (SOPs), policies and practices, good clinical practices (GCP), applicable regulatory requirements, and meets quality/timeline metrics.
Responsibilities:
- Assist in the establishment and maintenance of all project documentation, including files, records and reports according to the scope of work and SOPs.
- Assist with periodic review/audit of files for accuracy and completeness.
- Assist with the coordination and tracking of all information, communications, documents, materials, and supplies for assigned projects.
- Manage study specific eTraining and oversee compliance.
- Support the updating and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information.
- Organize and support DCTL in managing internal study team and customer meetings.
- Take and record minutes, notes and actions at assigned meetings, distribute and follow up accordingly.
- Support the preparation of presentation materials for meetings (internal/external) and project summary data.
- Support the coordination of project team and/or customer meetings, including logistics and materials required.
- Establish and manage performance dashboards, analyze event triggers and alerts and determine appropriate follow up for DCTL or others to act upon.
Qualifications:
- 2 years of prior relevant experience.
- Requires knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education.
- 1 year of relevant clinical research experience with analytical/financial skills or relevant Project Management experience or equivalent combination of education, training, and experience.
- Strong written and verbal communication skills, including good command of English language.