Provide support to the Project Manager and related team members by performing routine procedures and tasks associated with the day to day running of projects throughout the entire study lifecycle (e.g. start-up, maintenance and close-out). Ensure work is conducted in line with standard operating procedures, policies and good practices.
Essential Functions
- Study Setup and Planning: Support the Project Manager by attending meetings, preparing minutes and action logs, preparing protocol-specific laboratory instructions documents. Under supervision of the Project Manager oversee setup of protocol specific Laboratory Centralized Monitoring requirements
- Study Activity Monitoring and Closeout: Perform routine tasks across assigned studies including site loading, Investigator Portal access, kit shipments, monitoring day-to-day study performance, overseeing Laboratory Centralized Monitoring. Work with internal and external teams to manage timely resolution of queries and protocol questions, issues and escalations
- Use status reports, monitoring tools and outputs to pro-actively identify trends and provide feedback to internal and external teams on performance of Investigator sites and company services. Support the Project Manager with administrative study tasks
- Coordinate and communicate with relevant stakeholders, including leading Customer communications and activities during any times when the Project Manager is absent. Oversee Project Close-out
- Meetings, Initiatives and Training Activities: May represent company at internal and external meetings, participate in external and internal audits/inspections. As required will support study training with sites, CRAs and customers
- Ensure outputs are delivered in line with organizational standards, protocol specific requirements and Customer expectations
- High School Diploma or equivalent Req Or
- Bachelor's Degree Life sciences or related field Pref
- 1+ years relevant experience (Clinical, Medical or Healthcare industry preferred). Pref Or
- Equivalent combination of education, training and experience.
- Strong interpersonal, communication, organizational, and time management skills.
- Must be able to comply with all applicable standards as required by the company.
- Demonstrated ability to handle multiple competing priorities and utilize resources effectively.
- Demonstrated ability of critical thinking and problem solving.
- Strong written and verbal communication skills including good command of English language. In certain geographies where communication in local language is desired (e.g. Japan, China), excellent command of local language with reasonable proficiency in English preferred.
- Computer proficiency in word processing, presentation and spreadsheet applications.
- Demonstrated ability to work in a fast-paced environment highly desirable.
- Ability to establish and maintain effective working relationships with coworkers and managers.
