Buenos Aires, Argentina
Santiago, Chile
Full time
R

Job Overview

Under general direction, manage all laboratory aspects of assigned clinical trial projects for a Customer or a specific program for a Customer. May have responsibility for a specific Customer, drug program, indication or drug compound. Acts as the main point of contact for the Customer after study award and throughout the entire study lifecycle (startup, maintenance, closeout). Ensures work is conducted in line with standard operating procedures, policies and good practices.

Essential Functions

Study Setup and Planning
- Facilitate seamless study set-up including Protocol and Budget review, leading meetings, develop and implement project plans, milestone, risk, issue and action logs. Partner with Study Setup team to ensure quality database set-up, oversee preparation of protocol specific documentation. Will prepare and present protocol-specific materials at Kick Off and Investigator meetings
- May participate in the proposal and business development process including bid defence meetings.



Support development of Customer standards

Study Activity Monitoring and Closeout
- Will monitor the Project Management Plan, timelines and deliverables, manage study documentation throughout the Project lifecycle including filing into eTMF, oversee study monitoring and reporting, conduct meetings to meet needs of the Study and Customer requirements
- Will manage study scope changes and budget monitor quality of the study and any service-related issues, implementing changes as required. Lessons learnt will be reviewed and shared

Proactive Lines of Communication
- Build and own the Customer relationship, facilitate communication, collaborate with all operational areas within the company
- Will serve as an escalation point for study level issues and will coordinate and triage study-specific issues
- Coordinates customer survey follow up and ongoing health checks to support Customer relationship building

Meetings,

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