Clinical Trial Project Manager

Abstra; Buenos Aires; Hybrid; ARS 90,873,000 - 151,455,000; Full time

Job summary

Abstra is seeking a Clinical Trial Project Manager to oversee laboratory activities for multi-site trials across Argentina and Chile. You will lead startup, monitoring and closeout, coordinate with customers and internal teams, and ensure adherence to SOPs and GCP guidelines.

The role requires strong planning, risk management and proactive communication with investigators, sites and stakeholders to deliver study milestones on time and within budget.

Responsibilities

• 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
• 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
• 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
• Will represent the company at Investigator meetings and other internal / external face to face meetings. Will participate in audits and inspections as required
• Will provide study training to sites, CRAs and customers
• Will establish regular lines of communication with sites to manage on-going project expectations and issues. Will participate in improvement projects as needed
• Will assist in training of less experienced staff.

Job description

Abstra is seeking a Clinical Trial Project Manager to oversee laboratory activities for multi-site trials across Argentina and Chile. You will lead startup, monitoring and closeout, coordinate with customers and internal teams, and ensure adherence to SOPs and GCP guidelines.

The role requires strong planning, risk management and proactive communication with investigators, sites and stakeholders to deliver study milestones on time and within budget.