Total 2 job vacancies by PSI CRO

In this role you will streamline activities of project teams and ensure consistency of Clinical Operations processes across Asia Pacific region. You will ensure meeting study milestones by project teams on a country level, report study progress to clients and global stakeholders.

The scope of responsibilities will include:

• Act as project management contact for the project team and PSI support services.
• Perform study status review and progress reporting, collect and report project status updates.
• Develop and update project planning documents, essential study documents and project manuals/ instructions.
• Ensure that the project timelines and subject enrollment targets are met.
• Coordinate maintenance of study-specific and corporate tracking systems.
• Oversee site selection and startup, site contractual and budget negotiations.
• Supervise project team and site training, perform field training of monitors tailored to the project needs.
• Ensure team compliance with project-specific training matrix.
• Supervise preparation, conduct and reporting of site selection, site initiation, routine monitoring and closeout visits.
• Review site visit reports and ensures monitoring and reporting standards are met.
• Oversee investigator and site payments.
• Supervise project team preparation for study audits/ inspections and resolution of audit/ inspection findings.
• Might be involved in regional project oversight for APAC.

PSI CRO is looking for an experienced project finance professional in the Clinical Research industry, who will be responsible for creating, managing, negotiating, and analyzing clinical project budgets, as well as providing support with bids and contract management activities within the company.

Responsibilities:

• Development of study budget (preparation of budgets for bids and change of order budgets for on-going projects)
• Management of study budget throughout the clinical project duration (setup and maintenance of project finance information in PSI internal systems, preparation of accrual reports, request for invoices)
• Development of Sponsor Contract (preparation of sponsor agreements and change orders, development of payment schedules)
• Timesheet System Management (setup and maintenance of project-specific timesheets in PSI’s internal system, management of reconciliation of actual vs budget costs on a regular basis)