APAC Regional Project Lead — Clinical Operations

Psi CRO; Sydney; Vor Ort; AUD 120.000 - 150.000; Vollzeit

Zusammenfassung

Psi CRO in Sydney is seeking a Project Manager to streamline Clinical Operations activities across the Asia Pacific region. You will ensure study milestones are met, report progress to clients and global stakeholders, and act as PM contact for project teams.

Responsibilities include developing planning documents, overseeing site initiation, monitoring, and audits, coordinating tracking systems, and leading cross-functional teams with strong English communication.

Qualifikationen

• MPharm, RN or Life Sciences degree or equivalent.
• Minimum 4 years’ site monitoring experience and at least 2 years’ experience as Lead Monitor, preferably in regional capacity.
• Experience supervising clinical project activities and leading clinical project teams.
• Experience in oncology, gastroenterology, infectious diseases, autoimmune diseases, or any rare disease indication is preferable.
• Communication, presentation, and customer-service skills.
• Team building, leadership and organizational skills.
• Full working proficiency in English.

Aufgaben

• 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 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.

Kenntnisse

Project leadership

Communication

Presentation skills

Customer service

Team building

Organizational skills

Ausbildung

MPharm, RN or Life Sciences degree

Tools

MS Office

MS Project

Jobbeschreibung

Psi CRO in Sydney is seeking a Project Manager to streamline Clinical Operations activities across the Asia Pacific region. You will ensure study milestones are met, report progress to clients and global stakeholders, and act as PM contact for project teams.

Responsibilities include developing planning documents, overseeing site initiation, monitoring, and audits, coordinating tracking systems, and leading cross-functional teams with strong English communication.