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About the Role
This role focuses on streamlining project team activities and ensuring consistency of Clinical Operations processes across the Asia Pacific region. The position is responsible for meeting study milestones, reporting study progress to clients and global stakeholders, and potentially involved in regional project oversight for APAC.
Responsibilities
- 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.
Requirements
- Minimum 4 years’ site monitoring experience.
- 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.
- Full working proficiency in English.
- Proficiency in MS Office applications, including MS Project.
Skills
- Communication skills
- Presentation skills
- Customer-service skills
- Team building skills
- Leadership skills
- Organizational skills
Location
- Asia Pacific region
Work Type
- Full-time
Experience Level
- Minimum 4 years site monitoring experience
- Minimum 2 years Lead Monitor experience
Education Level
- MPharm
- RN
- University/college degree in Life Sciences
- Equivalent combination of education, training and experience
About the Company
- PSI is a leading Contract Research Organization (CRO) with over 25 years of experience in the pharmaceutical industry.
- PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries and continents.
- PSI is a stable and secure workplace with exceptionally high repeat and referral business rate and minimal staff turnover.
- More than 25% of our colleagues have been with us for over 10 years.
- PSI fosters an environment where a diverse range of colleagues feel welcomed and valued.
- PSI is committed to delivering high-quality, timely services across a broad spectrum of therapeutic indications.
- PSI invests in professional development and success.