In this role you will streamline activities of project teams and ensure consistency of Clinical Operations processes across regions. 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.
- MPharm, RN or university/college degree in Life Sciences or an equivalent combination of education, training and experience.
- 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.
- Proficiency in MS Office applications, including MS Project.
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