PSI CRO AG logo
PSI CRO AG

The global CRO where clinical trials run on time.

Clinical Regional Project Lead

GeneralGeneralFull TimeRemoteSeniorTeam 1,001-5,000Since 1996H1B No SponsorCompany SiteLinkedIn

Location

Malaysia

Posted

10 hours ago

Salary

0

Seniority

Senior

Bachelor Degree4 yrs expEnglish

Job Description

Clinical Regional Project Lead

PSI CRO AG

• Streamline activities of project teams and ensure consistency of Clinical Operations processes across Asia Pacific region. • Ensure meeting study milestones by project teams on a country level. • Report study progress to clients and global stakeholders. • 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.

Job Requirements

  • 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.

Benefits

  • Professional development opportunities

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