Job Description

You will liaise with both internal and external stakeholders as applicable on assigned responsibilities.

• Assist the project manager and project team with tracking of project progress, adherence to deliverables and timelines
• Assist with maintenance of the project timeline
• Assist in the preparation, handling, filing and archiving of clinical documentation and reports
• Perform periodic reviews of study files to assess documentation completeness and resolution of issue to support inspection readiness status
• Liaises with the CRO and vendors as applicable to track and monitor progress of activities and adherence to project scope and deliverables
• Support the project reporting with development of regular reports, newsletters and trackers
• Support project meetings including scheduling and managing meetings with agendas and minutes
• Provide general project administrative support

Required Knowledge, Skills, and Abilities

• BSc in life science or related field
• Basic knowledge of clinical research regulatory requirements i.e. GCP guidelines
• Computer skills including working knowledge of Microsoft Word, Excel, and PowerPoint
• Effective time management and organizational skills
• Excellent attention to detail
• Excellent written and verbal communication skills including English fluency
• Clinical trial experience working with either CRO or Sponsor
• Experience working in a multidisciplinary team