Prestige BioPharma limited – Clinical Operation Intern

Prestige BioPharma (PBP) is a Singapore based biopharmaceutical company focusing on development of biosimilars and new antibody therapeutics. PBP has strong presence and networks in Asia Pacific region and actively penetrating into the global pharmaceutical market. The successful completion of phase I clinical trial on its first biosimilar HD201 (Trastuzumab) in EU, 2014, has placed PBP amongst the top-tier biosimilar developers.

The Clinical Operations Intern will support the Clinical Operations team in the conduct and oversight of assigned clinical studies. 

Key responsibilities will include:

• Support day-to-day Clinical Operations activities for assigned clinical studies under the guidance of the study team.
• Assist with updating and maintaining clinical study trackers, including tracking of study timelines, site activities, documentation, and other study-related information.
• Support the preparation, handling, distribution, filing, and archiving of clinical trial documentation in accordance with applicable SOPs and Good Clinical Practice (GCP) requirements.
• Assist with periodic review of study files and documentation for completeness, accuracy, and appropriate filing.
• Support the review and tracking of essential clinical trial documents.
• Assist with consolidation, organization, and review of study-related data and information.
• Support Clinical Operations process improvement and administrative activities.
• Prepare or assist with PowerPoint presentations, study trackers, posters, and other study-related materials as required.
• Provide general administrative and operational support to the Clinical Operations team.
• Perform other ad-hoc duties as assigned.