20 Aug
|
Apotex
|
Bengaluru
Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, creative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.
Responsible for execution of the study and system related activities as per the established Standard Operating Procedures (SOP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP) best practices and regulatory requirements.
Conducts duties following established Apotex Research Pvt. Bioequivalence Center’s Standard Operating Procedures and in a manner consistent with the appropriate regulatory guidelines, GCP requirements and Safe Work Procedures.
Handling and execution of studies as per protocol,
SOP and applicable regulatory requirements in a timely manner as per the agreed timelines in coordination with the study coordinator and Investigator.
Planning and coordinating for the Protocol Training, Study Check-in activities with the study coordinator.
Ensure sufficient clinical supplies were in place for the study.
Preparation and compilation of TMF, Raw data, study schedule, Stations as required for the study.
Performs and ensures clinic staff activities during the study was ongoing in compliance with protocol and SOPs. Review the generated data periodically while the study was ongoing for completeness and accuracy in compliance to protocol and SOPs.
Performs dosing related activities (such as dosing, dosing supervision, Test Article verification and mouth check).
Collection and online review of the collected data during the study such as Subject ICD, Screening Consent Forms and Sample Processing Logs etc.
Pr
📌 Research Associate (Bengaluru)
🏢 Apotex
📍 Bengaluru