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) and regulatory requirements.
Job Responsibilities
Conducts duties following established Apotex Research Pvt. Ltd., Bioequivalence Center’s Standard Operating Procedures and in a manner consistent with the appropriate regulatory guidelines, GCP requirements and Safe Work Procedures.
Entry of the study data in the required formats / data base for report table preparation and CDISC datasets preparation.
Performs the collection, recording, retrieval of information, verify the accuracy of the information, manage data storage and retrieval systems.
Review of report tables.
Performs the activities related to requisition, receiving and accountability of the forms for the study.
Ensure readiness of the department to face regulatory audit by following good documentation practices, GCP & relevant SOPs.
Organizing files and collecting clinical data to be entered into the databases or in required formats.
Assists in reconciliation of the study data.
Coordinates / communicates internal and / or with cross functional departments for study relevant activities.
Perform study activities as per the study specific protocol requirements and other duties as assigned by the Clinical Operations Management/delegate as training and experience allow.
Responsible for handling (receiving, Issuing, Storage etc.,) of Clinical Study Materials in stores.
Performs work in accordance with all established regulatory, compliance and safety requirements.
Works in a safe manner collaborating as a team member to achieve all outcomes.
Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
All other relevant duties as assigned.
Job Requirements
Education
B.Pharm / Pharm D / B.Sc. in Life Science related filed.
Knowledge, Skills and Abilities
Good skills in MS Office.
Good in Communication skills.
Flexible to work
Experience
0-2 years in Clinical Reasearch Associate
About Apotex Inc.
Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.
