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