Torrent Pharmaceuticals Ltd. a global pharmaceutical company whose headquarters is in Ahmedabad is hiring for the position of AGM/ Manager (Principal Investigator) for the location Gandhinagar, Gujarat.
Requirements
Qualification & Experience
MD with minimum 8 yrs / MBBS with 12 years.
Job Responsibilities
- To plan for BA/ BE / Phase I studies and related resources.
- To ensure compliance with Good Clinical Practice and study protocol during the course of clinical study.
- To collaborate with the Institutional Ethics Committee (IEC) and provide updates on the study-related information to the IEC.
- To resolve the study-related queries raised by the Ethics Committee & regulatory bodies.
- To approve the study-related documents (i.e. Protocol, ICF, CRF) prepared by subordinates.
- To ensure the GLP compliance of the Biochemical and Clinical Pathology laboratory operations.
- To ensure volunteer safety and report adverse events (if any).
- To maintain the investigational product accountability at the site.
- To coordinate regulatory and ethical issues related to clinical study.
- To review and approve clinical study reports and related SOPs.
- To maintain the records of the study at the site.
- To ensure the appropriateness of the informed consent process and confidentiality of the volunteers.
- To ensure the accuracy, completeness, legibility, and timeliness of the data reported to concerned authorities.
- To manage the Regulatory and Quality Audits (internal & external).
Location
Gandhinagar, Gujarat
Interested candidates can share their CVs at anupathale@torrentpharma.com.
