Assistant Manager - Clinical Operations

Job Summary

Responsible for management and execution of clinical studies as per the established Standard Operating Procedures (SOP), Good Clinical Practices (GCP), applicable Good Laboratory Practices (GLP) best practices 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.
• Responsible for all activities related to the protocol management including preparation, review of protocol, coordination of the Informed consent translations for IEC meetings and protocol status reports.
• Activates approved Protocol for study use and distribution after IEC approval and applicable sign off.
• Ensures all regulatory documents are completed for the applicable jurisdictions.
• Preparation/review of screening and study related forms for data collection.
• Responsible for tracking and management of Deviation Reports and file notes/Memo to Files generated within the department.
• Reviews the completed Screening documentation for inclusion and exclusion criteria dictated by project-specific protocols.
• Conducts protocol training with all staff involved in the screening/study activities.
• Ensures adequate quantity of materials and supplies are available before initiation of the study.
• Oversees the test article management process including accountability, packaging, and inventory of test articles.
• Directly supervises and takes delegated responsibility for the conduct and safety of volunteers participating in clinical studies, for adherence to protocols and regulatory requirements.
• Supervises/oversees clinic staff activities for compliance with protocol and SOPs.
• Collects, reviews and summarizes clinical data and compiles the clinical portion of the report.
• Oversees the sample transfer process.
• Ensures projects meet the projected timelines and communicates projects updates.
• Involves in the creation, development and revision of the Bioequivalence Center’s Clinical Operations Department Standard Operating Procedures.
• Assist in providing the responses to the regulatory deficiencies as assigned by the management.
• Executes other duties as may be assigned by the Clinical Operations Management/delegate as training and experience allow.
• 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 duties as assigned.

Job Requirements

• Education
  • M.Sc., /M. Pharm., /B. Pharm.

• Knowledge, Skills and Abilities
  • Good Communication skills.
  • Flexible to work

• Experience
  • Minimum of 10 years experience clinical operations
  • Experience in GCP/ GLP along with strong understanding of compliance in these areas