Assistant Manager - Clinical Operations

Job Summary

Responsible for screening related activities and handling of study related data as in charge physician in compliance with standard operating procedures (SOPs) Good Clinical Practices (GCP) and applicable regulatory guidelines. Clinical research physician is also responsible for overall safety of study subjects.

Job Responsibilities

1. Conducts duties following established Apotex Research Pvt. Ltd., Bioequivalence Centre’s Standard Operating Procedures and in a manner consistent with the appropriate regulatory guidelines, GCP requirements and Safe Work Procedures.
2. Responsible for the screening:

• Performs physical examination, including Medical history, of the potential volunteers
• Provides medical counselling to volunteers with abnormal screening results
• Interviews potential volunteers, reviews laboratories reports, ECG and X-ray as required. Reviews subject eligibility to confirm with protocol requirements
• Reviews screening results and assesses volunteer suitability for entrance into studies
• Review of medical files, updation and release. Maintain accountability of eligible volunteers for a study.
• Provides medical counselling to volunteers with abnormal screening results

3. Actively participate in check-in related activities, perform compliance, and review volunteer eligibility to confirm with protocol requirements.
4. Confirms subject comprehension of study activities and ensures Informed consent is given prior to entry into study.
5. Oversees and assists in the administration of test articles
6. Ensure all study related activities are performed in compliance with the protocol.
7. Responsible for management of medical emergencies, familiar to use of on-site emergency medical equipment when deemed necessary
8. Other study related activities as in charge study physician, responsible Participates as responsible Clinician for selected studies. Assesses subjects’ adverse events and provides appropriate treatment and follow up
9. Assists in training of other study personnel when required.
10. Executes other duties as may be assigned /delegate as training and experience allow.
11. In consultation with principal investigator is responsible for withdrawal of study subject when found necessary for safety of the subject / protocol requirement.
12. Works and/or liaises with external medical services as required for appropriate adverse event follow-up in consultation with investigator.
13. Assists in the creation, development and revision of the Bioequivalence Centre’s Clinical Operations Department Standard Operating Procedures.
14. Supervises the activities of Nurses and Duty Medical Officers for rendering medical services to the subject at the Clinical Facility.
15. Works in a safe manner collaborating as a team member to achieve all outcomes.
16. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
17. 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.
18. All other relevant duties as assigned.

Job Requirements

• Education requirements: M.B.B.S.
  
  
• Knowledge, Skills and Abilities:
  • Good communication skills.
  • Flexible to work.
    
    
• Experience:
  • Minimum of 3 years of experience in clinical operations.
  • Experience in GCP/GLP along with strong understanding of compliance in these areas.