Mbbs Doctor

Role & responsibilities

• Lead and oversee clinical trials in accordance with approved protocols, ICH-GCP guidelines, and applicable regulatory requirements.
• Ensure the rights, safety, dignity, and well-being of clinical trial participants throughout the study.
• Oversee participant screening, eligibility assessments, enrolment, medical evaluations, and follow-up.
• Ensure that informed consent is obtained and documented appropriately before study-related procedures.
• Provide medical oversight for adverse events (AEs), serious adverse events (SAEs), and other safety concerns.
• Ensure timely safety reporting to sponsors, Ethics Committees, and regulatory authorities, as applicable.
• Supervise and oversee study team members and ensure appropriate delegation of study responsibilities.
• Ensure accuracy, completeness, and timely maintenance of source documents, case report forms, and essential trial records.
• Maintain compliance with study protocols, Ethics Committee approvals, SOPs, and applicable regulations.
• Liaise with sponsors, CROs, Ethics Committees, regulatory authorities, and other study stakeholders.
• Lead study initiation, monitoring visits, audits, regulatory inspections, and study close-out activities.
• Identify and manage protocol deviations, non-compliance, and corrective and preventive actions (CAPA).
• Ensure investigator site files, training records, and other essential documents are maintained and inspection-ready.
• Contribute to study feasibility, recruitment planning, resource management, and clinical research quality improvement.
• Ensure appropriate medical facilities, emergency procedures, and qualified personnel are available for the assigned study.

Preferred candidate profile

• Excellent clinical judgement and medical decision-making.
• Strong leadership, team management, and stakeholder coordination.
• In-depth knowledge of clinical research processes and regulatory compliance.
• Excellent documentation, analytical, and problem-solving skills.
• Ability to manage complex clinical studies while maintaining quality and participant safety.
• High standards of medical ethics, professional integrity, and confidentiality.

Salary