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), responsible 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.
Solid 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, qualified integrity, and confidentiality.

Salary

📌 Mbbs Doctor Hyderabad (India)
🏢 Elite Biopharma
📍 India