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, qualified integrity, and confidentiality.

Salary

📌 Mbbs Doctor (Hyderabad)
🏢 Elite Biopharma
📍 Hyderabad