Mbbs Doctor

Elite Biopharma; Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Elite Biopharma is seeking an experienced Clinical Trials Lead to oversee and drive multicenter studies in strict adherence to ICH-GCP guidelines. The role focuses on protecting participant safety, managing end-to-end trial activities, and ensuring regulatory compliance across sponsors and ethics committees.

The ideal candidate demonstrates strong leadership, excellent documentation, and the ability to coordinate cross-functional teams while maintaining high quality and ethical standards in

Qualifications

• Experience with ICH-GCP guidelines and regulatory requirements.
• Strong ability to manage complex clinical studies while ensuring participant safety.
• Excellent documentation, analytical, and problem-solving skills.
• Proven leadership and stakeholder coordination in multi-site trials.

Responsibilities

• Lead and oversee clinical trials in accordance with approved protocols and ICH-GCP guidelines.
• Ensure rights, safety, dignity, and well-being of participants throughout the study.
• Oversee screening, eligibility, enrolment, medical evaluations, and follow-up.
• Ensure informed consent is obtained and documented appropriately before procedures.
• Provide medical oversight for adverse events and safety concerns.
• Ensure timely safety reporting to sponsors and regulatory authorities.
• Supervise study team members and delegate responsibilities.
• Maintain accurate source documents and trial records.
• Ensure compliance with SOPs and regulations.
• Liaise with sponsors, CROs, Ethics Committees, and authorities.
• Lead study initiation, monitoring visits, audits, and inspections.
• Identify protocol deviations and CAPA actions.
• Maintain investigator site files and training records.
• Contribute to feasibility, recruitment planning, and quality improvement.

Skills

Clinical trial oversight

Leadership

Regulatory compliance

Documentation quality

Job description

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.