Senior Principal Investigator For a CRO Company, Hyderabad

We are seeking a highly experienced and motivated Senior Principal Investigator (PI) to lead and oversee clinical trials in accordance with regulatory standards and Good Clinical Practice (GCP) for our client a reputable CRO company based out of Hyderabad. The ideal candidate will be responsible for the scientific, ethical, and operational oversight of clinical studies, ensuring participant safety, protocol compliance, and data integrity. This role requires strong leadership, deep clinical expertise, and experience managing multiple clinical research programs within a CRO or research institution.

Key Responsibilities:

• Serve as the Principal Investigator for clinical trials.
• Ensure clinical trials are conducted in compliance with ICH-GCP, regulatory guidelines, and institutional policies.
• Provide medical oversight for study participants and ensure patient safety throughout the trial lifecycle.
• Lead protocol development, feasibility assessments, and study design discussions with sponsors.
• Supervise and mentor Sub-Investigators, Clinical Research Coordinators, and study staff.
• Review and approve study-related documents including protocols, informed consent forms, case report forms, and safety reports.
• Oversee patient recruitment, screening, enrollment, and follow-up activities.
• Ensure timely reporting of adverse events (AEs), serious adverse events (SAEs), and safety signals.
• Collaborate with sponsors, CRO teams, ethics committees, and regulatory authorities.
• Participate in site audits, sponsor visits, and regulatory inspections.
• Maintain accurate and complete study documentation and ensure data integrity.
• Contribute to clinical research publications, presentations, and scientific discussions where applicable.

Required Qualifications:

• MBBS with MD in a relevant clinical specialty.
• Minimum 15+ years of clinical experience, with significant exposure to clinical research and trials.
• Proven experience as a Principal Investigator or Lead Investigator in industry-sponsored clinical trials.
• Strong understanding of ICH-GCP guidelines, regulatory requirements, and ethics committee processes.
• Experience working with CROs, pharmaceutical companies, or research institutions.

Key Skills:

• Clinical trial leadership and oversight
• Regulatory compliance and GCP expertise
• Patient safety management
• Clinical protocol review and implementation
• Stakeholder and sponsor communication
• Team leadership and mentoring
• Data quality and documentation oversight

Preferred Qualifications:

• MBBS,MD
• Prior experience in multi-center or global clinical trials.
• Publications in peer-reviewed journals.
• Experience interacting with regulatory authorities and ethics committees.