Position: Clinical Research Manager-Breast Medicine Our firm seeks a competent and professional Clinical Research Manager-Breast Medicine for a critical role in a high-performance environment. This position offers the opportunity to work with a diverse, cross-functional team in a results-oriented culture. Role Responsibilities: Develop SOPs, work instructions, and training materials for clinical operations teams. Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. Track milestones and coordinate with sites, CROs, and sponsors for on-time delivery. Manage medical coding using MedDRA and WHO Drug Dictionary for clinical trial data. Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Plan, monitor, and close clinical trials in compliance with GCP and ICH guidelines. Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. Maintain trial master files and ensure ongoing audit-readiness and regulatory compliance. Education and Experience Requirements: Minimum 35 years of progressive professional experience in a comparable role. Demonstrated proficiency with industry-standard tools, platforms, and methodologies. Experience collaborating within cross-functional teams and matrix organisational structures. Excellent verbal and written communication skills; fluency in English is essential. Proven ability to manage competing priorities in a deadline-driven, dynamic environment. High degree of professionalism, integrity, and alignment with organisational values. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. Candidates who meet the above requirements are encouraged to submit their detailed CV at the earliest opportunity.