Position: Clinical Data Manager Our organisation invites applications from accomplished professionals for the role of Clinical Data Manager. This role sits within a fast-paced, innovation-driven organisation that values integrity and continuous improvement. Main Accountabilities: Review source data and ensure completeness, accuracy, and regulatory compliance. Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. Conduct benefit-risk assessments and contribute to clinical development strategy discussions. Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. Provide clinical site training on data collection standards and regulatory requirements. Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Develop SOPs, work instructions, and training materials for clinical operations teams. Manage medical coding using MedDRA and WHO Drug Dictionary for clinical trial data. Essential Skills and Experience: Knowledge of applicable regulatory frameworks, industry standards, and compliance requirements. Collaborative, proactive, and able to operate effectively with minimal supervision. Strong project management capabilities with experience in agile or structured methodologies. Expertise in applying quantitative and qualitative methods to support evidence-based decisions. Superior writing and communication skills with experience preparing executive-level documents. Relevant undergraduate or postgraduate degree aligned with the role's core responsibilities. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. The organisation provides a comprehensive benefits package and excellent career advancement opportunities for the right candidate.