Position: Clinical Data Manager A compelling career opportunity exists for a skilled Clinical Data Manager to drive meaningful impact. The organisation fosters a culture of continuous learning, development, and shared organisational accountability. Core Responsibilities: Participate in regulatory inspections, health authority meetings, and internal audits. Coordinate with CROs and licensing partners to fulfil pharmacovigilance obligations. Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. Support collection and review of adverse event safety data from clinical and post-market sources. Conduct structured literature reviews and contribute to scientific summaries and labelling. Liaise with clinical, medical affairs, and regulatory teams for accurate safety data management. Contribute to risk management plans, SOPs, and signal detection and evaluation processes. Prepare high-quality clinical and regulatory documents aligned to CTD submission standards. Minimum Qualifications: Collaborative, proactive, and able to operate effectively with minimal supervision. Superior writing and communication skills with experience preparing executive-level documents. Strong project management capabilities with experience in agile or structured methodologies. Expertise in applying quantitative and qualitative methods to support evidence-based decisions. Excellent attention to detail and commitment to producing accurate, high-quality deliverables. Relevant undergraduate or postgraduate degree aligned with the role's core responsibilities. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. Successful candidates will receive access to ongoing professional development and industry-leading resources.