Position: Clinical Data Manager We are looking for a strategic and detail-oriented Clinical Data Manager to deliver excellence across key functions. The organisation fosters a culture of continuous learning, development, and shared organisational accountability. Key Responsibilities: Ensure audit-readiness of safety documentation in line with GxP and regulatory expectations. Participate in regulatory inspections, health authority meetings, and internal audits. Ensure all cases are coded and processed per MedDRA and applicable global standards. Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. Coordinate with CROs and licensing partners to fulfil pharmacovigilance obligations. Prepare high-quality clinical and regulatory documents aligned to CTD submission standards. 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. Qualifications and Requirements: Excellent verbal and written communication skills; fluency in English is essential. High degree of professionalism, integrity, and alignment with organisational values. Demonstrated proficiency with industry-standard tools, platforms, and methodologies. Minimum 35 years of progressive professional experience in a comparable role. Strong analytical and problem-solving skills with the ability to navigate complex challenges. Experience collaborating within cross-functional teams and matrix organisational structures. 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.