$5,00,000 Per Year
$18,00,000 Per Year
Position: Clinical Data Manager A compelling career opportunity exists for a skilled Clinical Data Manager to drive meaningful impact. The incumbent will operate in a structured yet agile environment that prioritises quality and professional growth. Duties and Accountabilities: Maintain up-to-date knowledge of ICH E2A-E2F, GCP, and pharmacovigilance regulations. Prepare high-quality clinical and regulatory documents aligned to CTD submission standards. Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. Coordinate with CROs and licensing partners to fulfil pharmacovigilance obligations. Participate in regulatory inspections, health authority meetings, and internal audits. Contribute to risk management plans, SOPs, and signal detection and evaluation processes. Conduct structured literature reviews and contribute to scientific summaries and labelling. Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Key Skills and Qualifications: Effective presentation skills with the ability to communicate complex ideas with clarity. Recognised qualification in the relevant professional field at the undergraduate or graduate level. Advanced competency in analytical tools, reporting platforms, and role-specific technology. Critical and strategic thinking skills with the ability to translate insights into clear actions. Leadership experience with a track record of guiding teams, projects, or cross-functional initiatives. Sound understanding of organisational dynamics and stakeholder management in complex environments. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. This is an outstanding opportunity for a motivated professional to advance their career within a reputable organisation.