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Clinical Data Manager

PPD

Mumbai, Bangalore

·

2 w

·

Full time

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Healthcare

Minimum

$5,00,000 Per Year

Maximum

$18,00,000 Per Year

Position: Clinical Data Manager An exceptional opportunity has arisen for a talented Clinical Data Manager to contribute to our mission. The candidate will join a globally connected team that prizes diverse perspectives and operational excellence. Duties and Accountabilities: Ensure all cases are coded and processed per MedDRA and applicable global 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. 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. Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Coordinate with CROs and licensing partners to fulfil pharmacovigilance obligations. Participate in regulatory inspections, health authority meetings, and internal audits. Key Skills and Qualifications: Commitment to professional ethics, confidentiality, and the highest standards of conduct. Recognised qualification in the relevant professional field at the undergraduate or graduate level. Advanced competency in analytical tools, reporting platforms, and role-specific technology. Sound understanding of organisational dynamics and stakeholder management in complex environments. Leadership experience with a track record of guiding teams, projects, or cross-functional initiatives. Critical and strategic thinking skills with the ability to translate insights into clear actions. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. This position represents a unique platform for a high-calibre professional to make a lasting contribution.