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Clinical Data Manager

CadilaHealthcareLtd

Delhi, Mumbai

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3 w

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Full time

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Healthcare

Minimum

$5,00,000 Per Year

Maximum

$18,00,000 Per Year

Position: Clinical Data Manager We are on the lookout for a well-rounded Clinical Data Manager to contribute to our operational and strategic priorities. The organisation fosters a culture of continuous learning, development, and shared organisational accountability. Core Responsibilities: Contribute to risk management plans, SOPs, and signal detection and evaluation processes. Conduct structured literature reviews and contribute to scientific summaries and labelling. 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. Ensure audit-readiness of safety documentation in line with GxP and regulatory expectations. Support collection and review of adverse event safety data from clinical and post-market sources. Participate in regulatory inspections, health authority meetings, and internal audits. Coordinate with CROs and licensing partners to fulfil pharmacovigilance obligations. Minimum Qualifications: Relevant undergraduate or postgraduate degree aligned with the role's core responsibilities. Superior writing and communication skills with experience preparing executive-level documents. Excellent attention to detail and commitment to producing accurate, high-quality deliverables. Collaborative, proactive, and able to operate effectively with minimal supervision. Knowledge of applicable regulatory frameworks, industry standards, and compliance requirements. Expertise in applying quantitative and qualitative methods to support evidence-based decisions. 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.