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Clinical Data Manager

Ephicacy

Bangalore, Delhi

·

3 w

·

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 looking for a strategic and detail-oriented Clinical Data Manager to deliver excellence across key functions. The incumbent will operate in a structured yet agile environment that prioritises quality and professional growth. Key Responsibilities: Ensure audit-readiness of safety documentation in line with GxP and regulatory expectations. Coordinate with CROs and licensing partners to fulfil pharmacovigilance obligations. 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. Support collection and review of adverse event safety data from clinical and post-market sources. 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. Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. Qualifications and Requirements: A bachelor's degree or higher in a relevant field; postgraduate qualifications are an added advantage. 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. Proven ability to manage competing priorities in a deadline-driven, dynamic environment. Experience collaborating within cross-functional teams and matrix organisational structures. 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.