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Clinical Data Manager

Quanticate

Hyderabad, Chennai

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2 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 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. Scope of Responsibilities: Liaise with clinical, medical affairs, and regulatory teams for accurate safety data management. Coordinate with CROs and licensing partners to fulfil pharmacovigilance obligations. Prepare high-quality clinical and regulatory documents aligned to CTD submission standards. Participate in regulatory inspections, health authority meetings, and internal audits. Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Maintain up-to-date knowledge of ICH E2A-E2F, GCP, and pharmacovigilance regulations. Contribute to risk management plans, SOPs, and signal detection and evaluation processes. Support collection and review of adverse event safety data from clinical and post-market sources. Competencies and Qualifications: Detail-oriented mindset with the ability to synthesise and present complex information clearly. Ability to work both independently and in a team-oriented, collaborative environment. Proficiency in relevant software and digital tools specific to the functional area. Bachelor's degree in a relevant discipline; master's degree or professional certification is preferred. Strong interpersonal and stakeholder management skills with a client-service orientation. Exceptional organisational skills with the ability to handle multiple concurrent responsibilities. 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.