Clinical Data Manager
QuartesianClinicalResearchPvt
Bangalore, Mumbai
·2 w
·Full time
·Healthcare
$5,00,000 Per Year
$18,00,000 Per Year
Position: Clinical Data Manager We invite a proactive and capable Clinical Data Manager to lead and execute within a collaborative, agile environment. The incumbent will operate in a structured yet agile environment that prioritises quality and professional growth. Responsibilities Include: Maintain up-to-date knowledge of ICH E2A-E2F, GCP, and pharmacovigilance regulations. Conduct structured literature reviews and contribute to scientific summaries and labelling. Ensure audit-readiness of safety documentation in line with GxP and regulatory expectations. Coordinate with CROs and licensing partners to fulfil pharmacovigilance obligations. Support collection and review of adverse event safety data from clinical and post-market sources. Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. Participate in regulatory inspections, health authority meetings, and internal audits. Prepare high-quality clinical and regulatory documents aligned to CTD submission standards. Skills and Qualifications: Strong communication, presentation, and interpersonal skills across all organisational levels. A structured, results-driven approach with the ability to meet defined milestones consistently. Hands-on experience with tools, software, and platforms standard to the profession. 26 years of relevant industry experience with evidence of increasing responsibility. Bachelor's or master's degree in a related discipline with strong academic and professional credentials. Familiarity with regulatory, compliance, or quality frameworks applicable to the industry. 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.