Clinical Data Management - Principal Trial Manager
Icon plc
Mumbai, Hyderabad
·3 w
·Full time
·Healthcare
$5,00,000 Per Year
$18,00,000 Per Year
Position: Clinical Data Management - Principal Trial Manager We invite a proactive and capable Clinical Data Management - Principal Trial Manager to lead and execute within a collaborative, agile environment. The organisation fosters a culture of continuous learning, development, and shared organisational accountability. Duties and Accountabilities: 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. Ensure all cases are coded and processed per MedDRA and applicable global standards. Conduct structured literature reviews and contribute to scientific summaries and labelling. Liaise with clinical, medical affairs, and regulatory teams for accurate safety data management. Support collection and review of adverse event safety data from clinical and post-market sources. Coordinate with CROs and licensing partners to fulfil pharmacovigilance obligations. Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. Key Skills and Qualifications: Advanced competency in analytical tools, reporting platforms, and role-specific technology. Commitment to professional ethics, confidentiality, and the highest standards of conduct. Leadership experience with a track record of guiding teams, projects, or cross-functional initiatives. Recognised qualification in the relevant professional field at the undergraduate or graduate level. Sound understanding of organisational dynamics and stakeholder management in complex environments. Effective presentation skills with the ability to communicate complex ideas with clarity. 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.