Clinical Research Associate / Sr. CRA - Oncology
Flipkart
Hyderabad, Mumbai
·2 w
·Full time
·Healthcare
$4,00,000 Per Year
$12,00,000 Per Year
Position: Clinical Research Associate / Sr. CRA - Oncology A distinguished opportunity awaits a seasoned Clinical Research Associate / Sr. CRA - Oncology within our progressive, innovation-led organisation. This position is embedded within a high-functioning team that prizes collaboration, innovation, and quality. Principal Responsibilities: Develop SOPs, work instructions, and training materials for clinical operations teams. Track milestones and coordinate with sites, CROs, and sponsors for on-time delivery. Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. Review source data and ensure completeness, accuracy, and regulatory compliance. Manage medical coding using MedDRA and WHO Drug Dictionary for clinical trial data. Provide clinical site training on data collection standards and regulatory requirements. Conduct benefit-risk assessments and contribute to clinical development strategy discussions. Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. Candidate Requirements: Commitment to professional ethics, confidentiality, and the highest standards of conduct. Effective presentation skills with the ability to communicate complex ideas with clarity. Sound understanding of organisational dynamics and stakeholder management in complex environments. Advanced competency in analytical tools, reporting platforms, and role-specific technology. Critical and strategic thinking skills with the ability to translate insights into clear actions. Recognised qualification in the relevant professional field at the undergraduate or graduate level. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. Applications are reviewed on a rolling basis; suitably qualified individuals are encouraged to apply promptly.