Clinical Data Management

The role in this Pharmaceutical & Life Sciences full-time job based in Chennai, Tamil Nadu, requires you to oversee the collection, validation, and processing of clinical trial data. You will be responsible for developing and implementing data management procedures for clinical trials, supporting the review of medical coding, and ensuring compliance with applicable regulations, protocols, and standard operating procedures in India. Your role will involve maintaining the highest data quality standards throughout the data lifecycle, from data collection to database lock. It is essential to stay updated on industry best practices, technological advancements, and regulatory requirements related to clinical data management. The preferred candidate for this position should hold certification in clinical data management (like CCDM) and possess knowledge of CRF design, MS Project, and analytical capabilities. Familiarity with CDISC standards and data interchange formats such as SDTM and ADaM is beneficial. Basic knowledge of regulatory guidelines like FDA/CFR, ICH/GCP, understanding of data privacy and protection regulations (e.g., GDPR), and effective communication and interpersonal skills are essential to collaborate effectively with other teams. This role offers the opportunity to contribute to the advancement of clinical data management practices and maintain high standards of data quality in compliance with regulations and protocols.,