Clinical Data Management

Role Overview: As a member of the Pharmaceutical & Life Sciences team, your role will involve overseeing the collection, validation, and processing of clinical trial data. You will be responsible for developing and implementing data management procedures for clinical trials, as well as supporting and facilitating the review of medical coding for validity and completeness. Your key focus will be on ensuring compliance with applicable regulations, protocols, and standard operating procedures in India. It will be essential for you to maintain the highest data quality standards throughout the data lifecycle, from data collection to database lock. Additionally, staying updated on industry best practices, technological advancements, and regulatory requirements related to clinical data management will be a crucial part of your responsibilities. Key Responsibilities: - Oversee the collection, validation, and processing of clinical trial data. - Develop and implement data management procedures for clinical trials. - Support and facilitate the review of medical coding for validity and completeness. - Ensure compliance with applicable regulations, protocols, and standard operating procedures in India. - Maintain the highest data quality standards throughout the data lifecycle. - Stay updated on industry best practices, technological advancements, and regulatory requirements related to clinical data management. Qualification Required: - Certification in clinical data management (like CCDM). - Knowledge of CRF design, MS Project, and analytical capabilities. - Knowledge of CDISC standards and data interchange formats (e.g., SDTM, ADaM). - Familiarity with clinical trial design and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP). - Understanding of data privacy and protection regulations (e.g., GDPR). - Effective communication and interpersonal skills to collaborate with other teams.,