Clinical Data Management

As a Clinical Data Manager in the pharmaceutical and life sciences industry, your role involves overseeing the collection, validation, and processing of clinical trial data. You will be responsible for developing and implementing data management procedures, ensuring compliance with regulations and protocols, and maintaining the highest data quality standards throughout the data lifecycle. Your key responsibilities include: - Overseeing the collection, validation, and processing of clinical trial data. - Developing and implementing data management procedures for clinical trials. - Supporting and facilitating the review of medical coding for validity and completeness. - Ensuring compliance with applicable regulations, protocols, and standard operating procedures in India. - Maintaining the highest data quality standards from data collection to database lock. - Staying updated on industry best practices, technological advancements, and regulatory requirements related to clinical data management. Preferred qualifications for this role include: - Certification in clinical data management (e.g., CCDM). - Knowledge of CRF design, MS Project, and analytical capabilities. - Familiarity with CDISC standards and data interchange formats such as SDTM and ADaM. - Understanding of clinical trial design and basic knowledge of regulatory guidelines like FDA/CFR and ICH/GCP. - Awareness of data privacy and protection regulations like GDPR. - Effective communication and interpersonal skills to collaborate with other teams. This role offers you the opportunity to work in a dynamic environment where you can contribute to the advancement of clinical data management practices in the pharmaceutical and life sciences sector.,