Softpath Technologies

Description :Position : Clinical Data Manager (Life Science) Experience : 5 - 7 +YearsLocation : BangaloreJob Mode : WFOMandatory Skills (CDM) :- End-to-end activities (Start, Conduct & Close)- ECRF, Protocol Review, UAT Testing- Data Cleaning, Discrepancy Management, ReconciliationRole Overview :Clinical Data Manager (CDM) plays an independent and critical role in supporting study teams, developing study documentation, designing database specifications, and overseeing validation, data cleaning, and closeout activities for clinical trial databases. As a platform expert, the CDM leverages advanced tools and technologies to deliver continuous data insights and ensure the timely delivery of high-quality results for Sponsors. The role requires a strong foundation in clinical data management and adaptability to evolving processes integrating clinical data science.Key Responsibilities :- Define project specifications for Data Management services including Protocol Conversion, Database Build, CRF Design, Data Review, and Data Reconciliation tools.- Understand external data collection and its integration into clinical trials, ensuring accuracy and relevance.- Execute data cleaning strategies to achieve subject data cleanliness and ensure timely deliverables.- Perform holistic data review and trending analysis through reporting and elluminate analytics to identify issues and develop mitigation strategies.- Utilize AI and ML for anomaly and outlier detection to enhance trial data quality and efficiency.- Monitor and interpret KPIs, metrics, dashboards, and Clinical Trial Operational Analytics (CTOA) to provide actionable recommendations to study leads/project managers.- Perform Query Management.- Define specifications and collaborate with the technical team on configuring centralized data management platforms such as elluminate Data Central.- Prepare and maintain data management documentation (DMP, CCGs, Help Text, DVS) and update throughout the trial lifecycle.- Review and ensure quality control of deliverables including eCRFs, study documents, reports, outputs, and analytics modules.- Collaborate with the team to ensure on-time, high-quality deliverables.- Ensure compliance with industry quality standards, regulations, and procedures.- Perform other duties as assigned.Education & Experience :- Bachelors degree in a health-related field or equivalent experience (preferred).- 5+ years of experience in Clinical Data Management.- CCDM Certification (preferred).Professional Skills :- Strong project management and team leadership skills including work planning and problem-solving.- Strong analytical and strategic thinking abilities.- Excellent attention to detail, multitasking, prioritization, and organizational skills.- Excellent collaboration and communication skills (verbal & written).Technical Skills :- Proficiency in Microsoft Office (MS Project, MS Excel).- Knowledge of ICH/GCP guidelines, 21 CFR Part 11, and clinical trial methodology.- Proficiency with EDC and Clinical Data Management Systems.- Experience with Cloud SaaS platforms (preferred).- Familiarity with data reporting tools (Qlik, JReview, Spotfire preferred).- Experience with RBQM methodology (preferred).- Exposure to CDISC guidelines and standards. (ref:hirist.tech)