Clinical Data Manager

Experience: 5+ yrs Work Mode: Work from Office Work Location: Bangalore LOOKING FOR IMMEDIATE JOINERS ONLY Job Description - Clinical Data Manager : OVERVIEW The Clinical Data Manager (CDM) is an independent role responsible for supporting the study team and developing comprehensive study documentation, designing database specifications, and overseeing validation, maintenance/data cleaning, and closeout activities for clinical trial databases. The CDM is recognized as the platform expert, leveraging cutting-edge tools and technologies to provide continuous data insights and ensure the timely delivery of high-quality results for Sponsors. The CDM has a strong foundation in clinical data management, combined with the agility to adapt as processes evolve towards the integration of clinical data science. KEY TASKS & RESPONSIBILITIES - Define project specifications for Data Management services, including Protocol Conversion, Database Build, CRF Design and Data Review and Data Reconciliation tools. - Understand external data collection, its integration into the clinical trial, and the management and reconciliation processes required to ensure its accuracy and relevance. - Execute data cleaning strategies to accelerate the time to achieve subject data cleanliness and ensure high-quality, timely deliverables. - Perform holistic data review and trending analysis via reporting and elluminate® analytics to proactively identify issue, risks and develop mitigation strategies. - Utilize artificial intelligence (AI) and machine learning (ML) for anomaly and outlier detection to enhance the efficiency and quality of trial data. - Monitor and interpret key performance indicators (KPIs), metrics, dashboards, Clinical Trial Operational Analytics (CTOA), and reports to provide actionable recommendations to study lead(s)/project manager. - Perform Query Management - Define specifications and collaborate with technical team on configuration of centralized data management platform, elluminate® Data Central for data cleaning strategy and oversight activities. - Prepare and maintain data management documentation (e.G., DMP, CCGs, Help Text, DVS) and update throughout trial lifecycle. - Review and ensure the quality control of team-developed deliverables, covering eCRFs, study documents, program/report specifications, outputs, and elluminate® Data Central with analytics modules. Actively evaluate and contribute to enhance processes to increase efficiency and effectiveness. - Collaborate and work as a team to ensure the deliverables are completed on time with high quality. - Ensure compliance with industry quality standards, regulations, guidelines, and procedures. - Other duties as assigned. CANDIDATE’S PROFILE: Education & Experience - 5+ years’ experience in Clinical Data Management preferred. - Bachelor’s degree in a health-related field or equivalent experience preferred. - CCDM Certification preferred. Professional Skills - Strong project management experience and project team leadership skills including work planning, work delegation and solving complex problems. - Strong analytical and strategic thinking skills - Detail oriented, ability to multitask with strong prioritization, planning and organization skills. - Excellent collaborative skills - Demonstrated command of the English language with proficiency in both verbal and written communication Technical Skills - Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel - Knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology - Proficient with EDC and Clinical Data Management Systems - Experience with Cloud SaaS platforms (preferred)Experience with data reporting tools such as Qlik, JReview, Spotfire preferred. - Experience with RBQM methodology preferred. - Exposure to CDISC guidelines and standards