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 e CRFs, 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. 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 Saa S platforms (preferred)Experience with data reporting tools such as Qlik, JReview, Spotfire preferred. · Experience with RBQM methodology preferred. · Exposure to CDISC guidelines and standards.