Clinical Data Manager

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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