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Clinical Data Manager

Clinical Data Manager

ClinovoIndia
30+ days ago
Job description

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.

    • 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.
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