Clinical Data Manager

Description : 5 to 7 yrs

Work Mode : Hybrid (3 days in a week) / Onsite (for initial one or two months for training purpose from date of joining)

Work Location : White Field , Bangalore

Interview Process : 1st round - Virtual Tech Interview & 2nd Round ( Face to Face Technical interview @ ACL digital office {Whitefield / Bannerghatta })

CDM Mandatory Skills : End to end activities (Start, Conduct & Close), ECRF, Protocol Review, UAT testing, Data Cleaning, Discrepancy Management, Reconciliation

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 :

CANDIDATES PROFILE :

Education & Experience :

Professional Skills :

Technical Skills :

(ref : hirist.tech)