Clinical Data Manager

Clinical Data Manager (CDM) Experience:

5+ Years Education:

Bachelor’s degree in Health/Clinical-related field or equivalent Certification:

CCDM preferred Role Summary Responsible for

end-to-end Clinical Data Management (CDM)

activities across study setup, conduct, and closeout, including database design/build, data cleaning, reconciliation, validation, reporting, and delivery of high-quality clinical trial data. Acts as a platform expert and supports the adoption of

clinical data science, AI/ML, and analytics . Key Responsibilities Manage end-to-end CDM activities:

Study Setup → Conduct → Database Lock/Closeout . Define specifications for

Protocol Conversion, Database Build, CRF Design, Data Review, and Data Reconciliation . Manage

external data integration, reconciliation, and data cleaning

activities. Develop and execute

data cleaning strategies, query management, data review, and trending analysis . Perform holistic data review using

reporting, elluminate® Analytics, dashboards, KPIs, CTOA, and metrics

to identify risks and drive mitigation. Leverage

AI/ML for anomaly and outlier detection

to improve data quality and efficiency. Define specifications and collaborate with technical teams on

elluminate® Data Central

configuration and data management workflows. Prepare and maintain CDM documentation including

DMP, CCGs, Help Text, and DVS

throughout the study lifecycle. Perform

QC/review of eCRFs, study documents, specifications, programs/reports, outputs, and elluminate® Data Central/Analytics modules . Ensure compliance with

ICH-GCP, 21 CFR Part 11, clinical trial methodology, applicable regulations, standards, and SOPs . Collaborate with study/project teams to ensure

timely, high-quality deliverables . Required Technical Skills 5+ years of hands-on Clinical Data Management experience . Strong experience with

EDC and Clinical Data Management Systems . End-to-end CDM lifecycle experience:

Setup, Start, Conduct, and Closeout . Experience with

Cloud/SaaS platforms

preferred. Experience with

Qlik, JReview, Spotfire , or similar data reporting/analytics tools preferred. Knowledge of

RBQM (Risk-Based Quality Management)

methodology preferred. Exposure to

CDISC standards and guidelines . Strong knowledge of

ICH-GCP, 21 CFR Part 11, and clinical trial processes . Proficiency in

MS Excel and MS Project . Professional Skills Strong

project management, team leadership, planning, delegation, and problem-solving

skills. Strong

analytical and strategic thinking . Excellent

communication, collaboration, prioritization, and organizational skills . Strong written and verbal

English communication . Preferred:

CCDM Certification.