GHLCONSULT

www.ghlconsult.com

1 Job

6 Employees

About the Company

GHL Consult offers a unique all in one expertise related to recuitment, coaching, head-hunting, artistic and project management in some areas like pharma / biotech, luxury, advertising / design, IS/IT, Tourism & Transport among others... You may ask as well for our professional services on a local and international perspective.

Listed Jobs

Company Name: GHLCONSULT
Job Title: Clinical data manager senior F/H
Job Description: **Job Title:** Senior Clinical Data Manager **Role Summary** Oversee clinical data management in trial processes, ensuring compliance with study protocols, data integrity, and quality standards. **Expectations** - Minimum 5 years of clinical data management experience, preferably in adaptive trial designs. - Proficiency in SAS programming required, with expertise in EDC systems (Ennov Clinical preferred). **Key Responsibilities** - Design paper and electronic case report forms (eCRF) aligned with study protocols. - Coordinate data management activities across project teams and clinical data managers. - Extract and prepare data for statistical analysis. - Develop and validate consistency checks (edit checks) in Capture systems and SAS. - Review and resolve data queries prior to investigator submission. - Monitor and reconcile safety adverse events (SAEs). **Required Skills** - Advanced SAS programming. - Proficiency in EDC systems; Ennov Clinical expertise advantageous. - Knowledge of CDISC standards (SDTM) and database lock procedures. - Fluency in English (written and spoken). **Required Education & Certifications** - Bachelor’s or master’s degree in data management, statistics, or life sciences. - No specific certifications required, though CDISC SDTM familiarity is preferred.