Clinical Data Manager-Philippines
Core
Manage clinical data for dermatology and rheumatology clinical trials, ensuring accurate collection, management, and reporting in compliance with regulatory guidelines.
Role type
Senior Clinical Data Manager (Dermatology/Rheumatology)
Builds
Clinical databases and electronic data capture (EDC) systems for biotech and pharmaceutical sponsors
Domain
Clinical Research / Biotechnology / Pharmaceuticals / Dermatology
Required skills
Clinical data management, EDC system programming and maintenance, CDISC SDTM/CDASH standards, MedDRA and WHODrug dictionaries, data cleaning and validation, vendor management, SOP development
Preferred skills
M.Sc. in related field, experience in Good Clinical Practices (GCP), ICH Guidelines, Health Canada and FDA regulations
Technologies
EDC systems, clinical database structures
Responsibilities
Develop eCRF specifications and data management plans (DMP), program and validate clinical databases, conduct data review/cleaning, train site users and monitors, manage external vendors, generate data listings and reports, maintain trial master file (TMF), mentor Clinical Data Coordinators
Seniority
Senior, hands-on IC (via careerplan.io/jobs/15-003-2D-27D-clinical-data-manager-philippines)