Clinical Operations Support Expert (Study Start Up) / EF / São José dos Campos,SP
Core
Provides end-to-end operational support for Phase I-IV clinical study start-up, site management, and quality compliance. (via careerplan.io/jobs/562949977753543-clinical-operations-support-expert-study-start-up-ef-sao-jose-dos-campossp-at-bayer)
Role type
Clinical Operations Specialist (Study Start-Up)
Builds
Clinical trial studies for patients
Domain
Healthcare / Clinical Research
Required skills
Regulatory dossier preparation, IRB/Ethics Committee submissions, Informed Consent Form (ICF) review, Good Clinical Practices (ICH-GCP) knowledge, local document quality checks, site activation planning, study supply management, post-site closeout activities, issue resolution, audit and inspection support
Preferred skills
Veeva system experience, U.S. regulatory package experience
Technologies
Gemstone, Veeva
Responsibilities
Execute study start-up activities including CDA, translations, ISF compilation, and greenlight process; Conduct local document quality checks; Coordinate provision and return of study supplies; Maintain study-relevant systems; Complete post-site closeout visit activities; Proactively identify and resolve compliance issues; Contribute to Site Audits and Regulatory Inspections
Seniority
Mid-level, hands-on IC