Senior Clinical Data Lead - Phase 1 & Oncology

Elixir Associates LTD; USA; Vor Ort; USD 120.000 - 170.000; Vollzeit

Zusammenfassung

Elixir Associates LTD is seeking an experienced Lead Clinical Data Manager to oversee data management activities for clinical development programmes, with emphasis on Phase 1 and oncology studies. The role involves leading from study setup to database lock and collaborating with cross-functional teams.

The ideal candidate will have strong experience with EDC systems, GCP and CDISC standards, plus proven leadership and vendor oversight capabilities.

Qualifikationen

• 7+ years of clinical data management experience.
• Phase 1 and oncology experience required.
• Vendor oversight and study leadership experience.
• Familiarity with GCP and CDISC standards.

Aufgaben

• Lead data management from study setup through database lock.
• Oversee eCRF development, database build, edit checks and UAT.
• Manage data cleaning, vendor oversight and data transfers.
• Collaborate with Clinical Operations, Biostatistics and Medical teams.
• Support improvements to data management processes.

Kenntnisse

Lead data management

Phase 1 experience

Oncology experience

Vendor oversight

EDC systems

GCP

CDISC standards

Tools

EDC software

Jobbeschreibung

Elixir Associates LTD is seeking an experienced Lead Clinical Data Manager to oversee data management activities for clinical development programmes, with emphasis on Phase 1 and oncology studies. The role involves leading from study setup to database lock and collaborating with cross-functional teams.

The ideal candidate will have strong experience with EDC systems, GCP and CDISC standards, plus proven leadership and vendor oversight capabilities.