Lead Clinical Data Manager

Elixir Associates LTD; United States; On-site; USD 120,000 - 170,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Lead data management

Phase 1 experience

Oncology experience

Vendor oversight

EDC systems

GCP

CDISC standards

Tools

EDC software

Job description

We're partnering with one of the pioneers in AI-driven healthcare to recruit an experienced Lead Clinical Data Manager to support clinical development programmes, particularly Phase 1 and oncology studies.

This is an excellent opportunity to take ownership of clinical data management activities within a collaborative, forward-thinking environment.

Key Responsibilities:

• Lead data management activities 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.

What We're Looking For:

• 7+ years' clinical data management experience.
• Strong Phase 1 and oncology experience.
• Proven study leadership and vendor oversight experience.
• Expertise in EDC systems, GCP and CDISC standards.