Job Description

Hybrid/Remote
12 month contract with room for extension

Summary

We are seeking a skilled Lead Data Manager or Manager/AD of Data Management to drive data management activities for global Phase III clinical trials. This role will encompass both lead activities and also support activities across a couple of different studies.

Key Responsibilities

• Collaborate with cross-functional teams and vendors (CROs, EDC providers) to ensure data integrity

• Author and maintain key data management documentation (DMPs, CRFs, edit check specs)

• Ensure compliance with ICH-GCP, CDISC (SDTM), and FDA/EMA standards

• Use and manage clinical systems including Veeva Vault eTMF and EDC platforms (e.g., Rave, InForm)

• Oversee data query management and coding (MedDRA, WHODrug)

• Support regulatory submissions and inspection readiness

Qualifications

• Bachelor's degree in life sciences or related field

• 7+ years of clinical data management experience, with strong experience as Lead DM on global Phase III studies

• Proficiency with Veeva Vault eTMF, EDC systems, and CDISC standards

• Experience managing vendors and working across global teams

• Strong organizational and communication skills

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Job Tags

Contract work,

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