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
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Collaborate with cross-functional teams and vendors (CROs, EDC providers) to ensure data integrity
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Author and maintain key data management documentation (DMPs, CRFs, edit check specs)
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Ensure compliance with ICH-GCP, CDISC (SDTM), and FDA/EMA standards
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Use and manage clinical systems including Veeva Vault eTMF and EDC platforms (e.g., Rave, InForm)
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Oversee data query management and coding (MedDRA, WHODrug)
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Support regulatory submissions and inspection readiness
Qualifications
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Bachelor’s degree in life sciences or related field
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7+ years of clinical data management experience, with strong experience as Lead DM on global Phase III studies
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Proficiency with Veeva Vault eTMF, EDC systems, and CDISC standards
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Experience managing vendors and working across global teams
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Strong organizational and communication skills
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