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Associate Director/Director, Data Management

climbbio · Wellesley Hills

New
Hybrid Senior 🇬🇧 English
clinical database architecture user acceptance testing GCP EDC platforms

Job description

About the role

Climb Bio is building its Phase 1‑through‑3 data management capability from the ground up. Reporting to the Vice President, Head of Biometrics, the Associate Director/Director will own database design, vendor management and delivery of clean, submission‑ready data.

Key responsibilities

  • Design and build clinical database architecture, establishing edit checks, structures and specifications that meet analysis and regulatory requirements.
  • Own end‑to‑end user acceptance testing (UAT) for database builds, from test plan development to final sign‑off.
  • Manage data management timelines and deliverables across studies, holding CROs and vendors accountable from first patient in through database lock.
  • Direct selection and performance oversight of data management CROs and vendors, serving as primary escalation point for data quality and timeline issues.
  • Partner with Biostatistics, Clinical Operations and Regulatory to align data management plans, CRF design and database specifications with study protocols.
  • Establish data management standards, SOPs and quality control processes that scale with the growing portfolio.
  • Lead data cleaning, query resolution and reconciliation to ensure inspection‑ready, submission‑quality data at lock.
  • Represent Data Management in cross‑functional program governance, reporting on timelines, risks and trade‑offs.

Required profile

  • Bachelor's degree in life sciences or related field.
  • 10+ years of clinical data management experience (12+ years for Director level), including taking a database through Phase 3 lock.
  • Demonstrated experience designing clinical databases and leading UAT execution.
  • Experience managing CRO and data management vendor relationships.
  • Working knowledge of GCP and applicable regulatory requirements.

Required skills

  • Clinical database architecture design.
  • User acceptance testing (UAT) execution.
  • CRO and vendor performance oversight.
  • Knowledge of GCP and regulatory data management standards.
  • Proficiency with industry‑standard clinical database and EDC platforms.

What we offer

  • Hybrid work arrangement based in Wellesley, MA.
  • Base salary commensurate with experience.
  • Discretionary annual bonus.
  • Comprehensive medical, dental and vision benefits.
  • Life & disability insurance, 401k match.
  • Generous paid time off and equity participation.

Questions fréquentes

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Source : ats:bamboohr

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Published 7 hours ago

Expires 1 month from now

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climbbio

Wellesley Hills