Senior Data Management Director - Clinical DB Lead

Climb Bio, Inc.

Wellesley (MA)

Hybrid

USD 170,000 - 210,000

Full time

5 days ago
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Benefits offered by this job

Medical insurance
Dental insurance
Vision insurance
Life & Disability insurance
401(k) with company match
Generous PTO
Equity

Job summary

Climb Bio, Inc. in Massachusetts is seeking an Associate Director/Director, Data Management to design and oversee the clinical database architecture across studies, ensuring regulatory alignment and data integrity.

You will lead UAT, manage CRO vendors, collaborate with Biostatistics, Clinical Operations and Regulatory, and help scale Data Management as the portfolio grows. Hybrid work in Wellesley, MA is offered.

Qualifications

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

Responsibilities

  • Design and build the clinical database architecture for clinical studies, establishing edit checks, structures, and specifications that meet the program's analysis and regulatory requirements
  • Own user acceptance testing (UAT) for clinical database builds end-to-end, from test plan development through final sign-off prior to DB going live
  • Manage data management timelines and deliverables across clinical studies, holding vendors accountable to milestones from first patient in through database lock
  • Direct the selection and ongoing performance oversight of data management CROs and vendors, serving as the 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 as Climb Bio's clinical portfolio grows
  • Lead data cleaning, query resolution, and reconciliation activities to ensure inspection-ready, submission-quality data at database lock
  • Represent Data Management in cross-functional program governance, reporting on database timelines, risks, and trade-offs

Skills

Clinical data management
UAT leadership
Vendor management
GCP compliance

Education

Bachelor's degree in life sciences

Tools

EDC platforms
Database design tools

Job description

Climb Bio, Inc. in Massachusetts is seeking an Associate Director/Director, Data Management to design and oversee the clinical database architecture across studies, ensuring regulatory alignment and data integrity.

You will lead UAT, manage CRO vendors, collaborate with Biostatistics, Clinical Operations and Regulatory, and help scale Data Management as the portfolio grows. Hybrid work in Wellesley, MA is offered.

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