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Associate Director/Director, Data Management

Climb Bio
Wellesley, USA
Full-time
Director · 10+ years experience
Onsite
$190,000-$250,000
Discovered 1 weeks ago
gcp

Full Job Posting

Key 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

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

Preferred Qualifications

  • Experience in a small, fast-paced biotech environment
  • Proficiency with industry-standard clinical database and EDC platforms
  • This is a hybrid position, based out of our Wellesley, MA office.
  • Base salary offered may vary depending on the individual’s skills, experience, and competitive market value.
  • Salary Range: $190,000-$250,000
  • Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, Life & Disability, 401k company match, generous paid time off, and equity.
  • For more information, please visit climbbio.com.
  • Climb is an Equal Opportunity Employer and we do not discriminate against any employee or applicant for employment because of race, color, sex, age, place of origin, religion, family status, sexual orientation, gender identity, status as a veteran, and disability or any other federal, state, provincial or local protected ground.

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