Associate Director/Director, Data Management

Climb Bio, Inc.; Wellesley (MA); On-site; USD 170,000 - 210,000; Full time

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

Associate Director/Director, Data Management

About Climb:

Climb Bio is a clinical-stage biotechnology company developing therapeutics for patients with immune-mediated diseases. Our product candidates include budoprutug, an anti-CD19 monoclonal antibody that presents us with an exciting opportunity given its broad potential applicability across a number of B-cell mediated diseases, including systemic lupus erythematosus, immune thrombocytopenia, and membranous nephropathy and CLYM116, an anti-APRIL monoclonal antibody in development for IgA nephropathy.

At Climb Bio, our team has a knack for seeing what no one else sees—and a drive to achieve results no one expects. We believe that our combined strength conquers any summit, and our core values – Build Trust, Decide & Commit, Accelerate Impact, and Mark the Moment – guide how we work, collaborate and innovate.They reflect our commitment to patients, each other, and the pursuit of transformative science.

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. 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.