Associate Director, Clinical Data Management (Biotech)

Location: Boston, Massachusetts, United States; hybrid schedule with at least two on-site days per week, currently Tuesday and Wednesday

Salary: $181,000–$235,000 USD annually, with a discretionary annual bonus and potential long-term incentive award.

Company

hirify.global is a clinical-stage biotechnology company developing precision therapies for autoimmune and inflammatory diseases.

What you will do

• Lead clinical data management activities across one or more clinical programs from study start-up through database lock.
• Oversee Data Management Plans, CRF/eCRF specifications, data validation plans, custom reports, and data cleaning strategies.
• Manage EDC and clinical data system builds, user acceptance testing, database releases, interim snapshots, and database lock activities.
• Monitor data quality, study metrics, KPIs, discrepancy management, medical coding, and reconciliation of external data sources.
• Oversee CRO and vendor performance while communicating study status, risks, and mitigation strategies to cross-functional teams and program leadership.
• Support inspection readiness, audits, SOP development, process improvements, and complete Trial Master File documentation.

Requirements

• Bachelor’s degree in Life Sciences, Health Sciences, Computer Science, or a related discipline, or equivalent education and experience.
• At least 7 years of progressive clinical data management experience in the pharmaceutical, biotechnology, or CRO industry.
• Experience managing clinical data management activities across Phase I–III development, including late-stage or registration-enabling trials.
• Experience managing CRO relationships and outsourced clinical data management activities.
• Proficiency with EDC platforms such as Medidata Rave or Veeva Vault EDC and CDISC standards including CDASH, SDTM, and ADaM.
• Knowledge of data cleaning, query management, database locks, MedDRA, WHO Drug, centralized data review, risk-based monitoring, and applicable GCP and regulatory requirements.

Nice to have

• Experience in immunology or autoimmune therapeutic areas.

Culture & Benefits

• Hybrid work arrangement with flexible work options.
• Health and wellness coverage tailored to the hiring country and region.
• Paid time off, public holidays, and additional leave in accordance with local requirements.
• Inclusive workplace with equal employment opportunity commitments.