Senior Associate Director, Global Clinical Data Management

Lever, Inc.; Cambridge, Northern (MA, KY); Hybrid; USD 185,000 - 220,000; Full time

Benefits offered by this job

Equity-based compensation

Medical, dental, vision insurance

401(k) retirement plan

Life insurance

Dependent care FSA

Job summary

Korro is seeking an Associate Director of Clinical Data Management in Cambridge, MA to lead data management for global studies, manage CRO relationships, and ensure regulatory-compliant, audit-ready data for submissions. The role partners with Clinical Development, Biostatistics, Regulatory, and Operations to align data strategy with study milestones and inspection-readiness.

Ideal applicants will have 8+ years in CDM, strong EDC expertise (Medidata Rave, Veeva Vault EDC), knowledge of CDISC

Qualifications

• Experience in clinical data management across Phase I–IV trials.
• Leadership of CRO relationships and data management activities.
• Knowledge of CDISC standards and regulatory guidance.

Responsibilities

• Lead data management for global studies from start-up to database lock.
• Oversee CRO performance and vendor relationships; ensure data quality.
• Develop DMPs, validation manuals, CRF completion guidelines, and data transfer specs.
• Collaborate with cross-functional teams to ensure inspection-readiness.
• Ensure compliance with ICH, FDA/EMEA standards and CDISC formats.

Skills

EDC platforms

CRO management

Regulatory knowledge

Data management

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences or related field

Tools

Medidata Rave

Veeva Vault EDC

Zetla

Job description

Korro is seeking an Associate Director of Clinical Data Management in Cambridge, MA to lead data management for global studies, manage CRO relationships, and ensure regulatory-compliant, audit-ready data for submissions. The role partners with Clinical Development, Biostatistics, Regulatory, and Operations to align data strategy with study milestones and inspection-readiness.

Ideal applicants will have 8+ years in CDM, strong EDC expertise (Medidata Rave, Veeva Vault EDC), knowledge of CDISC