Senior Director, Global Clinical Data Management

Korro Bio, Inc.; Cambridge (MA); On-site; USD 185,000 - 220,000; Full time

Benefits offered by this job

Equity-based compensation

Medical

Dental

Vision

401(k) retirement plan

Life insurance

Dependent care FSA

Company-funded HSA

Job summary

Korro Bio, Inc. seeks an Associate Director of Clinical Data Management to lead DM activities across global studies, ensuring audit-ready data for regulatory submissions. You will manage CRO performance, database builds, data cleaning strategies, and data transfer processes from startup to database lock.

The role requires strong communication, cross-functional collaboration, and a deep understanding of ICH, GCP, and CDISC standards in a fast-paced, innovative biopharma setting in Cambridge, MA.

Qualifications

• Bachelor's degree in Life Sciences, Computer Science, or a related field; advanced degree preferred.
• Minimum of 8 years of progressive experience in clinical data management/clinical trials across Phase I–IV.
• Experience managing CRO relationships and overseeing outsourced CDM activities; ability to lead cross-functional teams.
• Proficient in EDC platforms (e.g., Medidata Rave, Veeva Vault EDC, Zetla).
• Knowledge of FDA/EMEA/I CH GCP and CDISC standards (CDASH/SDTM/ADaM).
• Excellent communication and ability to work independently in a fast-paced environment.
• Embrace Korro's core values: Rewrite the Future; On the Cutting Edge; Better Together; Dynamically Different; Kindness and Integrity.

Responsibilities

• Demonstrate deep expertise in a regulated environment with regulatory data and documentation.
• Author, review, and maintain data management SOPs, work instructions, and training materials.
• Serve as the DM SME for global studies/programs, including EDC, external data, and data standardization.
• Collaborate with Clinical Development, Biostatistics, Regulatory, and Operations teams.
• Provide input on study protocols and data management plans to ensure quality data collection.
• Oversee Data Management deliverables including DM Plans, Data Validation Manuals, CRF Guidelines, and Transfer Specifications.
• Coordinate CRO data cleaning, data reviews, and issue tracking across programs.
• Establish data transfer guidelines with CROs and external vendors; reconcile external data transfers.
• Ensure data system compliance with national and international regulations.
• Support close-out audits and contribute to process improvements within the department.
• Accountable to deliver studies within budget and align with study milestones.

Skills

CDM leadership

Regulatory liaison

Cross-functional collaboration

Data quality assurance

EDC systems

Education

Bachelor's degree in Life Sciences or related

Tools

Medidata Rave

Veeva Vault EDC

Zetla

Job description

Korro Bio, Inc. seeks an Associate Director of Clinical Data Management to lead DM activities across global studies, ensuring audit-ready data for regulatory submissions. You will manage CRO performance, database builds, data cleaning strategies, and data transfer processes from startup to database lock.

The role requires strong communication, cross-functional collaboration, and a deep understanding of ICH, GCP, and CDISC standards in a fast-paced, innovative biopharma setting in Cambridge, MA.