Associate Director, Clinical Data Management — Data Strategy Lead

Xtalks; Cambridge (MA); On-site; USD 185,000 - 220,000; Full time

Benefits offered by this job

Equity-based compensation

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Life insurance

Dependent care FSA

Health savings account

Free parking

Job summary

Korro, based in Cambridge, MA, seeks an Associate Director of Clinical Data Management to lead global data management activities from study start-up to database lock, coordinating with CROs and vendors to ensure audit-ready data for regulatory submissions.

The role requires strong HCP communication, robust EDC expertise (Medidata Rave, Veeva Vault EDC), and deep regulatory knowledge to drive data quality in a fast-paced environment.

Qualifications

• 8+ years in clinical data management across Phases I–IV.
• Experience managing CRO relationships and outsourcing CDM.
• Proficient in EDC platforms and data management processes.
• Knowledge of CDISC standards (CDASH/SDTM/ADaM) and regulatory guidance.

Responsibilities

• Lead data management from start-up through database lock.
• Oversee CRO/vendor performance and data cleaning strategies.
• Ensure data management deliverables for regulatory submissions.
• Develop DM Plans, validation manuals, and data transfer specs.
• Support inspection readiness and cross-functional data governance.

Skills

CDM leadership

CRO management

Regulatory knowledge

EDC platforms

Education

Bachelor's degree in Life Sciences / CS

Advanced degree preferred

Tools

Medidata Rave

Veeva Vault EDC

Zetla

Job description

Korro, based in Cambridge, MA, seeks an Associate Director of Clinical Data Management to lead global data management activities from study start-up to database lock, coordinating with CROs and vendors to ensure audit-ready data for regulatory submissions.

The role requires strong HCP communication, robust EDC expertise (Medidata Rave, Veeva Vault EDC), and deep regulatory knowledge to drive data quality in a fast-paced environment.