CDM Associate Director — Data Quality & Submissions

BioSpace; Boston (MA); Hybrid; USD 181,000 - 235,000; Full time

Benefits offered by this job

Hybrid work schedule

Equity incentives (LTIP)

Health and welfare benefits

Job summary

Beeline Medicines is seeking an Associate Director, Clinical Data Management to lead data management activities across clinical programs. You will oversee CRO performance, DB design, and data cleaning strategy from study start-up to database lock, collaborating with Biostatistics, Clinical Operations, and QA to ensure audit-ready data for regulatory submissions.

The role requires 7+ years in CDM, CRO oversight, and strong knowledge of CDISC standards.

Qualifications

• Minimum 7 years of progressive experience in clinical data management within pharma, biotech or CRO.
• Experience in immunology or autoimmune therapeutic areas preferred.
• Proven experience managing CDM activities across all phases (I–III) including late-stage/registration trials.
• Experience managing CRO relationships and outsourced CDM activities.
• Proficiency with EDC platforms (Medidata Rave, Veeva Vault EDC) and CDISC standards.
• Strong written and verbal communication for cross-functional and vendor collaboration.
• Ability to lead cross-functional study teams and manage CRO performance without direct reporting authority.

Responsibilities

• Oversee development and review of Data Management Plans, CRF/eCRF design specs and data cleaning plans.
• Monitor data quality, study metrics and KPIs; ensure timely data cleaning and reconciliation.
• Coordinate with Biostatistics, Clinical Operations, and vendors to align data deliverables with milestones.
• Ensure compliance with ICH E6(R3) GCP, 21 CFR Parts 11/312, GDPR, HIPAA and global regulations.
• Support regulatory inspections and maintain documentation in the Trial Master File.
• Lead process improvements and SOP development across programs.

Skills

CDM Leadership

Vendor Management

Data Quality

Regulatory Compliance

CDISC/CDASH/SDTM

EDC Systems (Medidata Rave/Veeva)

Cross-functional Collaboration

Education

Bachelor’s degree in Life Sciences/Health Sciences/CS

Tools

Medidata Rave

Veeva Vault EDC

CDISC (CDASH/SDTM/ADaM)

Job description

Beeline Medicines is seeking an Associate Director, Clinical Data Management to lead data management activities across clinical programs. You will oversee CRO performance, DB design, and data cleaning strategy from study start-up to database lock, collaborating with Biostatistics, Clinical Operations, and QA to ensure audit-ready data for regulatory submissions.

The role requires 7+ years in CDM, CRO oversight, and strong knowledge of CDISC standards.