Director, Data Management — Clinical Data Strategy

uniQure

Lexington (MA)

On-site

USD 205,000 - 265,000

Full time

2 days ago

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Job summary

uniQure in Lexington, MA, seeks a Director of Data Management to lead end-to-end DM activities across multiple programs, oversee CRO vendors, and drive functional development with senior management. You will partner with Biostatistics, Clinical Operations, and Medical teams in a fast-paced, regulated environment.

The ideal candidate combines an advanced life sciences degree with 10+ years in biotech or pharma DM, strong leadership, and in-depth knowledge of CDISC SDTM/ADaM and SAS, plus

Qualifications

Advanced degree (Master's or PhD) in life sciences, data science, biostatistics or relevant field
10+ years of progressive Data Management experience in Biotech or Pharmaceutical industry
Deep experience in clinical Data Management: database design, data management plans, CDISC SDTM/ADaM, SAS
Solid understanding of clinical trial process and regulatory interactions
Strong leadership and communication skills

Responsibilities

Lead end-to-end Data Management activities across multiple clinical programs and studies, including CRO oversight
Serve as internal SME to address Data Management questions, monitor processes, and develop SOPs
Lead Data Management in audits and regulatory interactions
Oversee budget planning, functional RFPs, and vendor selection

Skills

Leadership

Communication

Vendor Management

SAS

CDISC SDTM/ADaM

Education

Advanced degree (Master's or PhD)

Tools

SAS

CDISC Standards

Job description

The ideal candidate combines an advanced life sciences degree with 10+ years in biotech or pharma DM, strong leadership, and in-depth knowledge of CDISC SDTM/ADaM and SAS, plus

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