Remote VP, Data Management & NDA Readiness

Amplitude Venture Capital; Boston (MA); Remote; USD 180,000 - 300,000; Full time

Job summary

Prilenia seeks a Vice President, Data Management, to lead strategy, build-out, and execution of clinical data management across the development portfolio in the US. You will own EDC, CDISC standards, database lock, and CRO/vendor oversight to ensure submission-ready data for regulatory authorities.

You will lead a hybrid internal/outsourced team, establish SOPs and governance, and work closely with Biostatistics, Regulatory Affairs and Quality to ensure 21 CFR Part 11 compliance and inspection

Qualifications

• 12+ years in clinical data management in pharma/biotech/CRO.

Responsibilities

• Lead data management strategy across trials aligned with regulatory timelines.
• Oversee DMPs, CRF design, edit checks, and data validation plans.
• Ensure submission-ready datasets and NDA/MAA data packages.
• Manage CROs/EDC vendors with budgets and timelines.
• Maintain inspection readiness and regulatory compliance.

Skills

CDISC standards

FDA Regulations

Vendor management

Cross-functional leadership

EDC/CDMS platforms

Data management strategy

Education

Advanced degree in life sciences or related field

12+ years clinical data management experience

Tools

Medidata Rave

Veeva Vault CDMS

Oracle InForm/Clinical One

Job description

Prilenia seeks a Vice President, Data Management, to lead strategy, build-out, and execution of clinical data management across the development portfolio in the US. You will own EDC, CDISC standards, database lock, and CRO/vendor oversight to ensure submission-ready data for regulatory authorities.

You will lead a hybrid internal/outsourced team, establish SOPs and governance, and work closely with Biostatistics, Regulatory Affairs and Quality to ensure 21 CFR Part 11 compliance and inspection