Associate Director, Clinical Data Management (Biotech)

TL;DR

Associate Director, Clinical Data Management (Biotech): Overseeing clinical data management activities, CRO vendor relationships, and study database integrity for rare disease clinical trials with an accent on regulatory compliance and standardization. Focus on managing EDC systems, authoring SOPs, and ensuring high-quality data delivery across multiple phases of clinical development.

Location: Must be based in the U.S. (Fully remote with 15% travel requirement).

Salary: $164,000–$213,000 Annual

Company

A global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases.

What you will do

• Manage and oversee data management activities with CROs and external vendors.
• Review and revise study plans, including Data Management and Data Validation plans.
• Oversee the design and development of eCRFs and edit check specifications.
• Participate in monthly data reviews to ensure accuracy, consistency, and reliability.
• Develop and revise global SOPs and provide team training.
• Support regulatory submissions by managing data transfer and database lock processes.

Requirements

• Must be based in the U.S.
• Bachelor’s degree in a relevant field.
• Extensive experience in clinical data management within a biotech, pharmaceutical, or CRO environment.
• Three years of prior management experience.
• Hands-on experience with Medidata Rave.
• Proven experience in CRO and vendor management, including budgeting and auditing.

Nice to have

• Advanced degree.

Culture & Benefits

• Comprehensive medical, dental, and vision coverage with mental health support.
• 401(k) plan with company match and annual equity awards.
• Generous paid time off and family-forming benefits.
• Access to Company Learning Institute and professional development resources.
• Flexible work schedules with purposeful in-person collaboration.