We are looking for an Associate Director, Data Management to oversee end-to-end clinical data operations across multiple studies. The successful candidate will have expertise in electronic data capture systems, clinical database design, and regulatory compliance standards.
Requirements
- Bachelor’s degree or higher in a life sciences-related field or equivalent experience.
- 9+ years of experience in clinical data management within biotech/pharmaceutical industries or service providers, including 3+ years in a lead data management role.
- Hands-on experience in all phases of clinical trials, including database design, validation, deployment, and closeout.
- Strong knowledge of CDISC data standards, ICH GCP guidelines, and global clinical data management best practices.
- Proficiency with clinical data management systems (e.g., Medidata Rave) and external data sources (IRT, labs, safety, PROs, reading centers).
- Demonstrated ability to manage vendors and assess performance effectively.
- Excellent organizational, project management, analytical, and strategic thinking skills.
- Strong written and verbal communication skills and ability to collaborate in a high-paced, small company environment.
- Attention to detail, multitasking ability, and adaptability to shifting priorities and deadlines.
- Experience in retina diseases and/or gene therapy programs is a plus.
- Willingness to travel up to 5% as needed.
Benefits
- Competitive base salary ($170,000 – $223,000/year, adjusted based on experience and location).
- Comprehensive health, dental, and vision insurance coverage.
- Retirement savings plan options.
- Paid time off, holidays, and flexible work arrangements.
- Opportunities for professional growth, mentorship, and leadership development.
- Collaborative and supportive team environment in a dynamic and innovative biotech setting.