Job Description
Join the Future of Medicine
Nexus BioSciences is a pioneering biotechnology firm dedicated to discovering breakthrough therapies for rare diseases. We are currently seeking a highly skilled and motivated Senior Clinical Data Manager to join our dynamic R&D team in San Diego. In this pivotal role, you will oversee the integrity, quality, and timeliness of clinical trial data, ensuring our research meets the highest regulatory standards.
Why Join Us?
• Competitive Salary and Comprehensive Benefits
• Work in a state-of-the-art biotech hub
• Opportunities for professional growth and leadership
• Collaborative culture focused on innovation and patient impact
Responsibilities
- Lead Data Management Operations: Oversee the entire data management lifecycle for multiple Phase II/III clinical trials, ensuring deliverables are met on time and within scope.
- CDISC Compliance: Ensure all data sets adhere to CDISC standards (SDTM, ADaM) and regulatory guidelines (FDA, EMA).
- Quality Assurance: Implement and audit data cleaning plans, resolve data queries, and maintain a high standard of data integrity.
- EDC System Management: Configure and manage Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Oracle Clinical) and oversee database lock processes.
- Interdisciplinary Collaboration: Act as the primary point of contact for cross-functional teams, including Clinical Operations, Biostatistics, and Medical Writing.
- Process Improvement: Identify areas for process optimization in data management workflows and implement best practices.
Qualifications
- Education: Bachelor’s or Master’s degree in Biostatistics, Life Sciences, Pharmacology, or a related field.
- Experience: Minimum of 5+ years of experience in clinical data management within the pharmaceutical or biotechnology industry.
- Technical Skills: Proficiency in CDISC standards (SDTM, ADaM), Clinical Data Interchange Standards Consortium, and experience with Medidata Rave is highly preferred.
- Statistical Software: Strong working knowledge of statistical programming languages such as SAS, R, or Python.
- Regulatory Knowledge: In-depth understanding of GCP (Good Clinical Practice) and FDA 21 CFR Part 11 regulations.
- Leadership: Demonstrated ability to lead data management teams and mentor junior staff.