Job Description
Are you ready to drive the next generation of life-saving therapies? VaxGen Therapeutics is seeking a highly skilled Clinical Data Manager to join our dynamic team in the heart of Boston's biotech hub.
As a pivotal member of our Data Operations department, you will ensure the integrity, quality, and compliance of our clinical trial data. We are looking for individuals who thrive in fast-paced environments and are committed to advancing global health through rigorous data management practices.
Why Join Us?
- Work with cutting-edge technology in a state-of-the-art facility.
- Competitive compensation and comprehensive benefits package.
- Opportunity for professional growth in a rapidly expanding industry.
Responsibilities
- Database Management: Lead the design, setup, and implementation of clinical databases using CDISC standards (SDTM, ADaM) and CDMS tools.
- Data Validation: Develop and execute comprehensive data validation plans to ensure data integrity and accuracy throughout the study lifecycle.
- Cleaning & QA: Perform detailed data cleaning activities, identify discrepancies, and collaborate with Clinical Research Associates to resolve queries.
- Regulatory Compliance: Ensure all data handling processes comply with Good Clinical Practice (GCP) and FDA 21 CFR Part 11 regulations.
- Reporting: Generate and analyze data reports to support study milestones and regulatory submissions.
Qualifications
- Education: Bachelor’s degree in Life Sciences, Bioinformatics, Statistics, or a related field (Master’s preferred).
- Experience: Minimum of 3-5 years of experience in Clinical Data Management within the pharmaceutical or biotechnology industry.
- Technical Skills: Proficiency in SQL, SAS, or R programming languages; experience with CDISC standards is highly required.
- Knowledge: Deep understanding of SDTM/ADaM implementation and data quality metrics.
- Communication: Excellent written and verbal communication skills with the ability to interact effectively with cross-functional teams.