Job Description
VaxGen Therapeutics is a pioneering biopharmaceutical company dedicated to discovering breakthrough treatments for chronic diseases. We are looking for a Senior Clinical Data Manager to join our dynamic team in Boston, MA. In this role, you will ensure the integrity, quality, and security of clinical trial data, driving the success of our global development programs.
Why Join Us?
- Work on life-changing therapies with a world-class R&D team.
- Competitive compensation and comprehensive benefits package.
- Flexible work environment with a focus on work-life balance.
Key Responsibilities:
Responsibilities
- Lead the data management strategy for Phase III clinical trials, ensuring compliance with ICH-GCP and FDA regulations.
- Design and implement Data Management Plans (DMPs) and define data standards to support statistical analysis.
- Conduct thorough data validation, reconciliation, and error resolution processes.
- Collaborate cross-functionally with biostatisticians, medical writers, and clinical operations teams.
- Oversee the training and mentorship of junior data management staff.
- Manage the data transfer process to external CROs and vendors.
- Participate in regulatory inspections and audit preparation activities.
Qualifications
- Master’s degree in Life Sciences, Biostatistics, or a related field (Bachelor’s degree with 7+ years of experience considered).
- Minimum of 5-7 years of experience in Clinical Data Management within the pharmaceutical or biotechnology sector.
- Expert proficiency in clinical data capture systems (e.g., Rave, Oracle Clinical, Medidata Rave).
- Strong command of statistical programming languages such as SAS, R, or SQL.
- Deep understanding of CDISC standards (SDTM, ADaM) and regulatory reporting requirements.
- Excellent communication skills with the ability to present complex data findings to diverse audiences.