Job Description
Are you a visionary Clinical Data Manager ready to shape the future of healthcare? Vaxion Therapeutics is seeking a dynamic Senior Clinical Data Manager to join our elite team in Cambridge, MA. In this pivotal role, you will oversee the integrity and quality of data across our global clinical trials, ensuring that our breakthrough therapies reach patients safely and effectively.
Join a company that values innovation, precision, and the profound impact of scientific discovery. You will work in a fast-paced, collaborative environment alongside world-class scientists and medical experts.
Responsibilities
- Design and develop data collection tools, including electronic data capture (EDC) systems and case report forms (CRFs), ensuring alignment with CDISC standards.
- Oversee the overall data management lifecycle, from data entry and cleaning to database lock and final deliverables.
- Lead cross-functional teams to resolve data queries, ensuring 100% data integrity and compliance with Good Clinical Practice (GCP).
- Collaborate with biostatisticians and clinical operations to define data collection strategies and statistical analysis plans.
- Manage third-party vendor relationships and conduct regular audits to maintain quality standards.
- Ensure all data processes are compliant with regulatory bodies, including FDA, EMA, and ICH guidelines.
Qualifications
- Bachelor’s or Master’s degree in Bioinformatics, Biostatistics, Life Sciences, or a related field.
- Minimum of 5-7 years of experience in Clinical Data Management within the pharmaceutical or biotechnology industry.
- Expert proficiency in CDISC standards (SDTM, ADaM) and data management tools (e.g., R, SAS, SQL, Tableau, or Veeva Rave).
- Strong understanding of GCP, 21 CFR Part 11, and regulatory submissions.
- Exceptional problem-solving skills and the ability to manage multiple priorities in a fast-paced environment.
- Proven track record of leading teams and mentoring junior data managers.