Job Description
Are you ready to shape the future of pharmaceutical research? Apex BioSciences is seeking a visionary Senior Clinical Data Manager to join our elite team in the heart of Boston. In this pivotal role, you will oversee the integrity and quality of clinical data across multiple Phase III trials, ensuring that our groundbreaking therapies reach patients safely and effectively.
We are not just a company; we are a community of innovators dedicated to saving lives. If you have a passion for data-driven decision-making and a commitment to regulatory excellence, this is your opportunity to lead with impact.
Why Join Us?
- Global Impact: Work on therapies that redefine treatment standards.
- Modern Environment: Access to cutting-edge EDC systems and agile methodologies.
- Competitive Benefits: Comprehensive health coverage, 401(k) matching, and continuous education stipends.
Responsibilities
- Lead Data Management Operations: Spearhead the design, development, and implementation of data management plans for complex clinical trials, ensuring alignment with ICH-GCP guidelines.
- Database Integrity: Oversee the creation and validation of Study Databases (CDISC SDTM/ADaM compliant) using leading EDC systems such as Oracle Clinical or Rave.
- Quality Assurance: Conduct rigorous data cleaning, range and logic checks, and resolve discrepancies (SDV/DCR) to maintain 100% data integrity.
- Stakeholder Collaboration: Act as the primary liaison between Clinical Operations, Biostatistics, and Regulatory Affairs to facilitate data flow and resolve critical issues.
- Process Optimization: Identify process gaps and implement best practices to improve data quality and timelines.
Qualifications
- Education: Bachelor’s degree in Life Sciences, Biostatistics, or a related field; Master’s degree is preferred.
- Experience: Minimum of 5-7 years of experience in Clinical Data Management within the pharmaceutical or biotechnology industry.
- Technical Proficiency: Expert knowledge of CDISC standards (SDTM, ADaM, SEND) and EDC systems (Rave, Oracle Clinical, Medidata Rave).
- Technical Skills: Proficiency in SQL, SAS, or R for data extraction and manipulation is required.
- Regulatory Knowledge: Deep understanding of FDA, EMA, and ICH guidelines regarding data integrity and submission requirements.