Job Description
We are seeking a visionary Senior Clinical Data Manager to join our elite team in Boston. In this pivotal role, you will oversee the integrity and quality of clinical trial data, ensuring it meets the rigorous standards of global regulatory bodies.
Our mission is to accelerate drug discovery and improve patient outcomes. As part of our cross-functional team, you will leverage cutting-edge data technologies to drive efficiency and compliance throughout the drug development lifecycle.
Why Join Us?
Competitive compensation, comprehensive benefits, and a collaborative culture that values innovation.
Responsibilities
- Lead the data management strategy for Phase II-IV clinical trials, ensuring adherence to CDISC standards (SDTM, Define-XML).
- Oversee the end-to-end data lifecycle, including data entry, cleaning, and validation, maintaining 100% data integrity.
- Establish and enforce Standard Operating Procedures (SOPs) and quality management systems in collaboration with QA.
- Act as the primary liaison between internal teams, Clinical Research Organizations (CROs), and sponsors.
- Utilize advanced statistical software (SAS, R, or Python) to identify and resolve data anomalies.
- Conduct comprehensive data audits and prepare reports for regulatory submissions.
Qualifications
- Bachelor’s degree in Life Sciences, Biostatistics, or a related field; Master’s degree preferred.
- Minimum of 5-7 years of experience in Clinical Data Management within the pharmaceutical or biotechnology industry.
- Proficiency in CDISC standards and experience with EDC systems (e.g., Rave, Oracle Clinical).
- Strong working knowledge of SQL and scripting languages (Python/R).
- Deep understanding of GCP (Good Clinical Practice) and regulatory requirements (FDA, EMA).
- Exceptional analytical skills with a keen eye for detail and accuracy.