Job Description
We are seeking a visionary Senior Clinical Data Manager to join our elite team in Boston, MA. In this pivotal role, you will oversee the entire lifecycle of clinical data, ensuring the integrity, quality, and compliance of our global drug development programs. We are committed to accelerating the delivery of life-changing therapies through cutting-edge data management practices and collaborative innovation.
As a leader in the pharmaceutical sector, we offer a competitive benefits package, including comprehensive health coverage, a 401(k) match, and continuous professional development opportunities. If you are passionate about data quality and want to make a tangible impact on patient health, we want to hear from you.
Responsibilities
- Lead the design, development, and implementation of Data Management Plans (DMPs) in alignment with regulatory standards (ICH-GCP).
- Ensure strict adherence to CDISC standards (SDTM, ADaM) and 21 CFR Part 11 compliance across all clinical trials.
- Manage and mentor a team of Data Managers and Data Entry Specialists, fostering a culture of excellence and continuous improvement.
- Conduct rigorous data quality checks and audits to identify discrepancies, trends, and potential risks early in the study lifecycle.
- Collaborate closely with Clinical Operations, Biostatistics, and Medical Writing teams to ensure seamless data flow and interpretation.
- Oversee the validation of electronic data capture (EDC) systems and external vendor deliverables.
Qualifications
- Master’s degree in Bioinformatics, Life Sciences, Pharmacy, or related field preferred; Bachelor’s degree with significant experience considered.
- Minimum of 5-7 years of progressive experience in Clinical Data Management within the biopharmaceutical or CRO industry.
- Expert proficiency in data manipulation languages such as SAS, R, or SQL.
- Strong working knowledge of CDISC standards (SDTM, ADaM) and clinical data integration methodologies.
- Proven track record of leading cross-functional projects and managing complex datasets.
- Excellent communication skills with the ability to present technical findings to non-technical stakeholders.