Clinical Data ManagerKatalyst HealthCares & Life Sciences • Cambridge, MA
Clinical Data Manager
Katalyst HealthCares & Life Sciences • Cambridge, MA
[job_card.30_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]
Responsibilities:
Responsibilities:
- Support the design, development, and validation of clinical trial databases and electronic Case Report Forms (eCRFs) at the study level.
- Oversee data cleaning, query resolution, and delivery of high-quality datasets to support trial milestones and regulatory submissions.
- Collaborate with external data management vendors to ensure timely and high-quality deliverables, track performance against project timelines and quality standards.
- Participate in the preparation, review, and validation of submission-ready datasets for regulatory filings (, NDA, BLA, MAA).
- Ensure compliance with industry standards and regulations (GCP, FDA, EMA) and assist in audit and inspection readiness.
- Coordinate with internal stakeholders including Clinical Operations, Biostatistics, Regulatory Affairs, and IT to ensure smooth data integration and reporting.
- Contribute to the implementation and optimization of clinical data systems and tools (, EDC, data review platforms).
- Bachelor's degree in Life Sciences, Data Science, Computer Science, or a related field.
- + years of experience in clinical data management within the biotech, pharmaceutical, or CRO industry.
- Experience managing study-level data management activities and working with external vendors.
- Familiarity with clinical data systems (, Medidata RAVE, Oracle Clinical, Veeva) and industry data standards (, CDISC, SDTM).
- Demonstrated experience supporting regulatory submissions is a plus.
- Strong problem-solving, organizational, and communication skills.
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