Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Responsibilities:
- Support the end-to-end clinical data management process for assigned studies, from protocol review to database lock.
- Collaborate with cross-functional teams, including clinical operations, biostatistics, and medical writing, to define data collection and reporting needs.
- Review and finalize clinical data management documentation, such as Data Management Plans (DMP), Case Report Forms (CRFs), and data validation specifications.
- Ensure adherence to applicable regulatory guidelines (e.g., FDA, ICH, GCP) and company standards for data management.
- Perform data cleaning, query resolution, and reconciliation of external data sources (e.g., lab data, ePRO).
- Support database setup, testing, and maintenance in partnership with external vendors or internal teams.
- Perform quality control and audit activities to ensure data accuracy and compliance.
- Support data reviews and provide metrics and status updates to project teams and leadership.
Requirements:
- Bachelor's degree in Life Sciences, Computer Science, or a related field.
- Minimum of 3 years of clinical data management experience in the pharmaceutical, biotech, or CRO industry.
- Proficiency in electronic data capture (EDC) systems, such as Medidata Rave, Oracle Clinical, or similar platforms.
- Strong knowledge of CDISC standards, including SDTM and ADaM.
- Excellent understanding of clinical trial processes and regulatory requirements (e.g., FDA, EMA).
- Exceptional attention to detail and problem-solving skills.
- Ability to work independently and communicate effectively with diverse stakeholders.