Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Responsibilities:
- Lead CDM activities for assigned clinical studies, ensuring data quality and compliance with study timelines.
- Design and/or support the design of clinical databases in alignment with study protocols and requirements, including creation of edit checks and dynamic functionalities.
- Conduct User Acceptance Testing (UAT) to validate clinical database functionality and accuracy.
- Author, review, and approve study-specific CDM documentation such as Data Management Plans (DMPs), Case Report Form Completion Guidelines (CCGs), Data Transfer Agreements (DTAs), and EDC specifications.
- Support data cleaning and validation activities to ensure completeness and accuracy of study data.
- Monitor study progress to ensure milestones are met and deliverables are achieved on schedule.
- Oversee and manage CDM vendors to ensure high-quality deliverables and adherence to project timelines.
- Ensure all CDM operations comply with applicable Standard Operating Procedures (SOPs) and regulatory guidelines.
- Identify and communicate potential risks or challenges to the Head of CDM and Clinical Project Manager (CPM) and collaborate with the study team to develop and implement risk mitigation strategies.
- Ensure timely and accurate filing of CDM documentation in the Trial Master File (TMF).
- Supervise and provide guidance to junior CDM staff on assigned studies.
- Perform additional CDM-related duties as required.
Requirements:
- Bachelor's degree in a health-related, scientific, or equivalent field.
- 5 8 years of experience in Clinical Data Management role.
- Strong understanding of Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) guidelines, and CDM processes.
- Hands-on experience with multiple Electronic Data Capture (EDC) systems.
- Familiarity with additional CDM tools and analytics platforms preferred.
- Advanced proficiency in Microsoft Excel (formulas, pivot tables); basic knowledge of SAS or other programming languages is an advantage.
- Proficient in Microsoft Office Suite, Microsoft Teams, and SharePoint.
- Excellent written and verbal communication skills.
- Strong organizational skills with keen attention to detail.
- Proven ability to prioritize, manage multiple tasks, and meet deadlines effectively.