Clinical Data Manager
4 days ago
Job Summary:
We are seeking a highly skilled Clinical Data Manager to join our team at Katalyst Healthcares and Life Sciences. As a Clinical Data Manager, you will play a critical role in ensuring the accuracy and quality of clinical trial data.
Key Responsibilities:
- Provide oversight and guidance on data collection and management for outsourced and in-house trials.
- Establish and maintain strong relationships with internal teams, vendors, and clinical research site personnel.
- Lead the development of Electronic Data Capture (EDC) systems, including user acceptance testing plans and test scripts.
- Oversee the set-up of clinical management systems and data transfer agreements with external vendors.
- Write and contribute to the preparation of Clinical Data Management documents.
- Develop EDC custom and Business Objective reports, SAS clinical programming report specifications, and data visualization output.
- Collaborate with the Study Execution Team to review clinical documents, including protocols, statistical analysis plans, and protocol deviation plans.
- Report Data Management metrics and trends, identifying barriers to timely and successful trial execution and proposing solutions.
Requirements:
- Bachelor's Degree in life sciences or a related discipline.
- 6+ years of experience in clinical data management or relevant work experience.
- CRO or CDM vendor management experience in oncology.
- Early phase adaptive trial management experience preferred.
- Experience with CDASH terminology and/or MedDRA and Who Drug medical coding.
- Experience with SAS programming techniques is a plus.
- Experience with RaveX and/or Veeva EDC is a plus.
- Experience with Spotfire is a plus.
- Strong working knowledge of CDISC standards, FDA, and ICH/GCP regulations and guidelines.
- Proficient in EDC configuration and design, testing and validation, data collection and data review process, and data standardization.
What We Offer:
We offer a dynamic and supportive work environment, opportunities for professional growth and development, and a competitive compensation package.
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