What are the responsibilities and job description for the Data Integration Coordinator position at Katalyst Healthcares & Life Sciences?
Clinical Data Manager Job Description
Katalyst Healthcares & Life Sciences is seeking a skilled Clinical Data Manager to support the planning, setup, and acquisition of external clinical data at the study level. This individual will assist in managing study start-up, conduct, and closeout activities, ensuring alignment with Takeda Standards and specifications.
The ideal candidate will have experience in creating external data transfer agreements, setting up infrastructure for external data to flow into Takeda Clinical data pipelines, and validating 3rd Party Data generated in clinical trials.
- Provide support in preparing function for submission readiness.
- May support Clinical Trial Tools & Technologies (CT3) group in formal inspections or audits.
- Act as a representative for Takeda in interactions with key external partners.
Requirements
- Develop a working knowledge and understanding of FDA and ICH regulations and industry standards and quality control principles.
- Gain exposure to all phases of drug development.
- Familiarity with FTP tools like GlobalSCAPE, Clinical platforms like Veeva CDMS, Elluminate, and Veeva TMF will be beneficial.
