What are the responsibilities and job description for the Study Start-Up and Data Management Expert position at Katalyst Healthcares & Life Sciences?
Data Acquisition and Management
We are 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.
- Collaborate with all levels of employees with moderate supervision required.
- Support study-level negotiation and agreement for data transfer or integration on behalf of Takeda.
- Escalate issues to CT3 leadership as appropriate.
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.
- Developing working knowledge and understanding of GCP, GDPR, HIPAA principles and related regulations is essential
