Responsibilities :
- Support the planning, setup, and acquisition of external clinical data at the study level, assisting in managing study start-up, conduct, and closeout activities.
- Assist in creating external data transfer agreements, ensuring alignment and specifications to support data integration, analysis, and reporting.
- Provide support in setting up infrastructure for external data to flow into Clinical data pipelines.
- Assist in validation of all Data generated in clinical trials into Clinical Data pipelines.
- Develop and maintain working relationships with key stakeholders like Clinical Data Management, Clinical Data Engineering, Standards, and other Study Execution Team members.
- Assist in preparing function for submission readiness and may support Clinical Trial Tools & Technologies (CT) group in formal inspections or audits.
- Act as a representative for Takeda in interactions with key external partners as part of the CT Data Acquisition team.
Requirements :
- Support timely submission and ongoing maintenance of study-related Data Acquisition documentation in TMF.
- Follow procedural documents and assist in reviewing and updating documents to ensure they reflect industry standards and regulatory requirements and include optimal processes.
- Escalate issues to CT leadership as appropriate
- Develop working knowledge and understanding of FDA and ICH regulations and industry standards and quality control principles.
- Gain exposure to all phases of drug development.
- Assist in handling Clinical data acquisition and management
- May support study-level negotiation and agreement for data transfer or integration
- Collaborate with all levels of employees with moderate supervision required.
- Familiarity with FTP tools like Global cape, Clinical platforms like Veeva CDMS, Illuminate, and Veeva TMF will be beneficial.
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