Job Description

• 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 (CT3) group in formal inspections or audits.



• Act as a representative for Takeda in interactions with key external partners as part of the CT3 Data Acquisition team.



• 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 CT3 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 GlobalScape, Clinical platforms like Veeva CDMS, Elluminate, and Veeva TMF will be beneficial.

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