3rd Party Data Acquisition Study Analyst
2 days ago
Job Description
Role : 3rdParty Data Acquisition Study Analyst (FSP)
Duration of Project: 12 months to start
Mode of Interview: MS Teams
3rdParty Data Acquisition Study Analyst (FSP) Role Profile
Facilitate the acquisition of external clinical data at the study level, managing the start-up, conduct, and close-out activities of studies.
Creating external data transfer agreements, ensuring external clinical trial data are in alignment with the Takeda Standards and specifications to support data integration, analysis, and reporting.
Responsible for validation of all Third Party Data generated in clinical trial into Takeda Clinical Data pipelines.
Identify risks and issues in setup of data transfer to Takeda study execution team and CT3 leadership
Support Third Party Data Acquisition Study Lead in preparing function for submission readiness and may represent CT3 group in a formal inspection or audit.
Responsible for timely submission and on-going maintenance of study related Third Party Data Acquisition documentation in TMF
Following procedural documents and participating in reviewing and updating documents to make sure they are reflective of industry standards and regulatory requirements and include optimal processes.
Liaising with and reviewing work delivered by external partners (e.g. laboratories, eCOA providers, technology providers, etc.) performing services on behalf of Takeda.
Escalating issues to Third Party Data Acquisition Study Lead appropriately
Conduct regular quality checks to ensure the proper functioning of data transfers at all times.
Technical/Functional Expertise
Working knowledge and understanding of FDA and ICH regulations and industry standards and quality control principles.
Experience with all phases of drug development
Must have problem-solving, advanced computer skills, data collection, teamwork, mathematical skills, analyzing capability, attention to detail, and effective communication
Solid Experience in handling Clinical data acquisition and management from external/3rdParty vendors
May lead study level negotiation and agreement for data transfer or integration on behalf of Takeda.
should be able to function collaboratively (with some guidance) with all levels of employees, moderate supervision required
Knowledge on FTP tools like GlobalScape, Clinical platforms like Veeva CDMS, Elluminate and Veeva TMF will be a plus.
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