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Job Title: 3rd Party Data Acquisition Lead (FSP) Client: Takeda Location: Candidate must be on the East Coast Onsite/Remote: Remote Duration: 9+ Months Visa: USC, GC Must have fantastic communication skills and able to take a video screen with me today. 3rd Party Data Acquisition Lead (FSP) Role Profile - Serve as the subject matter expert for the planning, set-up, and acquisition of external clinical data at the study level and manage study start up, conduct, and close out activities. - Create external data transfer agreements, ensuring external clinical trial data are in alignment with company Standards and specifications to support data integration, analysis, and reporting. - Help and advice in setting up infrastructure for external data, to flow into company Clinical data pipelines. - Responsible for validation of all 3rd Party Data generated in clinical trial into company Clinical Data pipelines. - Develop strong and productive working relationships with key stakeholders like Clinical Data Management, Clinical Data Engineering, Standards, and other Study Execution Team members. - Participate in preparing function for submission readiness and may represent Clinical Trial Tools & Technologies (CT3) group in a formal inspection or audit. - Representing company in interactions with key external partners as part of company CT3 3rd Party Data Acquisition team. - Responsible for timely submission and on-going maintenance of study related 3rd Party Data Acquisition documentation in TMF. - Follow 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. - Liaise with and reviewing work delivered by external partners (e.g., laboratories, eCOA providers, technology providers, etc performing services on behalf of company. - Escalate issues to CT3 leadership appropriately. 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. - Solid Experience in handling Clinical data acquisition and management from external/3rd Party vendors. - May lead study level negotiation and agreement for data transfer or integration on behalf of company. - 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.