Data Acquisition Specialist
RIT Solutions
Clinical Data Acquisition SpecialistServe 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 ExpertiseWorking 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.
$245k - $255k
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