3rd Party Data Acquisition Lead

MaxisIT Inc. • lexington, ky, us • 3m ago

Serving as the subject matter expert for the planning, set-up, and acquisition of external clinical data at the study level, managing study start up, conduct and close out activities.
Creating external data transfer agreements, ensuring external clinical trial data are in alignment with the client Standards and specifications to support data integration, analysis, and reporting.
Help and advice in setting up infrastructure for external data, to flow into client Clinical data pipelines.
Responsible for validation of all 3rd Party Data generated in clinical trial into client Clinical Data pipelines.
Developing strong and productive working relationships with key stakeholders like Clinical Data Management, Clinical Data Engineering, Standards and other Study Execution Team members.
Participates in preparing function for submission readiness and may represent Clinical Trial Tools & Technologies (CT3) group in a formal inspection or audit.
Representing client in interactions with key external partners as part of client CT3 3rd Party Data Acquisition team
Responsible for timely submission and on-going maintenance of study related 3rd 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 client.
Escalating 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 Client.
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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