3rd Party Data Acquisition Lead

3 weeks ago

Lexington, Kentucky, United States MaxisIT Inc. Full time
About the Role

We are seeking a highly skilled 3rd Party Data Acquisition Lead to join our team at MaxisIT Inc. as part of our Clinical Trials department.

Key Responsibilities
  • Subject Matter Expertise: Serve as the primary expert for the planning, setup, and acquisition of external clinical data at the study level, overseeing study start-up, conduct, and close-out activities.
  • Data Transfer Agreements: Create and manage external data transfer agreements, ensuring external clinical trial data align with client standards and specifications to support data integration, analysis, and reporting.
  • Infrastructure Setup: Assist in setting up infrastructure for external data to flow into client Clinical Data pipelines.
  • Data Validation: Responsible for validating all 3rd Party Data generated in clinical trials into client Clinical Data pipelines.
  • Stakeholder Relationships: Develop and maintain strong, productive working relationships with key stakeholders, including Clinical Data Management, Clinical Data Engineering, Standards, and other Study Execution Team members.
  • Submission Readiness: Participate in preparing the function for submission readiness and may represent the Clinical Trial Tools & Technologies (CT3) group in a formal inspection or audit.
  • External Partnerships: Represent the client in interactions with key external partners as part of the CT3 3rd Party Data Acquisition team.
  • Documentation Management: Responsible for timely submission and ongoing maintenance of study-related 3rd Party Data Acquisition documentation in the Trial Master File (TMF).
  • Procedural Documents: Follow procedural documents and participate in reviewing and updating documents to ensure they reflect industry standards and regulatory requirements, incorporating optimal processes.
  • External Partner Review: Liaise with and review work delivered by external partners (e.g., laboratories, eCOA providers, technology providers, etc.) performing services on behalf of the client.
  • Issue Escalation: Escalate issues to CT3 leadership as necessary.
Technical/Functional Expertise
  • Regulatory Knowledge: Working knowledge and understanding of FDA and ICH regulations and industry standards, as well as quality control principles.
  • Drug Development Experience: Experience with all phases of drug development.
  • Clinical Data Acquisition: Solid experience in handling Clinical data acquisition and management from external/3rd Party vendors.
  • Negotiation and Agreement: May lead study-level negotiation and agreement for data transfer or integration on behalf of the client.
  • Collaboration: Ability to function collaboratively with all levels of employees, with moderate supervision required.
  • Technical Skills: Knowledge of FTP tools like GlobalScape, Clinical platforms like Veeva CDMS, Elluminate, and Veeva TMF is a plus.

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