3rd party data acquisition Study Analyst

• Serve as the subject matter expert for planning, setup, and acquisition of external clinical data at the study level, managing study startup, conduct, and closeout activities.
• Create external data transfer agreements, ensuring alignment with company standards and specifications to support data integration, analysis, and reporting.
• Provide guidance in setting up infrastructure for external data flow into company clinical data pipelines.
• Oversee the validation of all third-party data generated in clinical trials, ensuring accurate integration into company clinical data pipelines.
• Develop strong and productive working relationships with key stakeholders, including Clinical Data Management, Clinical Data Engineering, Standards, and other Study Execution Team members.
• Support submission readiness efforts and may represent the Clinical Trial Tools & Technologies (CT3) group in formal inspections or audits.
• Represent the company in interactions with key external partners as part of the CT3 Third-Party Data Acquisition team.
• Ensure timely submission and ongoing maintenance of study-related third-party data acquisition documentation in the Trial Master File (TMF).
• Adhere to procedural documents and participate in their review and updates to ensure compliance with industry standards, regulatory requirements, and best practices.
• Collaborate with and review work delivered by external partners (e.g., laboratories, eCOA providers, technology providers) performing services on behalf of the company.
• Escalate issues to CT3 leadership as needed.

Technical/Functional Expertise:

• Strong working knowledge of FDA and ICH regulations, industry standards, and quality control principles.
• Experience across all phases of drug development.
• Extensive experience in clinical data acquisition and management from external/third-party vendors.
• Ability to lead study-level negotiations and agreements for data transfer or integration on behalf of the company.
• Strong collaboration skills, with the ability to work effectively across all levels of the organization with moderate supervision.
• Familiarity with FTP tools like Global Scape and clinical platforms such as Veeva CDMS, Elluminate, and Veeva TMF is a plus.