About the job
Join our dynamic team as a 3rd Party External Data Acquisition Analyst!
Position Overview:
We are looking for an experienced professional with over 8 years of expertise in external data acquisition related to clinical trials. This role is essential in ensuring the integrity and quality of data sourced from various external vendors.
Key Responsibilities:
- Demonstrate a solid understanding of FDA and ICH regulations, including industry standards and quality control principles.
- Oversee all aspects of drug development phases, focusing on clinical data acquisition and management.
- Lead negotiations and agreements for data transfer and integration on behalf of our company.
- Collaborate with diverse teams while functioning independently with moderate supervision.
- Utilize FTP tools and clinical platforms such as GlobalScape, Veeva CDMS, Elluminate, and Veeva TMF.
- Act as a subject matter expert for the planning and acquisition of external clinical data.
- Develop and maintain external data transfer agreements to align with company standards.
- Assist in the infrastructure setup for integrating external data into our clinical data pipelines.
- Validate all 3rd Party Data generated during clinical trials.
- Foster strong relationships with stakeholders in Clinical Data Management and Study Execution Teams.
- Prepare documentation for submission readiness and represent the Clinical Trial Tools & Technologies group in inspections or audits.
- Engage with key external partners as part of our 3rd Party Data Acquisition team.
- Ensure timely documentation and maintenance of 3rd Party Data Acquisition records.
- Review and update procedural documents to reflect industry standards and regulatory requirements.
- Coordinate with external partners delivering services on behalf of the company.
- Escalate issues to CT3 leadership when necessary.

