Clinical Data Team Lead - External Data Acquisition
By Admin · Clinical Data Management
ROLE OVERVIEW
Lead end-to-end external clinical data acquisition across multiple studies, ensuring accurate, timely, validated, and audit-ready integration of non-CRF data. Partner with vendors, clients, programmers, Data Standards, Clinical Operations, Biostatistics, and IT to deliver high-quality clinical data.
ROLE DEFINITION & RESPONSIBILITIES
- •Review protocols and study materials to identify non-CRF data requirements and develop acquisition strategies
- •Develop, negotiate, and maintain Data Transfer Agreements and Data Transfer Specifications for validated external data ingestion
- •Manage end-to-end external data acquisition across multiple concurrent clinical studies and ensure accurate and timely delivery
- •Lead vendor management for eCOA/ePRO and other external data providers, including setup, configuration, deliverables, and issue resolution
- •Plan and execute UAT for applications, notifications, and reports, including test scripts, defect management, and validation summaries
- •Provide technical expertise on SDTM mappings, XML/JSON, CSV, SFTP, APIs, transformation, and ingestion processes
- •Maintain audit-ready CDM documentation, communicate risks and status, mentor junior staff, and coordinate with CDM, Data Standards, Biostatistics, Clinical Operations, and IT
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Bachelor's degree or equivalent relevant academic or vocational qualification
- 6+ years of experience in end-to-end Clinical Data Management activities
- Experience leading and executing non-CRF external data acquisition across clinical study setup, conduct, and closeout
- Strong understanding of clinical data management processes, regulatory guidelines, SOPs, and client expectations
- Strong analytical, problem-solving, organizational, communication, and leadership skills
- Ability to work independently, maintain confidentiality, and train or direct study team members
PREFERRED QUALIFICATIONS
- •Experience with eCOA/ePRO, devices, laboratory, registry, or third-party clinical data
- •Experience with Data Transfer Agreements, Data Transfer Specifications, UAT, validation artifacts, and vendor integrations
- •Knowledge of SDTM mappings and clinical data transfer technologies
- •Experience with project forecasting, resource planning, audits, or business development activities
REQUIRED VERIFIED SKILLS
COMPENSATION & REWARDS
ORGANIZATION CONTEXT & CULTURE
Thermo Fisher Scientific is a global life sciences company providing scientific products, services, and solutions that support pharmaceutical development, clinical research, diagnostics, and laboratory operations. Its PPD clinical research organization supports clinical development programs worldwide.
EXPECTED CAREER ROADMAP
APPLICATION ADVISORY
READY TO SUBMIT?
Verify your capability profile and matching credentials before submitting direct applications.
