Clinical Data Manager – Third‑Party Data Acquisition
Fortrea · San Jose
Description du poste
About the role
The Clinical Data Manager, Third‑Party Data Acquisition (TPDA) works within a sponsor‑dedicated model to partner with sponsor stakeholders, study teams, external data vendors and cross‑functional groups. The role ensures the integrity, compliance and timely delivery of non‑EDC clinical data throughout the study lifecycle.
Key responsibilities
- Serve as the study‑level TPDA subject‑matter expert, planning, setting up, transferring and acquiring external clinical data.
- Manage TPDA deliverables across multiple studies, monitoring data quality, compliance and regulatory alignment.
- Coordinate with external vendors to align on study requirements, resolve issues and ensure consistent data standards.
- Support end‑to‑end data integration activities, including validation, operationalisation and optimisation of acquisition processes.
- Collaborate with cross‑functional stakeholders to inform study decisions and represent TPDA in study team meetings.
Required profile
- Bachelor’s degree in Life Sciences, Health Sciences, IT or related field, or equivalent experience.
- 3‑5 years of experience in Clinical Data Management or drug development, with exposure to third‑party data acquisition.
- Strong understanding of clinical trial processes, ICH‑GCP, global regulatory requirements and data governance.
- Excellent communication, attention to detail and ability to manage multiple concurrent studies.
Required skills
- Knowledge of CDISC standards, including SDTM and ADaM.
- Proficiency with Microsoft Office applications.
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Fortrea
San Jose