Clinical Data Operations Associate
Job Summary
Supporting clinical development programs, the remote Clinical Assessment Data Operations Associate will manage the implementation and maintenance of clinical assessment technologies, coordinate operational activities, track study deliverables, and ensure compliance with regulatory requirements.
Key Responsibilities
- Support the implementation and maintenance of eCOA/ePRO and IRT systems across clinical studies
- Serve as an operational contact for eCOA/ePRO and IRT vendors, tracking deliverables and project milestones
- Maintain Trial Master File (TMF/eTMF) documentation and assist in preparation for audits and regulatory inspections
Required Qualifications
- Bachelor's degree in Life Sciences, Computer Science, Health Sciences, or a related field
- 2-5 years of experience in clinical research, clinical data management, or clinical trial operations
- Familiarity with patient-reported outcomes (PRO) and electronic clinical outcome assessments
- Experience with eCOA/IRT systems and EDC systems
- Working knowledge of GCP, ICH guidelines, and clinical trial processes
Complete Job Description
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