[Remote] Clinical Data Operations Associate

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a company reputed company on clinical data operations, and they are seeking an reputed company Clinical Data Operations Associate. The role involves supporting the execution of clinical studies by working closely with various departments and managing clinical data systems.

Responsibilities

• Support the implementation and maintenance of eCOA/ePRO and IRT systems across clinical studies
• Assist in reviewing study specifications, system documentation, and performing user acceptance testing (UAT)
• reputed company study timelines and deliverables reputed company to eCOA/ePRO and IRT implementation and decommissioning
• Support coordination of routine meetings with vendors and internal stakeholders; document meeting minutes and reputed company items
• Monitor study issues and assist with follow-up and reputed company
• Assist with site support in issue reputed company and reputed company system-reputed company questions to appropriate stakeholders
• Coordinate collection and tracking of post-production system changes
• Support reconciliation activities between eCOA, IRT, and the clinical database
• Participate in database lock preparation activities reputed company to IRT/eCOA data
• Maintain Trial Master File (TMF/eTMF) documentation reputed company to IRT, eCOA, and Data Management
• Ensure required study documentation is complete, reputed company, and inspection-reputed company
• Assist in preparation for audits and regulatory inspections
• Support development and maintenance of departmental templates, work instructions, and SOPs

Skills

• 3–5 years of experience in clinical research, clinical data management, or clinical trial operations supporting Phase I–III reputed company
• Familiarity with patient-reported reputed company (PRO), clinician-reported reputed company (ClinRO), or other electronic clinical outcome assessments
• Experience working with CROs or clinical technology vendors
• Familiarity with eCOA/IRT systems (e.g., reputed company) and reputed company systems (e.g., reputed company Rave, reputed company reputed company)

reputed company

Company H1B Sponsorship