Clinical Assessment Data Operations Associate

This is a fully remote position, open to applicants in California, +1 more state.

📋 Description

• Assist in planning, executing, and maintaining eCOA/ePRO and IRT systems within clinical development initiatives.

• Oversee daily operational tasks and monitor study deliverables.

• Examine study specifications and system documentation while conducting user acceptance testing.

• Manage study timelines and deliverables associated with system implementation and decommissioning.

• Organize regular vendor and stakeholder meetings, documenting minutes and action points.

• Track study-related issues and aid in their resolution.

• Act as the main operational liaison for eCOA/ePRO and IRT vendors.

• Monitor vendor deliverables, documentation, and project milestones.

• Aid in licensing processes and study-specific documentation.

• Prepare for governance meetings by gathering metrics and reviewing presentation materials.

• Assist in resolving site issues and direct system-related inquiries.

• Coordinate adjustments to the system post-production.

• Facilitate reconciliation between eCOA, IRT, and the clinical database.

• Engage in database lock preparation related to IRT/eCOA data.

• Maintain TMF/eTMF documentation, ensuring it is ready for inspection.

• Support audits and regulatory inspections.

• Assist with departmental templates, work instructions, and SOPs.

• Collaborate with Clinical Data Management, Biostatistics, Clinical Operations, Medical, Regulatory, Outsourcing, Programming, and external vendors.

• Participate in study team meetings, providing operational updates.

• Contribute to process enhancement and lessons learned initiatives.

⛳️ Requirements

• Bachelor's degree, ideally in Life Sciences, Computer Science, Health Sciences, or a related discipline.

• 2–5 years of experience in clinical research, clinical data management, or clinical trial operations supporting Phase I–III clinical trials.

• Understanding of patient-reported outcomes, clinician-reported outcomes, or other electronic clinical outcome assessments.

• Experience collaborating with CROs or clinical technology vendors.

• Familiarity with eCOA/IRT systems, such as Suvoda.

• Knowledge of EDC systems, including Medidata Rave and Veeva CDMS.

• Proficient in Microsoft Office Suite, encompassing Excel, Word, PowerPoint, and Teams.

• Strong organizational and project coordination abilities.

• Capability to manage multiple priorities in a dynamic environment.

• Exceptional written and verbal communication skills.

• Strong interpersonal and collaboration abilities.

• Ability to work independently while appropriately escalating issues.

• Working knowledge of GCP, ICH guidelines, and clinical trial protocols.

🏝️ Benefits

• Competitive base salary.

• Equity opportunities.

• Performance-related bonus potential.

• Comprehensive salary and benefits package.

• Supportive and inclusive team atmosphere.

• Opportunities for professional growth and advancement.

• Startup environment where your work can significantly influence the delivery of new medicines to patients.