Senior Clinical Operations & Compliance Lead

Unicon Pharma Inc; Redwood City (CA); On-site; USD 140,000 - 180,000; Full time

Job summary

Unicon Pharma Inc. in Redwood City, CA is seeking a Clinical Program Manager to lead Clinical Operations Excellence efforts across studies. You will enhance processes, drive inspection readiness, and partner with QA, Compliance, and cross-functional teams to ensure study integrity.

The role requires 8+ years of experience in Clinical Operations or Trial Management and a Bachelor’s degree or RN. You will oversee SOPs, CRO/vendor oversight, risk management, and mentoring of the Clinical Operations

Qualifications

• Experience in clinical operations and trial management.
• Lead quality and inspection-readiness initiatives.
• Experience with CRO/vendor oversight.

Responsibilities

• Develop and maintain Clinical SOPs, processes, and study tools.
• Drive inspection readiness, quality, and process improvement.
• Manage CRO/vendor and monitoring oversight.
• Support RFPs and CRO/vendor selection.
• Develop clinical trial tracking, reporting, and oversight processes.
• Conduct risk assessment, contingency planning, and remediation.
• Train and mentor Clinical Operations team members.
• Collaborate with Clinical Operations, CQA, Compliance, and cross-functional teams.

Skills

Clinical Operations / Clinical Trial |

Education

Bachelor's degree or RN

Job description

Unicon Pharma Inc. in Redwood City, CA is seeking a Clinical Program Manager to lead Clinical Operations Excellence efforts across studies. You will enhance processes, drive inspection readiness, and partner with QA, Compliance, and cross-functional teams to ensure study integrity.

The role requires 8+ years of experience in Clinical Operations or Trial Management and a Bachelor’s degree or RN. You will oversee SOPs, CRO/vendor oversight, risk management, and mentoring of the Clinical Operations