Clinical Program Manager – Clinical Operations Excellence (CORE)

Unicon Pharma Inc; Redwood City (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Unicon Pharma Inc is seeking an experienced Clinical Operations Professional to join our Clinical Operations Excellence (CORE) team. This role will focus on clinical study quality, process improvement, inspection readiness, SOPs, and vendor/monitoring oversight across clinical trials.

You will develop and implement processes, collaborate across functions, manage risk, support vendor selections, and mentor the Clinical Operations team.

Qualifications

• RN or Bachelor’s degree in Biological Sciences, Health Sciences, or related field.
• 8+ years of Clinical Operations and/or Clinical Quality Assurance experience in pharma/biotech.
• Strong knowledge of GCP, ICH Guidelines, FDA and EMA regulations, and clinical SOPs.
• Proven experience developing clinical operations SOPs, processes, templates, or quality tools.
• Experience with clinical study, monitoring, and vendor oversight.
• Strong risk management, problem-solving, organizational, and cross-functional collaboration skills.
• Excellent written and verbal communication skills.
• Travel may be required (~25%).

Responsibilities

• Develop and implement clinical operations processes, SOPs, templates, and tools to support study quality and inspection readiness.
• Partner with Clinical Operations, Clinical Quality, CQA, and cross-functional teams on process improvement and quality initiatives.
• Develop and manage monitoring and vendor oversight processes.
• Support CRO/vendor selection, RFPs, vendor SOP reviews, and compliance activities.
• Lead risk management, contingency planning, and continuous improvement initiatives.
• Support clinical trial status tracking, reporting, and program-level planning.
• Train, mentor, and support Clinical Operations team members.
• Contribute to strategic initiatives and clinical operations excellence programs.

Skills

GCP & ICH FDA EMA

SOPs & quality tools

Vendor oversight

Risk management

Communication skills

Cross-functional collaboration

Travel readiness

Education

RN or Bachelor’s degree in Biological Sciences/Health Sciences/related field

Tools

MS Project

Smartsheet

Veeva Quality/QMS

eTMF/CTMS

Job description

We are looking for an experienced Clinical Operations Professional to join our Clinical Operations Excellence (CORE) team. This role will focus on clinical study quality, process improvement, inspection readiness, SOPs, and vendor/monitoring oversight across clinical trials.

Key Responsibilities

• Develop and implement clinical operations processes, SOPs, templates, and tools to support study quality and inspection readiness.
• Partner with Clinical Operations, Clinical Quality, CQA, and cross-functional teams on process improvement and quality initiatives.
• Develop and manage monitoring and vendor oversight processes.
• Support CRO/vendor selection, RFPs, vendor SOP reviews, and compliance activities.
• Lead risk management, contingency planning, and continuous improvement initiatives.
• Support clinical trial status tracking, reporting, and program-level planning.
• Train, mentor, and support Clinical Operations team members.
• Contribute to strategic initiatives and clinical operations excellence programs.

Required Qualifications

• RN or Bachelor's degree in Biological Sciences, Health Sciences, or related field.
• 8+ years of Clinical Operations and/or Clinical Quality Assurance experience in pharmaceutical or biotechnology organizations.
• Strong knowledge of GCP, ICH Guidelines, FDA and EMA regulations, and clinical SOPs.
• Proven experience developing clinical operations SOPs, processes, templates, or quality tools.
• Experience with clinical study, monitoring, and vendor oversight.
• Strong risk management, problem-solving, organizational, and cross-functional collaboration skills.
• Excellent written and verbal communication skills.
• Proficiency in Microsoft Office; MS Project/Smartsheet is a plus.
• Ability to work effectively in a fast-paced, collaborative environment.
• Travel may be required (~25%).

Preferred Qualifications

• Oncology clinical trial experience.
• Experience across study start-up, conduct, and close-out.
• On-site monitoring and risk-based monitoring experience.
• Ex-US clinical trial operations experience.
• Familiarity with eTMF, EDC, IRT, CTMS, Veeva Quality/QMS, or similar systems.