Clinical Quality Compliance Lead

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0-2 years

Not Disclosed

Remote, USA

10 Oct. 6, 2025

Job Description

Job Type: Full Time Remote Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

🧭 Position Overview

Role: Clinical Quality Compliance Lead
Employer: ICON Strategic Solutions
Location: United States (Homeworking)
Contract Type: Permanent | Full Time
Discipline: Clinical Research / Quality
Experience Level: Experienced (Non-manager)
Start Date: 3 Oct 2025
Closing Date: 2 Nov 2025
Salary: Competitive

Join the world’s largest and most comprehensive clinical research organisation powered by healthcare intelligence.

🎯 Key Responsibilities

🔹 Risk Management & Quality Planning

Participate in all study activities and assess key risks in clinical protocols.
Advise clinical teams on effective mitigation strategies.
Review risk areas with Risk Owners to monitor mitigation progress and identify new risks.
Maintain Integrated Quality Plans (IQP) in quality risk repository for regular updates.
Collaborate with Risk Owners to evaluate mitigation actions and perform effectiveness checks.
Report risk updates to R&D Business Partners via cross-functional meetings or Quality Working Groups.
Escalate new central or systemic risk concerns to management for resolution.

🔹 Issue Management & Compliance Assessment

Ensure consistent interpretation of issues requiring quality investigations.
Provide guidance on Significant Quality Issues (SQI) per corporate standards and escalate to senior R&D management.
Conduct initial serious breach evaluations for regulatory reporting.
Collaborate with BRQC partners to develop CAPA (Corrective & Preventive Action) Plans and conduct Effectiveness Checks.

🔹 Submission & Inspection Support

Support Pre-submission Quality Stage Gate Reviews (SGR) and follow-up activities.
Lead proactive inspection readiness across study phases.
Assist trial teams with oversight, documentation, and mock inspections.
Provide back-room and post-inspection support for Sponsor-Monitor and third-party inspections (vendors, CROs, co-development partners).
Offer remote inspection support for investigational sites.

🔹 Consultancy & Advisory

Provide independent quality and compliance advice to Business Partners.
Collaborate with Quality Professionals and SMEs to ensure consistent regulatory interpretation.

🔹 Post-Licensing, Acquisition & Integration

Support quality integration of acquired assets or companies (90-day plan).
Deliver robust documentation and execute assigned integration activities.
Offer guidance for asset divestments and general quality-related advice.

🎓 Qualifications & Skills

✅ Required

Bachelor’s degree (Scientific, Medical, or related discipline).
Proficiency in Microsoft Office.
Fluent in spoken and written English.
Strong interpersonal, oral, and written communication skills.
Experience in GCP Quality and/or Clinical Trials.
Proven collaboration in cross-functional environments.
Flexibility to adapt to changing business needs.
Ability to operate in diverse cultural and business settings.

⭐ Preferred

Knowledge of GMP, GLP, and GPvP.
Specific Therapeutic Area experience (as required).
Global clinical trial risk management experience.
Background in Quality Management, QA/QC, or Compliance.
Familiarity with ICH Guidelines.
Experience with Health Authority Inspections (FDA, EMA, etc.).
Strong Project Planning & Management skills.
Proficiency with Data Analytics/Visualization Tools (Tableau, Spotfire).
Ability to analyze and interpret data for decision-making.
Skilled in managing escalations and CAPA advisement.

💡 What ICON Offers

ICON prioritizes a diverse, high-performance culture and nurtures talent through competitive benefits focused on well-being and work-life balance.

🌿 Benefits Include:

Generous annual leave entitlements
Various health insurance plans for employees and families
Retirement planning options
Global Employee Assistance Programme (TELUS Health) — 24/7 professional support
Life assurance coverage
Flexible country-specific benefits, e.g.
- Childcare vouchers
- Bike purchase schemes
- Gym membership discounts
- Subsidized travel passes
- Health assessments

🔗 More Info: ICON Careers Benefits

🌍 Diversity, Inclusion & Accessibility

ICON fosters an inclusive and accessible environment, free from discrimination.
All qualified applicants will receive equal consideration regardless of race, gender, orientation, disability, or veteran status.
📩 If you need a reasonable accommodation during the application process, use this form:
Request Accommodation

🤝 Encouragement

Not sure you meet every requirement? Apply anyway! You might be exactly what ICON needs — either for this position or another opportunity.

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Clinical Quality Compliance Lead

Job Description

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