Manager, Clinical Compliance - Clinical Operations

Immunocore - Conshohocken, PA

Full-time - Mid Level

Conshohocken, PA

Professional, Scientific, and Technical Services

About the position

The Manager, Clinical Compliance is responsible for overseeing inspection preparedness, support, and the development and maintenance of clinical procedures and training programs. This role ensures compliance with regulatory standards and drives continuous improvement in clinical quality compliance within the Clinical Operations department.

Responsibilities

• Lead the development and delivery of GCP and Inspection Readiness training for the Clinical organization
• Lead the development and implementation of processes and tools to support teams in being inspection ready
• Provide ongoing inspection readiness support and expertise to study teams, including risk mitigation and monitoring
• Execute plans with clinical teams to prepare for audits and regulatory agency inspections
• Provide representation for the Clinical Compliance function in Sponsor audits and Regulatory Agency inspections
• Coordinate follow-up on all audits, inspection responses, commitments, and implementation of corrective actions
• Generate, analyze and communicate inspection readiness metrics
• Drive continuous improvement into inspection readiness and inspection conduct support
• Lead the development and approval of controlled documents related to clinical study processes
• Collaborate with QA in preparation for internal training file audits
• Assist with compliance assessments including vendor/contractor qualification assessments
• Manage tracking of Suspected Serious Clinical Non-Compliance Issues (SSCNCI)
• Support the completion of internal audit reports and assess process improvement needs
• Track status of open Quality Issues and CAPAs and coordinate with stakeholders for closure
• Generate, report, and respond to compliance/inspection readiness KPIs

Requirements

• At least 8 years relevant experience in biotechnology/pharmaceutical industry or CRO
• Expertise in global regulatory and compliance requirements for clinical research
• Experience performing PAI and Inspection readiness assessments
• Strong presentation skills, both orally and in writing
• Ability to deliver constructive feedback and take ownership of tasks
• Flexibility to adapt to new ideas and changes in plans
• Ability to work collaboratively in a multi-disciplinary team
• Proven ability to accomplish goals under project timelines
• BA/BS or higher in a science-related field

Nice-to-haves

• Prior experience with clinical auditing and relevant clinical operations functions
• Experience in compliance and training
• Some experience in QA/Audit setting preferred
• Clinical Operations and/or Inspection Readiness experience preferred

Benefits

• Health insurance
• 401k plan
• Paid holidays
• Professional development opportunities
• Flexible scheduling