Job Details: Manager, Clinical Compliance - Clinical Operations
Vacancy Name: Manager, Clinical Compliance - Clinical Operations
Vacancy No: VN514
Employment Type: Full Time
Location of role: Conshohocken, PA or Gaithersburg, MD
Department: Clinical Operations
Key Responsibilities:
- The Manager, Clinical Compliance is responsible for the management and execution of activities associated with inspection preparedness, inspection support, clinical procedural development and maintenance, clinical training programs, and assessment and investigation of clinical quality compliance issues.
- 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 and functions in being inspection ready.
- Provide ongoing inspection readiness support and expertise to study teams, including risk mitigation and monitoring.
- Execute plans with clinical teams and cross-functionally to prepare for audits and regulatory agency inspections.
- Provide representation for the Clinical Compliance function in Sponsor audits and Regulatory Agency inspections, and supervise Clinical preparation room activities.
- Coordinate follow-up within the Clinical organization on all audits, inspection responses, commitments, post-inspection activities, and implementation of corrective and preventive actions (CAPA).
- 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 and systems including Policies, SOPs, Work Instructions, forms and templates in compliance with global regulatory standards.
- Lead the strategy execution for role-based curriculum and GCP training within the Clinical organization.
- Collaborate with QA with the preparation/collection of all training documents in preparation for internal training file audit.
- Assist with oversight and/or conduct compliance assessments including vendor/contractor qualification assessments in collaboration with Quality Assurance.
- Assist with management and oversight of the tracking of Suspected Serious Clinical Non-Compliance Issues (SSCNCI).
- Support the completion of internal audit reports and collaborate with the Quality function(s) to assess process improvement and/or training needs and opportunities.
- Track status of open Quality Issues and CAPAs and coordinate with Clinical stakeholders to ensure timely and adequate closure.
- Generate, report, and respond accordingly to compliance/inspection readiness KPIs.
Other Duties:
- Support and prepare internal and external clinical operations teams for audits.
- Provide training on Clinical Standard Operating Procedures and Work Instructions to ensure compliance with regulatory organizations.
- Support and manage in collaboration with Quality Assurance the clinical quality database observations.
- Identify opportunities and provide leadership in continuous improvement of good clinical practices.
- Establish and assure adherence to budgets, schedules, work plans, and performance requirements.
- Regularly communicate with senior management or executive levels on matters regarding several functional areas.
Experience & Knowledge:
Essential:
- At least 8 years relevant experience in a biotechnology/pharmaceutical industry and/or contract research organization (CRO) with experience in compliance, quality, training or related clinical operations function.
- Expertise in global regulatory and compliance requirements for clinical research.
- Ensure an enthusiastic and open attitude towards continuous professional development.
- Experience with the following skill set:
- Performing PAI and Inspection readiness assessments.
- Making high level presentations.
- Delivering open and honest constructive feedback.
- Taking responsibility and ownership for entrusted tasks.
- Being flexible to new ideas and approaches.
- Handling disjointed tasks effectively.
- Being able to work productively with others.
- Accomplishing goals under project timelines.
Desirable:
- Prior experience with clinical auditing and relevant clinical operations functions.
- Compliance and training experience.
Education & Qualifications:
- BA / BS or higher in a science-related field.
- 8+ years’ experience in related area with some experience in QA/Audit setting preferred.
- Clinical Operations and/or Inspection Readiness experience preferred.
- Demonstrated computer skills; proven functional knowledge of Microsoft packages.
Some international and local travel may be required. Approximately up to 20% travel.
About the Company:
Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize transformative medicines addressing unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognized as some of the biotech industry’s most successful drug developers.
At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives and transformative changes happen.
Immunocore is proud to be an equal opportunity employer, committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered.
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