Manager, Clinical Compliance

The Manager, Clinical Compliance role 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.

Key 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 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, including support of ongoing storyboarding
• 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 (e.g., completed SOP matrices, CVs, JDs etc.)
• Assist with oversight and/or conduct compliance assessments including but not limited to 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), including reporting (if applicable) and ensure follow-up and closure
• Support the completion of internal audit reports and collaborate with the Quality function(s) to assess process improvement and/or training needs and opportunities.
• Manage follow-up within the Clinical organization on all audits, inspection responses, commitments, post-inspection activities, and implementation of corrective and preventive actions (CAPA)
• Track status of open Quality Issues and CAPAs and coordinate with Clinical stakeholders to ensure timely and adequate closure, as appropriate
• Generate, report, and respond accordingly to compliance/inspection readiness KPIs
  
  

Other Responsibilities

• 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, relative to inspection readiness support and clinical compliance activities..
• Regularly communicate with senior management or executive levels on matters regarding several functional areas
  
  

Essential Qualifications

Education, Experience and Knowledge:

• BA / BS. or higher in science related field (biological science, medical, pharmacy or other health related discipline)
• Clinical Operations and/or Inspection Readiness experience preferred
• Demonstrated computer skills; proven functional knowledge of Microsoft packages (MS Word, Excel, Power Point, Outlook, MS Project, SharePoint)
• 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, including but not limited to US CFR, EUCTD, and ICH GCP.

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, both orally and in writing using organizational skills to complement this
• Delivering open and honest constructive (positive and/or negative) feedback pertaining to work in hand
• Taking responsibility and ownership for entrusted tasks; seeing tasks through to completion and dealing with the consequences of failure or success.
• Being flexible to new ideas and approaches; changes of plans, objectives and/or priorities. Handling disjointed tasks effectively. in a highly collaborative, multi-disciplinary team setting.
• Being able to work productively with others to achieve tasks while showing consideration for the needs and feelings of others.
• Accomplishing goals under project timelines.