Manager, Clinical Compliance - Clinical Operations

Hiring By - Biostaffic

 BioPharma

Job Highlights

Not Disclosed

Mid-Senior level

Posted 4 months ago
Job details
Location of role Rockville, Conshohocken
About the Company Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry’s most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.
Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.
We strive to create a diverse and inclusive workplace, while seeking talented individuals to work with us across the many functions that will allow us to deliver new medicines to transform the lives of patients. You will work with outstanding people who together pioneer the research, development and commercialization of bi-specific TCR therapies. We aim to create an environment where individual contributions and initiatives can be maximized, while fostering a culture of collaboration, based on respect and integrity. We want each individual employee to own their career, as part of high-performing teams, and in the context of on-the-job and formal continuous development and training, as well as constructive feedback. We always strive to identify ways to improve what we do and how we do it, by asking questions, voicing opinions, exploring various approaches and staying connected with healthcare professionals, patients, academia and other key partners.
Key Responsibilities The Manager, Clinical Compliance role is responsible for the management and execution of activities associated with clinical procedural development and maintenance, clinical training programs, inspection preparedness, and assessment and investigation of clinical quality compliance issues. This position may also support management and execution of clinical vendor qualification assessments working in collaboration with quality assurance.
Key Responsibilities
  • Lead the development and approval of controlled documents related to clinical study processes and systems in 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
  • Lead the development and delivery of GCP and Inspection Readiness training for the Clinical organization
  • Work with functional teams to create process flows and develop previously unwritten work instructions and/or development of New SOPs
  • 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.
  • 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
  • Manage follow-up within the Clinical organization on all audits, inspection responses, commitments, post-inspection activities, and implementation of corrective and preventive actions (CAPA)
  • Support and prepare internal and external clinical operations teams for audits
  • Direct and train on Clinical Standard Operating Procedures and Clinical Operating Procedures to ensure compliance with regulatory organizations.
  • Support and manage in collaboration with Quality Assurance the clinical quality database observations
  • Organize pre- and post-study document reviews and takes corrective action.
  • Provide leadership in continuous improvement of good clinical practices.
  • Monitor audit reports to clinical management.
  • Select, develop and evaluate personnel to ensure the efficient operation of the function.
  • Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives. Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results.
  • Establish and assure adherence to budgets, schedules, work plans, and performance requirements.
  • Regularly interact with senior management or executive levels on matters concerning several functional areas
SUPERVISORY RESPONSIBILITY
  • Provide direction and support to direct report(s) to ensure consistent approach and processes
  • Provides support/escalation point for direct reports as needed
Experience & knowledge
Essential
  • At least 7 years relevant experience in a biotechnology/pharmaceutical industry and/or clinical research o organization 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
  • Presenting 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.
Desirable
Prior experience with the following would be an advantage
  • Clinical auditing and relevant clinical operations functions
  • Compliance and training
Education & Qualifications
  • BA / BS. or higher in science related field (biological science, medical, pharmacy or other health related discipline)
  • 10+ years’ experience in related area with experience in QA/Audit setting or Additional Eligibility Qualifications
  • Clinical Operations functional background
  • Demonstrated computer skills; proven functional knowledge of Microsoft packages (MS Word, Excel, Power Point, Outlook, MS Project, SharePoint)
Some international and local travel maybe required. Approximately up to 20 % travel.

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

Experience:

  • Mid-Senior level

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 11, 2024
Company Overview
Immunocore
Immunocore

Current Openings: 0

Immunocore is a leading T cell receptor (TCR) biotechnology company working to create first-in-class biological therapies to address unmet patient needs in oncology as well as infectious and autoimmune diseases. See our community guidelines: http://bit.ly/2kFA8hr
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