Quality Clinical Operations Leader
hace 2 semanas
As a Quality Clinical Operations Leader you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
You will be dedicated resource to one of our clients, be embedded in their working environment, systems and processes. You will be engaged in a wide range of interesting and challenging tasks including to assess current status of Clinical Trial’s Inspection Readiness preparations, execute Inspection readiness Preparation activities as directed by the Quality Clinical Trial Manager and provide ongoing support during the pre, during and post inspection readiness phases.
**What you will be doing**:
- Consult on and execute strategy on the Inspection Readiness Support Plan with the Study CTM, Asset Lead, QA Rep and Dev Ops Quality Sr. Director or designee
- Identify areas driven by the Study Clinical Operations Leader that may need additional resource support
- Coordination with Study COL’s to ensure Study Teams and Vendors are adhering to Study Plans
- Perform a Study Plan Gap Analysis
- Lead Liaison with Vendors to ensure compliance to IR activities
- Lead Liaison support to Study COL for IP supply reconciliation
- Assist QA in prepping key sites for inspections and attaining requested documents from inspectors as directed.
- Supporting QA in IR team meetings
- Maintains training on up to date regulations and IR best practices
- Support of DOQ and supporting departments teams during lulls in inspection
- Ensures adherence to GCP and all applicable local and internal regulations
- Maintains IR Sharepoint Site with relevant materials as directed by the Quality CTM
- May be assigned Quality Clinical Trial Manager responsibilities, with oversight, as a development opportunity
**You Are**:
- BS/BA degree or a relevant degree with strong emphasis on science; Minimum of five years of experience in the biopharmaceutical industry or other relevant clinical research experience in the conduct and management of multinational clinical trials
- Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health authority experience
- Extensive experience in Inspection Preparation/Inspection participation
- Experience in all phases of a clinical trial lifecycle from initiation to clinical study report
**Why ICON**:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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