Clinical Operations Learning

3 weeks ago


London, United Kingdom Parkside Office Professional Full time

My client are a global-based biopharmaceutical company. They are seeking an expereinced Clinical Operations Learning & Development lead to join their team.

The Clinical Operations Learning & Development Lead will own the development, delivery, and continuous improvement of training and development programs within the Clinical Operations organization.

You will manage the 'Foundations of Clinical Monitoring' program to develop key knowledge, skills and abilities in clinical monitoring, study & sight management, vendor oversight, regulatory compliance and inspection readiness.

Core Responsibilities Include:

- Own and manage internal foundations clinical monitoring development program responsible for hosting three cohorts per year
- Design, develop and deliver in-person instructor led training and virtual training in support of learning & development programs
- Monitor external environment, regulatory/process, ICH/GCP changes impacting ClinOps Practices and ensures required changes are implemented
- Facilitates ongoing quality improvement and inspection readiness mindset through inspection results, audits and CAPAs for development of case studies, lessons learned and other training materials
- Develops, facilitates and executes an interactive mock site visit scenario for program participants which includes all materials, planning and support coordination
- Leads and supports process improvement initiatives with the goal of 2 program enhancements per cohort
- Provide GCP and monitoring related consultation

Qualifications:

- BA/BS degree; graduate degree a plus
- 5+ years' experience field monitoring experience (performing on-site monitoring of clinical trials, conducting SIVs, IMVs, and COVs for IND regulated clinical research studies) as a clinical trial monitor/clinical research associate (CRA)
- Excellent knowledge of the drug development process, specifically clinical trials/research
- Knowledge of international standards (GCP/ICH, FDA, EMEA) and ethics/IRB approval process

Parkside Recruitment Ltd is acting as an Employment Business in relation to this vacancy. Parkside Recruitment is an Equal Opportunities Employer.


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