Tasks

- Provides quality and compliance guidance to Clinical Operations personnel
- Collaborates with medical and clinical quality compliance group
- Develops and/or delivers GCP and compliance training
- Leads or supports the development of a GCP inspection readiness programme at a local and/or global level
- Facilitate GCP audits of vendors, sites and TMF and ensure findings are fed back into the GCP inspection readiness programme or appropriate training or processes
- Proposes, develops or supports the development and implementation of internal GCP compliance process improvement strategies, tools, initiatives or workstreams
- Stays abreast of new and revised government, industry and company regulations, trends and interpretations by participating in trainings, conferences, workshops and discussion groups as appropriate
- Liaises with co-monitors and global/regional leads to provide input into quality oversight visit planning
- Gives input on goals for regional study teams to ensure inspection readiness
- May provide input to key clinical documents, including but not limited to protocols, investigator brochures, informed consent forms and clinical study reports

Qualifications

- Bachelor’s degree (or equivalent) or higher in a scientific, medical or healthcare discipline
- Minimum of 3-5 years of experience in clinical compliance or operations (manager)
- Excellent GCP knowledge