Prominent vaccine company looking to hire a Senior Manager of Clinical Investigator Site Audits. Complete with a competitive package, this is an opportunity you do not want to miss!
- Prepare and execute risk-based Investigator Site Audit program.
- Plan, organize and lead audits of clinical investigator sites for compliance to protocols,
policies, SOPs, and applicable regulations.
- Review corrective and preventive action plans/audit responses for adequacy.
- Interpret, explain, and apply the applicable GCP current regulations, guidelines,
policies, and procedures for GCP site audits, support of clinical teams, escalating and supporting processing of potential quality issues, escalations, and potential serious breaches.
- Quality review of clinical documentation, such as protocols, informed consent forms and Investigators Brochures, according to applicable sponsor procedures and applicable regulations.
- Review and evaluate the potential risk of compliance and quality issues;
Provide QA support to, and interact with, internal functions, service providers and
CROs on issue management and escalation process.
- Assist CQA management in the development, revision and implementation of QA and cross functional strategic processes, procedures, and work practices to ensure continuous quality improvement.
Requirements and Experience:
- Bachelor's Degree or equivalent in a Life Science, nursing or pharmacy is preferred.
- 5+ years' experience in global GCP Regulations and guidance.
- 3+ years of leading and conducting GCP audits on Clinical Investigator Sites (must).
- Experience with Trackwise, Veeva or Master Control eQMS in the various modules, audit, CAPA and Deviations etc.
- Travel required - 30% (Domestic and International)