PERM ROLE can be work from home / Remote with occasional onsite visits in North NJ - New Jersey - with our direct PHARMACEUTICAL client
- Lead the conduct of internal clinical System/Process audits and Data Integrity & Access Governance (DIAG) audits as needed.
* Lead the conduct of clinical vendor audits of CROs, laboratories, and other providers to clinical trials by conducting remote audits or on-site audits (as deemed necessary) in the Americas, following company procedures and practices, to verify data integrity, GCP compliance with ICH guidelines and government regulations/guidance.
- Support health authority inspections and preparation activities related to IT aspects
- Compile and analyze audit metrics to communicate trends to business group
- Bachelor’s degree in associated functional disciplines including IT, Data Sciences, Pharmaceutical Science and others
* 8+ years of pharmaceutical company experience preferably in Clinical data management, Clinical Systems or related area.
* Minimum of 3-6 years of Quality Assurance auditing experience with at least 2 years conducting Systems and clinical vendor audits
- Experience with inspection management including leading inspection strategy
- Knowledge of general GCP, clinical trial methodology, and specific knowledge of applicable regulations/guidance (including 21 CFR Part 11) and ICH Guidelines related to clinical computer systems
* Clinical systems orientation with familiarity of emerging technologies such as cloud computing, mobility, and big data and its applicability to clinical research
- Strong analytical skills and report writing skills
Job Type: Full-time
Salary: $0.00 /year
- Pharmaceutical & Quality Assurance Auditing: 8 years (Required)