Associate Director, Clinical Quality Assurance - Systems & Data Integrity

Alternative Resources Company

Associate Director, Clinical Quality Assurance - Systems & Data Integrity

Associate Director, Clinical Quality Assurance – Systems & Data Integrity
 
The Associate Director, GCP Quality Assurance Systems & Data Integrity, will oversee quality oversight activities of Clinical trial Systems used by the company, Vendors & CROs and lead associated audits and inspection management. This person will manage cross-functional relationships with internal and external stakeholders and be the Lead Quality Assurance representative to IT and associated vendor management. This is a high visibility position with great impact potential.
 
Responsibilities
  • 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
 
Qualifications
  • Bachelor’s degree in associated functional disciplines including IT, Data Sciences, Pharmaceutical Science and others
  • Approximately 5 to 8 years of pharmaceutical company experience preferably in Clinical data management, Clinical Systems or related area.
  • Minimum of 3-5 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
  • Ability to demonstrate tact as a representative of the CQA Department
  • Must have professional communications skills, strong independent time management skills and the ability to manage multiple projects concurrently
  • Ability to Travel (approximately 20%)