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          Associate Director, Clinical Quality Assurance, Systems & Data Integrity

          Affinity Executive Search
          Woodcliff Lake, NJ 07677
          Full-time, Part-time
          Refer friends, get paid!

          Job Description

          Associate Director, Clinical Quality Assurance, Systems & Data Integrity Not right for you? We've got others

          Salary: $150,000 - $165,000 Location: Woodcliff Lake, New Jersey Posted: July 17th 2020 Minimum Degree: Bachelor Relocation Assistance: Available

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          Our client is a premier, nationally recognized Pharmaceutical company looking to hire a Associate Director, Clinical Quality Assurance, Systems & Data Integrity.

          Essential Functions

          • 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

          The pharmaceutical industry is NJ's top industry and recession-proof. Very stable environment.

          Requirements:

          • 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
          • 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
          Posting ID: 566875416Posted: 2020-08-09