Manager, Clinical Quality

JOB DESCRIPTION—

CLINICAL Quality, Manager

  • Job Description Summary

Responsible for ensuring planning and leading clinical quality activities such as audits of clinical studies and clinical trials conducted by Cardinal Health and other organizations contracted by Cardinal Health. The position will provide direction to clinical project teams and assess compliance with company standard operating procedures, regulations, guidelines, and clinical study protocols. This is a cross functional position that works with Cordis personnel in other departments, particularly Clinical, in a collaborative nature on various quality topics. Works on most assignments with instructions about the general results expected. May receive technical guidance on the most unusual or complex problems, but independently determines and develops approaches to solutions. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Erroneous decisions or recommendations or failure to get results would normally result in serious compliance and regulatory risks to the company.

Job Description

What Quality & Regulatory Audit contributes to Cardinal Health

  • Responsible for independent (with supervisory assistance or interdepartmental collaboration as needed) planning, scheduling, and conducting Clinical QA inspections/audits/reviews to assure compliance with regulatory requirements and adherence to corporate policies, and internal standards/requirements.
  • Applies intensive and diversified knowledge of pre-clinical, clinical trials, and clinical quality principles and practices in broad areas of assignments and related fields.
  • Makes decisions independently on clinical quality problems and methods, and represents the organization in meetings to resolve important questions and to plan and coordinate work.
  • Requires the use of advanced techniques and the modification and extension of theories, precepts and practices of his/her field and related sciences and disciplines.
  • Supervision and guidance related largely to overall requirements, critical issues, new concepts, and policy matters.
  • Consults with supervisor concerning unusual problems and developments.
  • Provides expert guidance to meet international medical device and combination devices regulatory requirements.

  • Responsible for the following:
  • Plans, develops, coordinates, and directs clinical quality activities for a large important clinical trial project or a number of small projects with many complex features.
  • As an individual contributor, carries out complex or novel assignments requiring the development of new or improved techniques or procedures.
  • Work is expected to result in the development of new or improved techniques or procedures.
  • Work is expected to result in the development of new or refined materials, processes, and/or methods.
  • Develops and evaluates plans and criteria for a variety of projects and activities to be carried out by others.
  • Assesses the feasibility and soundness of proposed clinical studies.
  • Performs as a Lead Auditor to facilitate and manage company pre-clinical and clinical quality audit programs, including but not limited to, audits of the clinical research department, audits of clinical trial program suppliers, Principal Investigators, animal laboratories, Contract Research Organizations, and software providers.
  • Facilitates and manages external and internal inspections as they are related to the company Clinical and Pre-Clinical programs. May perform as a scribe, back room manager, request administrator or other critical roles in an inspection.
  • Serves as clinical quality compliance lead for the company and ensures department metrics are monitored to ensure goals are met. Manages company Pre-Clinical/Clinical  Quality programs.
  • Performs as a staff consultant on a technical specialty, a type of facility or equipment, or a program function.
  • Practices company safety and quality policies and procedures.
  • Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
  • Responds to compliance inquiries from the applicable peer department with supervisory assistance as needed.
  • Keeps abreast of new regulations/requirements through active review of current compliance-based literature.
  • Responsible for communicating business related issues or opportunities to next management level.
  • Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.
  • Responsible for ensuring personal and Company compliance with all applicable International, Federal, State, local and Company regulations, policies, and procedures.
  • Performs other duties assigned as needed.

EDUCATION/TRAINING and/or EXPERIENCE:

  • BS degree in relevant discipline and four or more years of related pre-clinical, clinical, clinical quality, clinical affairs, quality compliance or quality systems experience; or,
  • MS in relevant discipline and three or more years of related pre-clinical, clinical, clinical quality, clinical affairs, quality compliance or quality systems experience; or,
  • Has significant complex level clinical quality, clinical affairs, pre-clinical or clinical experience.
  • Must possess at least five years’ experience within the medical product industry, preferably medical or combination devices.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES:

  • Must possess significant level of knowledge regarding global medical device regulations (CMDCAS, 21CFR Part 820, RDC, JPAL, MDD, ISO 13485) and global clinical trial regulations (Declaration of Helsinki, 21CFR Parts 11, 50, 56, 58, 312, 812, 45 CFR Part 46, ICH GCP-E6, ICH–E2A).
  • Must effective in English communication skills, both written and oral.
  • Lead Auditor Certification or training is highly desired.
  • ASQ certifications in auditing and/or biomedical auditing is highly desired
  • Certification as a Clinical Research Associate (CRA) is highly desired.