Manager, Clinical Operations - Quality

Position Summary

Responsible for managing the development and implementation of departmental quality assurance processes for the development, execution and reporting of clinical investigations by Global Clinical Operations (GCO). Responsibilities will include processes for GCO team member training, risk assessment, auditing, and regulatory monitoring. Responsible for review of SOPs, Work Instructions (WI) and Guidance Documents (GD) pertaining to clinical investigations to ensure compliance with current and revised FDA, GCP and geographical regulatory governing bodies regulations, and for supporting implementation through ongoing assessment of compliance to the requirements and development of actionable plans, as needed.

Principal Responsibilities

• Remain up to date on regulatory changes, domestic and international; serve as a subject matter expert and provide guidance on and interpretation of Good Clinical Practice (GCP) regulations, standards, and quality systems related to clinical investigations
• Actively participate in established committees (i.e AdvaMed working groups) to provide feedback regarding pending regulatory changes affecting clinical investigations through collaboration with multidisciplinary teams
• Provide timely updates to the corresponding procedure/WI/GD, to facilitate compliance with regulatory changes
• Perform gap analysis on newly issued or updated applicable regulatory documentation to support internal assessment of impact
• Perform regular review, at least annually, of departmental GD/WI/SOPs to identify opportunities for improvement and updates needed to ensure continued alignment and compliance with global SOP and WI, as appropriate
• Support internal QA audits as scheduled, serve as primary point of contact through completion of all audit activities pertaining to clinical investigations
• Manage open Teleflex QMS Corrective and Preventative Actions (CAPA) issued to Global Clinical Operations through closure
• Coordinate readiness and participate in regulatory inspections, as needed
• Establish departmental audit schedule and perform periodic review of study records; manage audit through resolution of all necessary audit activities
• Perform periodic review of study records with feedback to promote compliance and audit readiness
• Guide development and execution of study specific Risk Management Plans (RMP) through to closure of the RMP 
• Initiate Teleflex Quality Management System training for new Global Clinical Operations team members 
• Periodically assess QMS training requirements associated with GCO roles, determine appropriate revisions for GCO leadership approval
• Identify and manage GCP and GCO role-specific training requirements for personnel involved in the execution of clinical investigations  
• Adhere to and ensure the compliance with Teleflex Code of Ethics, all Company policies, rules, procedures and housekeeping standards
• Support the Clinical Operations team in general and with various improvement projects
• Perform other duties as assigned
   

Education / Experience Requirements

• Minimum of 7 years of quality systems experience (including but not limited to development of SOP, guidance documents, work instructions; audits); or significant education in quality systems and at least 6 years experience. 
• Minimum of 7 years of clinical research experience with prior IDE study experience; or a bachelor’s degree with at least 6 years of clinical research experience and prior IDE study experience.
• Minimum of 4 years CAPA management from initiation through closure, required. 
• Prior experience with external audits of clinical investigations by regulatory governing bodies; and internal audits performed for quality assurance.
• Minimum of 3 years managing projects, from development through execution and closure. 
   

Specialized Skills / Other Requirements

• Knowledge of FDA and European Union regulatory requirements
• Strong organization, communication, and analytical skills
• Ability to exercise critical thinking, independent decisions and be accountable for actions.
• Ability to develop and implement creative solutions departmental-wide, as needed
• Excellent time management skills
• Proficient in Microsoft Office Suite, Microsoft Outlook, working knowledge in Agile and eTMF systems a plus
• Maximum of 30% travel. May require overnight stays and international travel.
   

TRAVEL REQUIRED: Max of 30%