Clinical Customer Advocate

[rnformatics]

Clinical Customer Advocate

JOB SUMMARY

• Provides clinical support to product development teams, product improvement teams, marketing, sales, quality assurance, regulatory affairs, external customers, and other functions or groups in the form of clinical consultation.
• Responsible for the completion of all tasks associated with management of complaint handling including receiving, investigating, resolving, replying and trend reporting.
• Assesses the severity of complaints and determines how to communicate them for regulatory compliance and optimal root cause resolution.
• Decision-making on filing MDRs with FDA.
• Responding and communicating complaint-related information with FDA and other international agencies.
• Coordinates, recalls, and safety alerts.
• Coordinates the distribution of recall notifications and safety alerts, and summarizes the results of the effectiveness checks.
  
  DUTIES & RESPONSIBILITIES
• This job description does not promise or imply that the functions & responsibilities listed are the only duties or responsibilities to be performed or that the position may not change or be eliminated. Employees are always expected to follow their supervisors’ instructions and to perform the tasks requested by their supervisors.
• Interfaces directly with customers in senior level, as well as staff positions to appropriately assess and effectively communicate the customer’s experience to the Cardinal Health Pyxis Products organization. These customer interfaces can be either via phone / conference calls that are lead by the Customer Advocate, or in person at a customer site visit. Traveling to customer sites with or without the appropriate team members is an integral part the of the Customer Advocate role in demonstrating the our commitment to the customer experience and quality of our products.
• Assumes the lead role in identified customer interactions and planning that involve other Pyxis Products team members, that include, but are not limited to the Technical Support team, Marketing, Project Engineering, Sales and Customer Service Operations.
• Regularly utilizes known strategic thinking and problem solving skills during team meetings, interdepartmental brain storming sessions, Core team meetings and customer interactions.
• Demonstrates consistent and sound negotiation and influencing skills during customer interactions and all team interactions to drive toward identification of root cause and the customer’s experience.
• Provides clinical expert consultation to engineers, marketing, and other individuals/teams. Develops market/product requirements. Provides feedback on product design and assists in business decision-making.
• Identifies needs, plans, coordinates, conducts, and reports on clinical studies to demonstrate product safety and effectiveness, usability and clinical acceptability, and performance in comparison to comparative products.
• Reviews medical/scientific literature to maintain expertise and current awareness of relevant issues to products.
• Develops clinical documentation in forms suitable for external distribution.
• Receives, documents, and processes all complaints received by telephone, fax, mail, customers, affiliates, sales force, customer service and productions.
• Opens files and trends, completes MDR decision trees, enters into complaint database, and updates information daily.
• Completes mandatory Medwatch/Vigilance Reports and insures they are filed in the required time frame to FDA and the international affiliates.
• Faxes all open and closed files to manufacturing site.
• Coordinates the complaint evaluation investigation and follows up on assigned complaints. Gathers additional information needed to determine root cause.
• Reviews investigation findings and assures that the appropriate corrective action has been taken.
• Responds timely to customers in writing, by phone, or faxes to close out files.
• Checks all complaints and related documentation to assure it is complete, easy to understand, and contains rationale for questionable actions taken by ALARIS. Supplies trend search reports to management and engineering on request. Sends list of open complaints weekly to manufacturing sites.
• Facilitates complaints, meets with production and engineering to discuss complaint investigations and corrective action programs.
• Schedules and trains employees on complaint reporting (internal, international, 3rd party technical support and sales force).
• Serves as educator for in-house personnel on complaint and MDR regulations as well as sales personnel and their responsibilities for complaint identification and reporting. Trains new employees in the department on the tasks related to managing complaint files.
• Acts as the primary resource for the FDA or other regulatory agency representative when they have questions related to complaints. Ensures that all complaints are handled in a manner that will meet the latest expectations of the regulatory agency.
• Coordinates the management of complaint evaluation, investigation and follow-up. Reviews findings when appropriate and assures that appropriate corrective action has been taken.
• Audits complaint-related documentation to assure that it is complete, easy to understand and contains rationale for actions taken by ALARIS. Ensures documentation of ongoing efforts of the complaint investigation to show ALARIS' attempts for complete complaint resolution.
• Coordinates all internal activities related to recalls and safety alerts, such as giving direction to temporary workers and summarizing the recall effectiveness check.
• Creates and issues complaint charts and other reports for management's review and action. Understands and manipulates computer database and graphics programs.
• Participates in meetings with engineering to discuss complaint investigation findings and corrective action programs.
• Professional judgment is continually required to ensure that recommendations and interpretations of regulations are of high standards and in line with the business goals of the corporation.
• Ensures documentation of procedures and processes is developed, updated and maintained for the complaint area.
• Performs other duties as assigned.
  
  MINIMUM QUALIFICATIONS
• Bachelors degree (B.S) from a 4-year college or university in nursing, clinical or biomedical engineering, pharmacy, or human factors engineering; minimum of 8 to 12 years experience, to include 3 years experience in, or directly relating to, clinical settings, particularly in the areas of clinical research and medical product evaluation; or equivalent combination of education and experience.
• Product knowledge to assist in troubleshooting complaints (minimum 2 years). Knowledge of regulations for decisions in filing MDRs (minimum 2 years). Skill in oral and written communication and decision-making, including investigations, corrective actions, and MDRs. Knowledge of the ISO 9000 series of standards and the analytical ability sufficient to evaluate potential causes or results of reported product problems and determine appropriate course of action.
  
  These are only minimum qualifications for this position at this grade level. Other factors are taken into consideration when deciding what position and grade level to place an employee such as performance level, capable contribution level and company need.