BD
Manager Clinical Specialist Team
BD, San Diego, California, United States, 92189
Job Description Summary
The Manager, Clinical Specialist Team is responsible for overseeing the team of Clinical Specialists who are tasked to gather facts on customer issues related to adverse events and managing customer relationships by providing a high-level of customer service. The individual must have a customer centric focus while interacting with customers, as well as other team members in professional services and quality. Effective interpersonal skills and professional customer communication skills (verbal & written) are required for outbound customer calls to obtain adverse event details in a timely and expeditious manner.
Job Responsibilities:
(Primary Duties, Roles, and/or Authorities)
Manage, mentor, and orient the team of Clinical Specialists; assist with outbound follow-up phone calls (in lieu of emails) to the healthcare facility on adverse event complaints to gain pertinent information quickly.
Collaborate with professional services and Designated Complaint Handling Unit (DCHU) teams to obtain investigative details on complaints from the healthcare facility.
Work collaboratively with BD investigative lab to pass on any pertinent details quickly from customer calls or correspondence.
Monitor any death or serious injury medical device report (MDR) records through investigation completion to closure ensuring that the adverse event information is comprehensive and meets target timeframes for closure.
Follow up with internal teams (i.e., complaint lab) and HCL associates to process adverse events to closure within a target timeframe.
This position will be a subject matter expert for audits or assessments on adverse events.
This role will organize a team of internal individuals to meet on Additional Information inquiries from health authorities to draft responses for review by internal teams.
Ability to review and summarize medical journal articles received throughout BD on Dispensing Systems to assess if they represent reportable adverse events for medical device reporting.
Incorporate site visit information from on-site teams into complaints, and write and submit reports.
Raise awareness of adverse events to legal, corporate, and management teams.
Prepares weekly death or serious injury MDR adverse event lists for monthly Dispensing post market surveillance reports, ensuring any clinical and legal reviews/comments/corrections are incorporated into the reports.
Expedites any death eMDR submissions for clinical and legal review prior to a timely submission of the report to the FDA.
Periodically review and revise MDR Reportability Guideline to incorporate current failure modes and reportability determinations, expediting the procedural changes through document control.
Work with HCL associates to ensure changes to automated tools are updated based on updated work instructions and MDR Reportability Guidelines.
On occasion, may work with Escalation team to visit or attend a conference with the customer.
Ability to multi-task and work in a fast-paced environment with critical importance on timely MDR submissions.
Overtime may be required on occasion to meet regulatory submission time frames.
Work collaboratively with the Leadership of CPC and TPC teams regarding forwarding customer questions both clinical and technical. Also, to be able to identify and refer customers to these teams for potential education or on-site visits.
Education and Experience:
A Bachelor's Degree in Nursing required and must be a Registered Nurse.
A minimum of 3 years of professional experience directly related to the degree.
Experience in supervision; experience in managing a medical device reporting team is a plus.
Ability to collect, analyze and present clinical data. Must be proficient with computer (Word, PowerPoint, Excel, etc.)
Able to assess problems and overcome objections.
Professional attitude and appropriate business and clinical judgment in all aspects of this position.
Must be able to collaborate with all levels of the organization and with customers at various levels of the health care facility (clinical staff, biomed, C-suite, risk management).
Must have effective interpersonal, telephone, and communication skills (both written and verbal).
Working experience with various software programs, including MS Office (Word, PowerPoint, Excel, and Outlook) required. Experience with TrackWise, SAP, MS Teams, preferred.
Specific knowledge of the Pyxis Dispensing Systems, preferred.
Knowledge and Skills:
Effective oral and written communication skills targeted at all levels within the company.
Strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environment.
Demonstrated ability to manage, develop and mentor exempt and non-exempt level personnel both inside and outside the department reporting structure.
Project management utilizing analytical, technical, and problem-solving skills.
Able to perform multiple complex tasks & prioritize workloads & activities for large volumes of complaints.
Strong organizational skills & proven ability to meet deadlines in an environment of competing priorities.
Excellent computer skills (Including but not limited to: Microsoft Office, Minitab, SAP, TrackWise)
Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.
Demonstrated ability to successfully interact with regulatory authorities during inspections & audit related to complex technical documentation; defending failure investigation activities as failure investigation SME during inspections is a plus.
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The Manager, Clinical Specialist Team is responsible for overseeing the team of Clinical Specialists who are tasked to gather facts on customer issues related to adverse events and managing customer relationships by providing a high-level of customer service. The individual must have a customer centric focus while interacting with customers, as well as other team members in professional services and quality. Effective interpersonal skills and professional customer communication skills (verbal & written) are required for outbound customer calls to obtain adverse event details in a timely and expeditious manner.
Job Responsibilities:
(Primary Duties, Roles, and/or Authorities)
Manage, mentor, and orient the team of Clinical Specialists; assist with outbound follow-up phone calls (in lieu of emails) to the healthcare facility on adverse event complaints to gain pertinent information quickly.
Collaborate with professional services and Designated Complaint Handling Unit (DCHU) teams to obtain investigative details on complaints from the healthcare facility.
Work collaboratively with BD investigative lab to pass on any pertinent details quickly from customer calls or correspondence.
Monitor any death or serious injury medical device report (MDR) records through investigation completion to closure ensuring that the adverse event information is comprehensive and meets target timeframes for closure.
Follow up with internal teams (i.e., complaint lab) and HCL associates to process adverse events to closure within a target timeframe.
This position will be a subject matter expert for audits or assessments on adverse events.
This role will organize a team of internal individuals to meet on Additional Information inquiries from health authorities to draft responses for review by internal teams.
Ability to review and summarize medical journal articles received throughout BD on Dispensing Systems to assess if they represent reportable adverse events for medical device reporting.
Incorporate site visit information from on-site teams into complaints, and write and submit reports.
Raise awareness of adverse events to legal, corporate, and management teams.
Prepares weekly death or serious injury MDR adverse event lists for monthly Dispensing post market surveillance reports, ensuring any clinical and legal reviews/comments/corrections are incorporated into the reports.
Expedites any death eMDR submissions for clinical and legal review prior to a timely submission of the report to the FDA.
Periodically review and revise MDR Reportability Guideline to incorporate current failure modes and reportability determinations, expediting the procedural changes through document control.
Work with HCL associates to ensure changes to automated tools are updated based on updated work instructions and MDR Reportability Guidelines.
On occasion, may work with Escalation team to visit or attend a conference with the customer.
Ability to multi-task and work in a fast-paced environment with critical importance on timely MDR submissions.
Overtime may be required on occasion to meet regulatory submission time frames.
Work collaboratively with the Leadership of CPC and TPC teams regarding forwarding customer questions both clinical and technical. Also, to be able to identify and refer customers to these teams for potential education or on-site visits.
Education and Experience:
A Bachelor's Degree in Nursing required and must be a Registered Nurse.
A minimum of 3 years of professional experience directly related to the degree.
Experience in supervision; experience in managing a medical device reporting team is a plus.
Ability to collect, analyze and present clinical data. Must be proficient with computer (Word, PowerPoint, Excel, etc.)
Able to assess problems and overcome objections.
Professional attitude and appropriate business and clinical judgment in all aspects of this position.
Must be able to collaborate with all levels of the organization and with customers at various levels of the health care facility (clinical staff, biomed, C-suite, risk management).
Must have effective interpersonal, telephone, and communication skills (both written and verbal).
Working experience with various software programs, including MS Office (Word, PowerPoint, Excel, and Outlook) required. Experience with TrackWise, SAP, MS Teams, preferred.
Specific knowledge of the Pyxis Dispensing Systems, preferred.
Knowledge and Skills:
Effective oral and written communication skills targeted at all levels within the company.
Strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environment.
Demonstrated ability to manage, develop and mentor exempt and non-exempt level personnel both inside and outside the department reporting structure.
Project management utilizing analytical, technical, and problem-solving skills.
Able to perform multiple complex tasks & prioritize workloads & activities for large volumes of complaints.
Strong organizational skills & proven ability to meet deadlines in an environment of competing priorities.
Excellent computer skills (Including but not limited to: Microsoft Office, Minitab, SAP, TrackWise)
Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.
Demonstrated ability to successfully interact with regulatory authorities during inspections & audit related to complex technical documentation; defending failure investigation activities as failure investigation SME during inspections is a plus.
#J-18808-Ljbffr