Senior Clinical Program Manager AVS
Senior Clinical Program Manager AVS
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Job Description Summary
Job Description SummaryThe GEHC AVS business consists of ultrasound consoles handheld ultrasound devices and ultrasound digital solutions across different market segments. As customers needs for more and consistent digital solutions continue to grow the market for digital ultrasound solutions advances.
We are seeking a highly motivated and experienced individual to oversee all sponsored research for AVS. The ideal candidate will be responsible for mentoring and coaching the team running studies setting expectations and standard work for sponsored studies and directly running all IDE studies.
Job Description
** No sponsorship for this role and will sit in Wauwatosa office **
Key Responsibilities:
- Provide oversight for all sponsored research projects within AVS.
- Mentor and coach the RPI team ensuring they have the support and guidance needed to successfully run studies.
- Set clear expectations and establish standard work procedures for all sponsored studies.
- Directly manage and run all IDE studies ensuring compliance with regulatory requirements and internal standards.
- Collaborate with Quality Regulatory Product leads and Engineering teams to refine and implement research procedures to address AVS needs starting with implementation of the investigational device evaluation procedure.
- Ensure that research activities abide by all defined crossfunctional standards including Phased Review Discipline QMS SOPs GCP and all compliance and regulatory requirements of the applicable regions.
- Develop key partnerships with 3rd party clinical research teams and enable their research with AVS devices.
- Lead monthly reviews of sponsored trials with Clinical Operations.
- Monitor and report on the progress of sponsored studies identifying and addressing any issues that arise.
Qualifications:
- Bachelors Degree in life science engineering clinical field or equivalent.
- 8 years of progressive responsibility and experience in project managing clinical research and development studies in a clinical setting industry or government agency.
- Proven track record in managing complex sponsored clinical trials must have device experience
- Demonstrated understanding/experience with Good Clinical Practices global and regional research regulations including FDA and MDR and ISO standards New Product Introduction (NPI) cycle and clinical trial design.
- Demonstrated ability to build lasting crossfunctional relationships.
Desired Characteristics:
- Masters Degree in science or related field or advanced medical degree.
- Professional certification in Project Management (PMP) or clinical research (CCRP CCRA or CCRN).
Additional Information
GE HealthCare offers a great work environment professional development challenging careers and competitive compensation. GE HealthCare is anEqual Opportunity Employer. Employment decisions are made without regard to race color religion national or ethnic origin sex sexual orientation gender identity or expression age disability protected veteran status or other characteristics protected by law.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID19 some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: No
Required Experience:
Manager
Employment Type
Full-Time
