Clinical Quality & Risk Management Analyst
Company: Medpace, Inc.
Posted on: May 13, 2022
Job Summary:We are looking to strengthen the Global Quality
Assurance (QA) team with an experienced QA professional supporting
continuous improvement of Medpace's Quality Management System
through application of Quality Event and Quality Risk Management.
This position will preferably be based in one of the US based
offices (Cincinnati, Dallas, Denver, Minnesota). Other locations or
a home-based position may be considered too, depending on
experience and expertise of the candidate.Responsibilities :The
successful candidate will be responsible for facilitating the
management of Quality Events and identification and evaluation of
Quality Risks through application of Medpace's Quality Event and
Risk Management (QERM) program. Translating data into knowledge and
making best use of knowledge are essential to achieving Medpace's
mission of accelerating the global development of safe and
effective medical therapeutics.
Supporting Medpace's Quality Event Management (QEM) program through
triage, and facilitating QEM steps such as problem definition,
investigation, root cause analysis, CAPA planning and CAPA
effectiveness driving continuous improvement of Quality Management
- Supporting further development systems, and tools to gather,
organize, visualize, trend, and analyze data resulting from Sponsor
Audits, Regulatory Inspections, Medpace Audits (Investigator Site,
Vendor, Internal Process) and QEM Program and relevant external
- Developing and maintaining Quality Metrics to facilitate
identification of potential trends and risks across Medpace
Business Entities and providing actionable insights and
recommendations to Process Owners and training and development
- Leveraging risks at level of process / system to support
proactive improvement of GxP regulated processes and systems and
informing Medpace's audit strategy and schedules.
- Supporting Process Owners with management of operational risks,
including but not limited to risk identification, evaluation,
control and/or monitoring strategies.
- Monitoring the effectiveness of CAPA and risk mitigation plans
through internal process audits.
- Disseminating knowledge to Medpace stakeholders through
training and education.
- Supporting maintenance and development of a risk-based Quality
Management SysQualifications :
- Bachelor's degree required (a more advanced degree preferred)
in science or a related field.
- At least two (2) years of QA experience or at least four (4)
years of operational experience in a GCP regulated environment (a
combination of experience in GxP regulated environment, including
GCP will also be considered). Position level will be determined
based on experience of the candidate.
- Experience in problem solving through investigation, root cause
analysis and CAPA planning.
- Experience in Quality Risk Management is a plus.
- Strong analytical skills.
- Strong quality mindset.
- Excellent written and verbal communications skills in
- Independent thinking and planning ability.
- Experience with a wide range of computerized systems including
MS Office (experience with Business Intelligence tools is a
- Good time management skills.
- Ability to switch between both big picture view and attention
- Ability to develop strong collaborative working relationships
with key stakeholders.
- The ability to work well on a team as well as
independently.Medpace Overview :Medpace is a full-service clinical
contract research organization (CRO). We provide Phase I-IV
clinical development services to the biotechnology, pharmaceutical
and medical device industries. Our mission is to accelerate the
global development of safe and effective medical therapeutics
through its scientific and disciplined approach. We leverage local
regulatory and therapeutic expertise across all major areas
including oncology, cardiology, metabolic disease, endocrinology,
central nervous system, anti-viral and anti-infective.
Headquartered in Cincinnati, Ohio, employing more than 4,000 people
across almost 40 countries.Why Medpace?:When you join Medpace, you
become part of a team dedicated to supporting the development of
ground-breaking drugs and devices. Our employees provide hope for
those living with debilitating diseases. We invite you to be a part
of something that is impacting millions of people around the globe
while enjoying a competitive total compensation and benefits
package and internal growth opportunities.
Organic Growth: Medpace is continuing to grow in all areas globally
and has built an expansive research campus at its headquarters in
Cincinnati, OH. In 2020, Medpace opened a new seven story building
that is approximately 250,000 SQFT. In total, the headquarter's
campus includes five buildings and approximately 600,000 SQFT. The
company also has expanding office locations in Dallas, TX and
Perks (vary by location and position):
- On-site fitness center(s)
- Campus walking paths
- Company-sponsored social and wellness events
- Official Sponsor of FC Cincinnati
- Hybrid work-from-home options and flexible work schedule
- On-site Market Place
- Free and covered parking
- Discounts for local businesses
- On campus restaurants and banks coming soon
- Medpace historically named a Top Cincinnati Workplace by the
- Recognized by Forbes as one of America's Best Mid-size
Companies in 2021
- Medpace ranks amongst top CROs for site ratings across all 10
important attributes including CRA training, preparation &
organization, accessibility of staff, open communication, and
ensuring timely drug availability
- Continually recognized with CRO Leadership Awards from Life
Science Leader magazine based on expertise, quality, capabilities,
reliability, and compatibility
- Ranked in the top 10 on the 2021 LinkedIn Top Companies list in
CincinnatiWhat to Expect Next:A member of our recruitment team will
review your qualifications and, if interested, you will be
contacted for an interview.
EO/AA Employer M/F/Disability/Vets
Keywords: Medpace, Inc., Irving , Clinical Quality & Risk Management Analyst, Healthcare , Irving, Texas
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