Clinical Quality Project Manager
- Poland
- Clinical Monitoring
- ICON Strategic Solutions
TA Business Partner
- Icon Strategic Solutions
About the role
This vacancy has now expired. Please see similar roles below...
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
You will be partnering with a well-known global pharmaceutical company with a strong portfolio inmultiple therapeutic areas.
You will have an opportunity to work in a solid partnership and an environment driven by innovation and continuous improvement. This program is for you if you are looking for an environment where people feel they belong and are empowered to reach their full potential, perform at their best and make a valued contribution to saving lives.
- Drives Operational Excellence within RDQRM as Business Process Consultant (BPC) by providing consultancy on process elaborations/updates/improvements in close collaboration with the respective Business Process Owner (BPO)
- Provides leadership and guidance on Quality Document (QD) & Controlled Document (CD) management activities (e.g., support QD authors during writing process, oversee QD/CD lifecycle management within department in close collaboration with R&D SOP Management)
- Participates in the DEC (Development Excellence Council) as back-up DEC representative for RDQRM, and oversees and manages respective DEC tasks within RDQRM (e.g., manage DEC elaboration & review requests)
- Acts as back-up TAR (Training Assignment Responsible) for RDQRM, i.e., oversees and manages Training assignments in close collaboration with the RDQRM leaders
- Collaborates with RDQRM Leaders as well as BPOs for all related DEC and TAR tasks
- Coordinates stakeholders from various parts of the R&D organization
#LI-MC6
- Minimum 8 years QA experience or relevant experience in international pharmaceutical and/or biotech industry, in particular medical quality management, clinical development, or regular compliance
- In depth knowledge of applicable worldwide regulations and ICH guidelines
- Proven GCP (and GVP) expertise, basic knowledge in other GxP areas a plus (i.e., GLP, GRP, GMP)
- Experienced in Controlled Document management (i.e., writing, reviewing, process modelling)
- Broad knowledge/expertise in continuous improvement with background in appropriate tools/procedure, e.g., strong quality orientation and understanding of metrics; Lean Six Sigma training a plus; demonstrated knowledge of Root Cause Analysis techniques.
- Solid working knowledge of principles and concepts of risk-based Quality Assurance
- Broad understanding of the drug development process and its regulatory environment
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Learn more about Our Culture at ICON
Day in the life
Teaser label
Our PeopleContent type
BlogsPublish date
08/29/2023
Summary
To excel as a Clinical Research Associate (CRA) in a Clinical Research Organization (CRO), you need a combination of education, skills, and the right mindset. Brazil-based CRA II Debora shares her
Teaser label
Our PeopleContent type
BlogsPublish date
05/23/2023
Summary
How to progress as a Clinical Research AssociateTo thrive as a Clinical Research Associate (CRA), it is imperative to cultivate a multifaceted skill set and demonstrate unwavering commitment to exce
Teaser label
A Day In The LifeContent type
BlogsPublish date
04/05/2023
Summary
Senior Clinical Research Associate Suzaita Hipolito talks about the satisfaction gained from working in Clinical Research. “What would it look like to wake up every day feeling happy and fulfilled?
by
Suzaita Hipolito
Similar jobs at ICON
Salary
Location
Taipei
Department
Clinical Monitoring
Location
Taipei
Remote Working
Office Based
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
As a Clinical Research Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.Working location: Taipei, Taiwan, spons
Reference
2024-115730
Expiry date
01/01/0001
Author
Sandy TangAuthor
Sandy TangSalary
Location
Netherlands
Department
Clinical Monitoring
Location
Netherlands
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us
Reference
2024-115831
Expiry date
01/01/0001
Author
Iris BrouwerAuthor
Iris BrouwerSalary
Location
Chengdu
Department
Clinical Monitoring
Location
Chengdu
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
As a Clinical Research Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.Clinical Research Associate
Reference
2024-113273
Expiry date
01/01/0001
Author
Allen HaoAuthor
Allen HaoSalary
Location
United States
Department
Clinical Monitoring
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
As a Sr CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-115895
Expiry date
01/01/0001
Author
Monica HawkinsAuthor
Monica HawkinsSalary
Location
United States
Department
Clinical Monitoring
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
As a Sr CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-115896
Expiry date
01/01/0001
Author
Monica HawkinsAuthor
Monica HawkinsSalary
Location
United States
Department
Clinical Monitoring
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
As a Sr CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-115898
Expiry date
01/01/0001
Author
Monica HawkinsAuthor
Monica Hawkins