Clinical Risk Manager
Talent Acquisition Business Partner
- Full Service Division
About the role
This vacancy has now expired. Please see similar roles below...
We are looking for a Clinical Risk Manager to join our Risk Based Quality Management team as people leader and line manager for RBQM.
Candidates should have strong knowledge of Risk Based Quality Management, Risk Based Monitoring, and Central Monitoring requirements in the Pharma or CRO industry. Line Management experience preferred.
We are looking for someone with excellent people leader, coaching skills and critical thinking skills, to support team governance, development and growth.
Role can be based in US or EU
Main job functions/responsibilities will be as follows:
- Recognize, exemplify and adhere to ICON's values, which center on Accountability & Delivery, Collaboration, Partnership and Integrity.
- Recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
- Executes the responsibilities of disciplined adoption and robust implementation of ICON's Risk Based Quality Management across ICON and with customers, communicating with clarity.
- Deliver and maintain client-focused reporting to measure performance and proactively identify issues.
- Drives and implements change management, process review & design as well as development of effective training.
- Prepare, design and present or support at proposals, bid defences, KOMs, Sponsor Audits.
- Contributes to the development and implementation of the services of the Clinical Efficiency, Quality and Prevention in support of PMOG and Project Management, establishing standards and maintaining systems to measure quality/risk in performance against the established standards.
- Plans and Manages disciplined and robust implementation of Clinical Risk Management, supporting Risk assessments; monitors effectiveness of Risk Identification, Risk Mitigation and Risk Prevention approaches.
- Conducts Quality Control activities to identify Risks.
- Makes independent decisions that have impact on the services and clinical trials regarding the Risk Based Quality Monitoring strategy.
- Provide lessons learned and expertise, as relevant.
- Liaise and co-operate with IT, Clinical Data Services, Quality Assurance in determining strategies and technologies to address Risk and Opportunities for the development of new business.
- Act as an expert advisor on ICH GCP, ICON SOPs/WPs and all stages of study set-up, monitoring and study close-out for assessment of quality compliance processes for monitoring activities
- Establish and maintain necessary communication strategy for the improvement and awareness of quality issues across all departments.
- Act as Enterprise level lead and provide expert RBQM and RBM knowledge for agreed key client partnership accounts.
- Makes sound decisions based on available information in order to contribute to the success of ICON.
- Delivers with high quality standards and strives for excellence; acts in a proactive, flexible and responsive manner to customer needs.
- Establishes good relationships internally and externally.
- Maintains awareness of evolutions in technology, sponsor and competitor positions as well as regulations affecting Risk Based Monitoring.
- Travel (approximately 30%) domestic and/or international.
What you need:
- University/Bachelor's Degree in medicine, science or equivalent degree/experience.
- Thorough knowledge of ICH GCP and relevant regulations for the conduct of clinical trials, with specific focus on updates about Risk Based Quality Management and Central Monitoring.
- 8+ years experience in Clinical Research with 4+ years experience in central monitoring and line management, or relevant skillset.
- Fluent in written and spoken English
- Due to the nature of this position, it may be required for the employee to travel. Therefore, dependent on the employee's location, the employee may be required to possess a valid Driver's license and passport.
Application process
Once you find a job opening that fits your skills and interests, you can create an account, apply and check back on the progress of your application or apply for other roles. Once your application has been received, a confirmation email will be sent to your email.
Remember: this is our first time meeting you. Read the job description and highlight on your CV those experiences that we should learn about.
One of our experienced recruiters will read your profile and determine if you're fit for the role and the company. We are aware of instances where fake recruitment text messages and emails that can appear to come from ICON have been received by individuals. Always delete suspicious text messages or emails. Never give out personal financial information.
Reasonable AccomodationsDay in the life
Teaser label
Our PeopleContent type
BlogsPublish date
03/27/2024
Summary
Exploring Lucy's Path: From Science to Communications Lucy's career journey is a testament to the power of adaptability and seizing opportunities as they arise. "I've been in Clinical Research si
Teaser label
Career ProgressionContent type
BlogsPublish date
03/27/2024
Summary
Interviews can be nerve-wracking experiences, but with the right preparation, you can enter the room with confidence and increase your chances of success. Preparing for an interview is crucial a
Teaser label
Career ProgressionContent type
BlogsPublish date
03/27/2024
Summary
Clinical research plays a crucial role in advancing medical knowledge and improving patient care. At the heart of every successful clinical research study is a Clinical Research Coordinator (CRC
Who we are
Similar jobs
Salary
Location
Mexico, Mexico City
Location
Mexico City
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Trial Support
Job Type
Permanent
Description
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own I
Reference
JR116519
Expiry date
01/01/0001
Author
Kashifa TahseenAuthor
Kashifa TahseenSalary
Location
Netherlands, Groningen GRQM (PRA)
Department
Full Service - Early Clinical and Bioanalytical Solutions
Location
Groningen
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Data Management
Job Type
Temporary Employee
Description
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own I
Reference
JR116495
Expiry date
01/01/0001
Author
Stephanie Broize-ArrieuAuthor
Stephanie Broize-ArrieuSalary
Location
Japan, Tokyo
Department
Full Service - Project Management
Location
Osaka
Tokyo
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Project/ Program Management
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotech
Reference
JR114298
Expiry date
01/01/0001
Author
Daiki MatsumotoAuthor
Daiki MatsumotoSalary
Location
Taiwan, Taipei
Department
Clinical Monitoring
Location
Taipei
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Trial Support
Job Type
Permanent
Description
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own I
Reference
JR118189
Expiry date
01/01/0001
Author
Candice WangAuthor
Candice WangSalary
Location
Korea, Seoul
Department
Study Start Up
Location
Seoul
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
Job Type
Permanent
Description
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own I
Reference
JR117225
Expiry date
01/01/0001
Author
Daisy ParkAuthor
Daisy ParkSalary
Location
United States
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Logistics & Supplies
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
2024-109389
Expiry date
01/01/0001
Author
Brandon PupekAuthor
Brandon Pupek