Senior Regulatory Requirements Change Expert
ABN AMRO Bank - Amsterdam
Your jobIn your role as Regulatory Requirements Expert within Requirements & Process Change you are responsible for: Ensuring timely and high-quality translation of regulations and policies into implementable (DPOT) - Volledige vacature bekijken
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Senior CRA
Clinical Monitoring
ICON Strategic Solutions
Office Based
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Hi, I am
Iris
and I manage this role
TA Business Partner
- Icon Strategic Solutions
Iris.Brouwer@iconplc.com
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About the role
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.As a
senior
Clinical Research Associate
(senior CRA) you will be accountable for performance and compliance for assigned protocols and sites in
the Netherlands
.
This is a sponsor dedicated role (
area Amsterdam
).
As a
senior
Clinical Research Associate
(senior CRA) you will be accountable for performance and compliance for assigned protocols and sites in
the Netherlands
.
This is a sponsor dedicated role (
area Amsterdam
).
In this role you will be a decision maker, solving problems independently or as part of the client and ICON team.
You will be managing competing priorities, supporting the on-site team, ensuring investigators follow the clinical trial protocol, providing training, and most importantly, motivating the team
to ensure high quality results.
Key responsibilities
You will monitor multiple Phase I, II, III & IV clinical trial sites, across different therapeutic areas. Assist other CRAs with co-monitoring activities both remote and on-site.
You will utilise your customer service mindset with your sites focusing on delivering value, building loyalty and trust to create a positive impact and strong relationship with investigators and study coordinators where respect, knowledge and commitment to ICH/GCP guidelines are key to successful trial conduct.
As the CRA you are the main sponsor representative, providing key project updates. You will collaborate with the team, developing commitment to study timelines and objectives through regular visits with site staff in-person and remotely.
You will be first to review "source to CRF/eCRF," ensuring patient safety and data integrity aspect of the study.
As the first point of contact for study sites, escalating any concerns/issues to other departments including Safety, Investigational Medicinal Product, Local Study Managers and management team as appropriate.
Additionally, you will oversee the sites' adherence to GCP/ICH practices, ensuring quality of study conduct
Requirements
:
Bachelor’s Degree (or equivalent) with 4 years+ years of relevant healthcare experience in the pharma or clinical research industry. Minimum 3 years of monitoring and site management experience
Scientific background
Proficiency with medical terminology
Working knowledge of Local Regulations
A demonstrated working knowledge of ICH/GCP Guidelines
Excellent record-keeping skills and attention to detail
Experience conducting Site Selection, Initiation, Routine Monitoring and Close Out Visits both remotely and on-site
Fluent in English and
Dutch
, both written and oral
Strong technical skills with CTMS, eCRF, eTMF
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON:
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
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Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are ourgreatest 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.
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Learn more about Our Culture at ICON
List #1
Day in the life
Teaser label
Our People
Content type
Blogs
Publish 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
Brazil-based CRA II Debora Oh shares her tips on how to become a great CRA and provides insight into life at ICON.
Read more
Progressing as a CRA with ICON
Teaser label
Our People
Content type
Blogs
Publish 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 excell
Teaser label
Senior CRA Yemi Moses recounts her development and shares her career ambitions with ICON plc.
Read more
Teaser label
A Day In The Life
Content type
Blogs
Publish 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?
Teaser label
Senior Clinical Research Associate, Suzaita Hipolito, talks about how working in Clinical Research gives her happiness and fulfilment.
Read more
by
Suzaita Hipolito
by
Suzaita Hipolito
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