Clinical Study Manager
- Netherlands
- ICON Strategic Solutions
- Clinical Trial Management
- Remote
TA Business Partner
- Full Service Division
About the role
This vacancy has now expired. Please see similar roles below...
As a Clinical Trial Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Sponsor policies and procedures, quality standards and adverse event reporting requirements internally and externally.
Under the oversight of Senior Clinical Trial Manager the person is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure site readiness.
Responsibilities include, but are not limited to:
- Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).
- Oversees and tracks clinical research-related payments. Payment reconciliation at study close-out. Financial forecasting
- Develops local language materials including local language Informed Consents and translations. Interacts with Ethics Committee and Regulatory Authority for assigned protocols.
- Manages country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.
- Contributes to the development of local SOPs.
- Coordinates and liaises with study team (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.
- Provides support and oversight to local vendors as applicable.
- Oversees and coordinates local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management.
- Ownership of local regulatory and financial compliance.
- Required to in/directly influence investigators, external partners and country operations to adhere to partners and country operations to adhere to budget targets and agreed payment timelines.
- 5 years of experience in clinical research or combined experience in Clinical Research and Finance/Business
- Bachelor's Degree in Business Finance/ Administration/ Life Science or equivalent Health Care related experience
- Experience in Submission Specialist role, with knowledge/experience of contract and budget negotiation
Why you are a good fit for this role:
- You are a strong communicator, have strong leadership, and negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal, in Dutch and English.
- You are problem-solver, independant worker and like the dynamics of start-up!
Why ICON?
- Rewarding career in clinical research: various kind of development opportunities: whether you want to further develop within your role, develop towards a different role or upwards, ICON is able to support you with dedicated line managers, training programs and a variety of clients!
- Competitive salary packages with extra advantages. Company car (with fuel card) or car allowance
- 80 to 100% working time
- Work-Life balance
Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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.
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.
#LI-Hybrid
#LI-VV1
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 Read more
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
Career ProgressionContent type
BlogsPublish date
02/17/2023
Summary
Clinical Trial Managers and Clinical Project Managers are an integral part of the clinical market. Each role is essential in ensuring that clinical trials are well run and completed to a high stan
Teaser label
Inside ICONContent type
BlogsPublish date
10/03/2022
Summary
In traditional clinical trials, patients must attend regular check-ins at hospitals or clinics but fully remote decentralised clinical trials (DCTs) and hybrid trials limit this by replacing the in-pe
Similar jobs at ICON
Salary
Location
Netherlands, Groningen GRQP
Department
Full Service - Early Clinical and Bioanalytical Solutions
Location
Groningen
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
The Clinical Study Manager II provides clinical trial management for in-house and outsourced studies, performs quality checks, protocol and document development, and executes study delivery plans alig
Reference
JR124732
Expiry date
01/01/0001
Author
Hajni HowardAuthor
Hajni HowardSalary
Location
United States, Canada
Department
Clinical Trial Management
Location
Canada
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
As a Manager, Clinical Operations at ICON, you will play a pivotal role in overseeing the execution of clinical trials, ensuring that they are conducted efficiently, on time, and in compliance with re
Reference
2024-114852
Expiry date
01/01/0001
Author
Brendan HoeyAuthor
Brendan HoeySalary
Location
Argentina
Department
Clinical Trial Management
Location
Argentina
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial 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
2024-111424
Expiry date
01/01/0001
Author
Tulio SanquizAuthor
Tulio SanquizSalary
Location
United States
Department
Clinical Trial Management
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
Overview: This individual performing the services is responsible for Supporting the Project Management of RTSM including (but not limited to) development, UAT testing, administration of documentation
Reference
2024-114633
Expiry date
01/01/0001
Author
Jamie PruittAuthor
Jamie PruittSalary
Location
Mexico, Mexico City
Department
Clinical Trial Management
Location
Mexico City
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
We are currently seeking a Clinical Trial Manager to join our diverse and dynamic team. As a Clinical Trial Manager at ICON, you will play a pivotal role in overseeing and optimizing centralized clini
Reference
JR120126
Expiry date
01/01/0001
Author
Michael HartleyAuthor
Michael HartleySalary
Location
Brazil, Sao Paulo
Department
Clinical Trial Management
Location
Buenos Aires
Sao Paulo
Mexico City
Lima
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
We are currently seeking a Senior Clinical Trial Manager to join our diverse and dynamic team at ICON Plc. In this critical role, you will be responsible for overseeing the planning, execution, and su
Reference
JR124159
Expiry date
01/01/0001
Author
Michael HartleyAuthor
Michael Hartley