Principal, Study Start Up Associate
- Poland
- Study Start Up
- ICON Strategic Solutions
- Remote
Principal Talent Acquisition Business Partner
- Icon Strategic Solutions
About the role
As a Principle Study Start Up Associate, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Services Overview:
Principal Start Up Associate (EU Clinical Trial Submission Coordinator) is responsible for coordinating the operational and strategic aspects of clinical trial submissions applicable for countries in scope of the EU CTR for internally managed, and/or outsourced, trials, including compound level coordination. They co-ordinate the EU CTR operational clinical trial submission strategy - and develops, drives and monitors timelines/milestones. They work with central teams and country teams to ensure all information and documentation for submission to the EMA Clinical Trial Information System (CTIS) are completed and performed on a timely and compliant basis.
Responsibilities include planning a compound and trial level EU CTR combined operational submissions strategy with relevant cross-functional involvement throughout the entire trial lifecycle. This role will be responsible for driving the discussions, consolidate input from all stakeholders and facilitate discussions via scenario planning with a view to agree the final EU CTR submission strategy. In addition, this role will be responsible for coordinating submissions in the CTIS portal.
This position interfaces with stakeholders internal and external to Global Operations functions, such as the CTIS Administrator, GCO Country Local Submission Coordinator (local point-of-contact), Clinical Trial Manager (CTM), Global development Trial Leader (GTL), Global Regulatory Clinical Trial Application Submissions Manager (Global CTA SM), CRO point of contact, and other relevant functional area stakeholders as needed. They collaborate closely with the GTL, CTM (if applicable), LPOC and CTA SM, and are a member of the Trial Team.
Major Duties/Responsibilities operations
- Lead the EU Submission strategy development, planning and delivery as a member of the Cross Functional Trial Team (CFTT)
- Clinical trial planning, submissions and notifications
- Financial planning and tracking
- Cross functional submission management
- Ensure compliance with global Health Authority regulations and guidelines and internal operating procedures and processes. Participate in preparation for, and conduct of, Health Authority inspections and internal audits.
- BS degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
- Required: Global clinical research regulation knowledge and understanding, strong project planning/management expertise and effective communication skills.
- Experience and ability in coordinating global teams in a virtual environment for a minimum of 2, preferably 3 years.
- Proven track record in successfully managing multinational clinical trial submissions to Health Authorities and or/ Ethics Committees.
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: https://careers.iconplc.com/benefits
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.
https://careers.iconplc.com/reasonable-accommodations
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-DD1
#LI-remote
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
Similar jobs at ICON
Salary
Location
Mexico, Mexico City
Location
Mexico City
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Feasibility
Patient Recruitment
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
JR128483
Expiry date
01/01/0001
Author
Olivia MolinaAuthor
Olivia MolinaSalary
Location
Mexico City
Department
Study Start Up
Location
Mexico City
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Study Start Up
Job Type
Permanent
Description
We are currently seeking a Clinical Trial Administrator to join our diverse and dynamic team. As a Clinical Trial Administrator at ICON, you will play a pivotal role in assisting with the design and a
Reference
2025-117453
Expiry date
01/01/0001
Author
Rita VillavicencioAuthor
Rita VillavicencioSalary
Location
Mexico, Mexico City
Location
Mexico City
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
Job Type
Permanent
Description
We are currently seeking a Study Start Up Associate to join our diverse and dynamic team. As a Study Start Up Associate I at ICON, you will play a pivotal role in facilitating the initiation of clinic
Reference
JR129092
Expiry date
01/01/0001
Author
Daniela GuerreroAuthor
Daniela GuerreroSalary
Location
Mexico, Mexico City
Location
Mexico City
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Study Start Up
Job Type
Permanent
Description
We are currently seeking a Study Start Up Associate II to join our diverse and dynamic team. As a Study Start Up Associate II at ICON, you will play a pivotal role in leading the initiation of clinica
Reference
JR129088
Expiry date
01/01/0001
Author
Daniela GuerreroAuthor
Daniela GuerreroSalary
Location
Mexico City
Department
Study Start Up
Location
Mexico City
Business Area
ICON Strategic Solutions
Job Categories
Study Start Up
Job Type
Permanent
Description
As a Study Support Assistant you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2025-118217
Expiry date
01/01/0001
Author
Rita VillavicencioAuthor
Rita VillavicencioSalary
Location
Mexico
Department
Study Start Up
Location
Mexico
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Study Start Up
Job Type
Permanent
Description
As a Site Activation Partner/ Study Start Up Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.Providing innovat
Reference
2025-118139
Expiry date
01/01/0001
Author
Magda ObregonAuthor
Magda Obregon