Site Management Associate

ICON Clinical Research; Poland; Remote; PLN 180,000 - 260,000; Full time

Benefits offered by this job

Remote work

Global study team

Competitive compensation

Job summary

ICON plc is a world-leading healthcare intelligence and clinical research organization. We are seeking a Project Specialist to support global project managers in EMEA, APAC and US, working remotely as part of the sponsor's global study team.

You will contribute to delivering the clinical study on time, cost and quality, oversee eTMF completeness, budgets, and country oversight, and collaborate with vendors to ensure timely delivery of study activities.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 1+ years of clinical trial experience.
• Experience with eTMF and CTMS is a plus.
• Fluent English with strong communication.
• Proficient in Microsoft Office, especially Excel.

Responsibilities

• Be a key member of the sponsor's Global Study Team contributing to delivering the clinical study on time, cost and quality.
• Oversee budget by managing Task/Change Orders, expenses and updates; escalate issues to the Project Manager.
• Provide country oversight, track recruitment progress, data completeness and regulatory approvals.
• Manage vendors and CROs, ensuring timely delivery of study-related deliverables.
• Oversee data, including eTMF completeness and quality verification of documents.
• Maintain interactions with internal and external partners.
• Develop study plans (Monitoring Plan, Vendor Management Plan, Protocol Deviation Management Plan, etc.).
• Monitor study conduct and progress; identify, resolve and escalate risks/issues.
• Set up and maintain systems/tools to ensure data quality and consistent integration.

Skills

Fluent English

Stakeholder management

MS Office

Communication skills

Data oversight

Education

Life Science degree

Tools

eTMF

CTMS

Job description

Project Specialist - Remote - Poland

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.

We are looking for candidates to work in a role in study management supporting global project managers in EMEA, APAC and US.

In our role you will work remotely and be part of the sponsor's global study team.

Responsibilities & Tasks:

• In this role you will be a key member of the sponsor's Global Study Team contributing to delivering the clinical study to time, cost and quality, and ensuring inspection readiness by taking an oversight over study eTMF completeness
• Responsible for budget oversight - managing Task/Change Orders, expenses, tracking updates, checking consistency between systems and agreements and escalating issues to the Project Manager
• You will be responsible for country oversight, acting as a primary point of contact, tracking of recruitment progress, data completeness and compliance, overseeing local budgets, protocol deviations, risks, regulatory approvals and import license status
• Vendor management and CRO oversight, acting as a primary point of contact, overseeing study-specific deliverables, ensuring continued monitoring and timely delivery of activities delegated to third parties.
• Data oversight, including oversight of eTMF completeness (eTMF setup, periodic reviews, following up on missing documents, Safety Reports Dissemination), and assure that all eTMF documents are complete and verified for quality.
• Maintaining interactions and meetings with internal and external partners
• Responsible for reviewing key clinical documents, including the Protocol and Informed Consent Forms, and leading development of study plans (e.g. Monitoring Plan, Vendor Management Plan, Protocol Deviation Management Plan, Risk Management Plan, Communication Plan etc.) for external and internal use in assigned studies.
• Monitoring study conduct and progress, identifying, resolving and escalating risks/issues
• You will be responsible for setting up and maintaining systems and tracking tools that ensure quality, consistency and integration of study data, following up on discrepancies if needed. Granting access to new system users.

Your Profile:

• Life Science degree
• 1+ years of clinical trial experience within clinical research
• Experience in global project management/supporting global cross-functional teams at study level would be an advantage
• Experience working with eTMF and CTMS
• Fluent English
• Very good comprehension of Microsoft Office tools (Excel, PowerPoint, Word, Outlook, etc.).
• Knowledge of advanced Excel, timelines/budget tracking systems and clinical trial management systems is an asset.
• Excellent stakeholder management and communication skills (oral and written), outstanding interpersonal skills.

#LI-Remote

Benefits of Working in ICON:

Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.

We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.

But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON 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, 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.

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 specialized 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, inclusion & belonging are fundamental to our culture and values. 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.

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

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 maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

Visit our careers site (https://careers.iconplc.com/benefits) to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. 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 or submit a request here (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.

Are you a current ICON Employee? Please click here (https://wd3.myworkday.com/icon/d/task/1422$1235.htmld) to apply