Site Management Associate

ICON; Warszawa; Remote; PLN 90,000 - 150,000; Full time

Benefits offered by this job

Health insurance offerings

Competitive retirement planning

Global Employee Assistance Programme

Flexible optional benefits

EAP program

Childcare vouchers

Job summary

A leading healthcare organization is seeking a Remote Project Specialist to join their global study team in Poland. You'll oversee clinical studies and manage project budgets while tracking compliance and recruitment progress. Ideal candidates will have a Life Science degree and at least one year of experience in clinical trials. Strong skills in Microsoft Office and experience with eTMF are preferred. The role offers competitive salary packages and extensive benefits, including health insurance and retirement plans.

Qualifications

• 1+ years of clinical trial experience within clinical research.
• Experience in global project management would be an advantage.
• Very good comprehension of Microsoft Office tools.
• Proficient in Microsoft Office and Excel for tracking timelines and budgets.

Responsibilities

• Key member of Global Study Team for clinical studies.
• Manage budget oversight and task orders.
• Track recruitment progress and ensure compliance.
• Vendor and CRO oversight with timely deliverables.
• Data oversight including eTMF completeness and quality checks.
• Coordinate meetings with internal and external partners.
• Develop study plans (Monitoring, Vendor, Protocol Deviation, Risk, Communications).
• Monitor study progress and escalate risks.
• Set up systems to ensure data quality and grant system access.

Skills

Life Science degree

Clinical trial experience

Fluent English

Excellent stakeholder management skills

Knowledge of advanced Excel

Budget tracking

Education

Life Science degree

Tools

Microsoft Office 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

Benefits of Working in ICON

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.

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.

Our benefits 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 site to read more about the benefits ICON offers.

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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