Project Specialist
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Project Specialist
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Global drug and device development services
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
We are seeking candidates interested in a global study management role, where they will support global project managers across EMEA, APAC, and the US.
In this position, you will work remotely as an integral member of the sponsor’s global study team.
Responsibilities & Tasks:
In this role you will be a key member of the sponsor's Global Study Management Team
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 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
You will be acting as a primary point of contact for vendors, overseeing study-specific deliverables, ensuring continued monitoring and timely delivery of activities delegated to third parties.
Oversight of eTMF completeness
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:
University degree
1 -2 years of clinical trial experience within clinical research
Availability to start within 1 - 2 months max
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.
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Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Are you a current ICON Employee? Please click here to apply
This company provides consulting, development, and commercialization support for drugs and medical devices through a global network of offices. Its team across 53 countries offers end-to-end services, from strategy and regulatory work to manufacturing and market access, helping clients shorten development time, lower costs, and raise quality. It differentiates itself with wide geographic reach and a clear focus on reducing time to market and cost while leveraging deep experience across many therapeutic areas. Its goal is to help clients accelerate the development of life-saving products and improve quality of life by delivering reliable information, practical solutions, and solid performance.
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