As a GLOBAL Study Delivery Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Role’s alignment with equivalent positions in the pharma industry (in both locations) and
internally with ClinOps , in regard to scope and experience
Role’s positioning in the Study Delivery Team structure and against their key stakeholders, also in
relation to the Study Delivery Specialist and Study Delivery Associate
Expectation for the role to have a broader influence on the business, by contributing to continuous
improvement initiatives across processes and systems
We are looking for a Global experienced candidates in HUNGARY, Romania, Bulgaria based.
• Study Delivery Specialist (SDS) is responsible for end-to-end operational study delivery, with
the focus on
completion and maintenance of internal systems/databases/tracking tools and project plans (CSAP)
and supporting the study team in study coordination activities and administrative activities.
• Depending on experience and expertise, SDS may also contribute to development/review of study
documents, vendor management, cooperation with Local Operating Companies (LOCs) and other internal
functions, if required.
• SDS is considered a key role in ensuring inspection readiness state by taking an oversight over
study eTMF completeness.
• SDS executes trial management activities, as delegated by Study Delivery Lead (SDL) for in-house
and outsourced studies across all phases and therapy areas, in accordance with standard operating
procedures, clinical operational plans, regulatory requirements and Good Clinical Practice
• Working in close partnership with SDL and SDM, SDS plays a key role in successful study
delivery, providing subject matter expertise across key processes and systems through the live
cycle of the study.
• SDS role is implemented to have a broader impact on the business, by driving continuous
improvement initiatives within their remit of expertise, sharing best practices across the
business, with a focus on increasing efficiency
• 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.
• Supporting SDL in quality and data oversight to ensure inspection/audit readiness, including
oversight of eTMF completeness (eTMF setup, periodic reviews, following up on missing documents,
Safety Reports Dissemination)
• Support in managing the study team's communication: meetings (preparation, scheduling, meeting
minutes), info- spaces, newsletters, action logs, communication plans, team lists ect
• Coordination of the study budget –managing expenses, tracking updates, checking consistency
between systems and agreements and escalating issues
• Providing input to develop study specific processes and procedures, adhering to standardization
and dissemination of best practices
Depending on experience/expertise:
• May be involved in reparation and update of study documents and study plans, including,
Monitoring Plans, Vendor Management Plans, Protocol Deviation Management Plans, Risk Management
Plans, Communication Plans ect
• May act as Local Operating Companies liaison / oversight – including tracking of recruitment
progress, data completeness and compliance, local budget oversight, protocol deviations oversight,
supplies’ availability, regulatory approvals and import license status
• May be involved Vendor management & CRO oversight – agreeing on study-specific setup
requirements, ensuring continued monitoring of agreed delegated activities
• May contribute to Risk management – contribution to maintenance of a comprehensive risk
management plan and risk tracking
• May be involved in clinical supplies and recruitment materials management – having oversight on
study level supplies availability, recognizing and communicating issues to continuity of supplies,
proposing solutions as appropriate
Graduate or Bachelor level with at least 1+ years of relevant
working experience in GLOBAL role in CRO or pharmaceutical / scientific environment.
Scientific background and knowledge of clinical trials (including ICH-GCP) is an asset.
Foundation experience in clinical trial delivery, including processes, regulations, operational
best practices, industry standards. Well familiar with key systems used in clinical trial delivery.
Experience of using Trial Master File industry accepted standard
Strong project management skills (preferably with analytical/financial skills).
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.
