Study Delivery Specialist

Study Delivery Specialist

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

As a Study Delivery Specialist, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

JOB PURPOSE

• Study Delivery Specialist 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 operational delivery of studies.

JOB RESPONSIBILITIES:

• 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 etc
• Coordination of the study budget –managing expenses, tracking updates, checking consistency between systems and agreements and escalating issues of best practices

Depending on experience/expertise:

• May be involved in reparation and update of study documents and study plans, including, Monitoring Plans, Vendor Providing input to develop study specific processes and procedures, adhering to standardization and dissemination Management Plans, Protocol Deviation Management Plans, Risk Management Plans, Communication Plans etc
• 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 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

QUALIFICATIONS:

• University Scientific Degree or other related field
• At least two years on the similar position (As Global CTA or Global Project Specialist- mandatory)
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
• Ability to manage multiple competing priorities within various clinical trials with good planning, time management and prioritization skills
• Able to think independently, analyse and solve problems systematically and creatively and able to take a risk-based approach

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:

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, colour, 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.

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.

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, 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.

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

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.