Key Facts

Remote From:

Full time

Senior (5-10 years)

English

Hard Skills

IEC 61508 Standard Regulatory Compliance Site Assessment Digital File Management Web Analytics Clinical Trial Planning Biomedical Instrumentation Management Reporting International Laws Organizational Structure Stakeholder Communications

Other Skills

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Communication
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Time Management
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Teamwork
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Detail Oriented
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Problem Reporting
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Problem Solving

Roles & Responsibilities

Experience managing clinical trial site start-up and regulatory documentation.
Strong knowledge of ICH-GCP guidelines and applicable local and international regulations (e.g., IEC/IRB processes).
Proficiency with CTMS and eTMF systems and ability to update data and ensure timely documentation.
Excellent collaboration and communication skills with CROs/CRAs, Local Study Team, and cross-functional stakeholders.

Requirements:

Manage country-level study start-up and regulatory maintenance, including collection, preparation, review, and tracking of documents for the application process.
Submit application documents to Regulatory Authorities and/or IEC/IRB during the start-up period.
Update CTMS and other systems with site data, follow up on outstanding actions, and ensure timely collection/uploading of essential documents into the eTMF in line with ICH-GCP and SOPs.
Collaborate with the Local Study Team and CRAs to ensure study start-up milestones are achieved and provide regular updates on milestones and issues to Line Managers.

ICON plc

Pharmaceuticals

About ICON plc

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.

Company type: XLarge

Industry: Pharmaceuticals

Founded: 2018

Company size: 10001

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Job description

Start-Up Manager

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

The Study Start-up/Site Activation Lead is responsible at country level for managing and conducting start-up activities in compliance with the client procedures, documents, local and international guidelines such as ICH – GCP and relevant regulations.

The Study Start-up/Site Activation Lead will prepare, review, track and manage site regulatory documentation at country and site level, and will maintain, review and report on site performance metrics.

The Study Start-up/Site Activation Lead works in close collaboration with the CRAs and the Local Study Team/Local Study Associate Director to ensure that study start-up activities and milestones are achieved in a timely and efficient manner

Typical Accountabilities:

Contribute to ensure that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
Accountable for study start-up and regulatory maintenance being in charge with collection, preparation, review and tracking of documents for the application process;
Accountable for submission of proper application/documents to Regulatory Authorities and/or IEC/IRB during start-up period.
Actively participates in Local Study Team (LST) meetings.

Update CTMS and other systems with data from study sites as per required timelines during the start-up period.
Follow up on outstanding actions with study sites during start-up period to ensure resolution in a timely manner.
Ensure timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, client SOPs and local requirements. Support QC checks performed by Trial Manager or delegate to ensure that all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with client SOPs.
Provide regular information to Line Managers at country level on study and planned study milestones/key issues during the start-up period.

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 or submit a request here.

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 to apply