Key Facts

Remote From:

Full time

Senior (5-10 years)

English

Hard Skills

IEC 61508 Standard Regulatory Compliance Digital File Management Project Management Digital File Management Web Analytics Clinical Trial Management Systems Biomedical Instrumentation International Laws Electronic Trial Master File Stakeholder Communications

Other Skills

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Ability To Meet Deadlines
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Multitasking
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Time Management
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Teamwork
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Detail Oriented
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Verbal Communication Skills

Roles & Responsibilities

Bachelor's Degree, preferably in life sciences.
Minimum of 5 years of experience in a Clinical Research environment focusing on Start-Up.
Strong project management skills with a deep understanding of regulatory and submission processes.
Excellent written and verbal communication abilities; proven ability to work under tight deadlines and manage multiple priorities.

Requirements:

Lead country-level start-up activities ensuring regulatory compliance (ICH-GCP, local regulations) and manage site regulatory documentation from country/site level, including preparation, review, and tracking.
Collaborate with CRAs and Local Study Team to achieve study start-up milestones; maintain site performance metrics and update CTMS/eTMF as required.
Submit appropriate application/documents to Regulatory Authorities and IEC/IRB during start-up; follow up on outstanding actions and ensure timely collection of essential documents.
Provide regular updates to Line Managers on milestones and key issues; support QC checks to verify documents before site enrollment in line with SOPs.

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

What you will be doing

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 enroll, 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.

Your profile

Bachelor’s Degree, preferably in life sciences.

Minimum of 5 years of experience in a Clinical Research environment, focusing on Start-Up.

Strong project management skills, with a deep understanding of regulatory and submission processes

Excellent written and verbal communication abilities.

Proven ability to work efficiently to tight deadlines and manage multiple priorities.

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