Key Facts

Remote From:

Full time

Mid-level (2-5 years)

English

Hard Skills

General Surgery Clinical Trials Budget Management Project Management Regulatory Compliance Project Management Vendor Management DOT (Department Of Transportation) Inspections Clinical Trials Pharmaceutical Product Management +8 more

Other Skills

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Team Management
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Analytical Skills
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Leadership
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Time Management
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Teamwork
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Detail Oriented
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Verbal Communication Skills
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Relationship Building
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Problem Solving

Roles & Responsibilities

At least 3+ years of relevant work experience in a pharmaceutical or scientific environment.
Knowledge of clinical trials and the drug development process, including ICH-GCP.
Experience with Trial Master File standards and end-to-end study delivery.
Strong project management, leadership, and external vendor management skills, plus excellent verbal and written English.

Requirements:

Oversee end-to-end operational study delivery from setup to archival, in collaboration with Global Project Managers and Global Trial Managers.
Monitor study conduct, identify, resolve and escalate risks and issues, and ensure timely delivery of deliverables from third parties and internal teams while managing the budget.
Coordinate study activities and communications, maintain interactions with internal and external partners (including CROs and vendors), and ensure data integrity and eTMF readiness.
Oversee budget tracking, change orders, expenses, and ensure consistency between systems and contractual agreements, escalating issues to the Global PM as needed.

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

Study Manager - Remote

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 Manager at ICON, you will work cross -functionally within internal and external partners (e.g. vendors) to deliver delegated operational tasks from Initiation until study archiving to time, quality, budget, company standards.

What You Will Do:

In this role you will work in close partnership with the Global PM and Global Trial Managers on end-to-end operational study delivery activities, from study setup to study archival.

Key responsibilities include:

Monitoring study conduct and progress, identifying, resolving and escalating risks/issues.
Support Global PMs in CRO oversight, overseeing study-specific deliverables, ensuring continued monitoring and timely delivery of activities delegated to third parties
Oversight of Project Specialists activities and ensuring completeness of internal systems/databases/tracing tools and project plans.
Facilitating and maintaining interactions and meetings with internal and external partners (including CROs and third-party vendors) to ensure the successful delivery of assigned studies
Vendor management
Coordinating study-related activities and overseeing study team's communication
Overseeing delivery of clinical supplies, investigational products and all study materials
Data oversight to ensure the study is inspection ready at all times, including oversight of eTMF completeness
Overseeing of budget tracking – managing Task/Change Orders, expenses, tracking updates, checking consistency between systems and agreements and escalating issues to the Global PM.

Your Profile:

At least 3+ years of relevant work experience in a pharmaceutical/scientific environment.
Knowledge of clinical trials, drug development process.
Strong knowledge of ICH-GCP, clinical study delivery process, including regulations, operational best practices, industry standards.
Experience in using Trial Master File industry accepted standard.
Project management skills (preferably with analytical/financial skills) and good leadership skills.
Excellent verbal and written communication in English.
Proven experience in clinical operations and/or study management is required
Strong communication and relationship building skills, including external service provider management skill

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#LI-Remote

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