Key Facts

Remote From:

Full time

Mid-level (2-5 years)

English

Hard Skills

Medical Device Directive Medical Devices Clinical Trial Management Systems Protocol Analysis Regulatory Compliance Protocol Analysis Budget Management Vendor Management Project Management Compliance Management Stakeholder Communications Clinical Documentation Clinical Trials Design Research Task Management

Other Skills

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Collaboration
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Communication
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Teamwork
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Organizational Skills
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Detail Oriented
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Social Skills

Roles & Responsibilities

Bachelor's degree in a relevant field with a minimum of 3 years of experience in clinical trial management.
Prior experience as a Clinical Research Associate, combined with demonstrated project management experience.
Proven experience managing medical device clinical studies from start-up through close-out.
Strong understanding of medical device regulatory requirements and submission processes.

Requirements:

Lead the end-to-end management of medical device clinical studies across multiple regions from planning through close-out.
Oversee study timelines, deliverables, and budgets, and manage CRO partners to ensure operational excellence.
Ensure regulatory and ethics compliance, including submissions to ethics committees and relevant regulatory bodies.
Oversee study documentation, including Trial Master File quality and preparation of end-of-study reports.

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

Clinical Study Manager (Medical devices) - Kenya

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

We are currently seeking an experienced Clinical Trial Manager to join our diverse and dynamic team. As a Clinical Trial Manager, you will support the delivery of medical device clinical studies across Africa, the Middle East (including Israel), and India. This is a high-impact opportunity to work across diverse and growing regions, contributing to the advancement of innovative healthcare technologies.As Clinical Study Manager, you will take ownership of the operational delivery of medical device clinical studies, ensuring quality, compliance, and timelines are consistently achieved. You will act as a key interface between internal teams, CRO partners, and external stakeholders, driving studies from planning through to execution and close-out.

What you will be doing

Lead the end-to-end management of medical device clinical studies across multiple regions
Oversee study timelines, deliverables, and budgets, ensuring operational excellence
Collaborate with and manage CRO partners to ensure effective study execution
Contribute to protocol development, including defining study endpoints and methodology
Ensure compliance with applicable regulatory requirements, with a strong focus on medical device regulations
Manage submissions to ethics committees and relevant regulatory bodies
Oversee study documentation, including Trial Master File quality and end of study reports
Provide regional oversight across Africa and India, including on-site engagement as required

Your profile

Bachelor's degree in a relevant field, with a minimum of 3 years of experience in clinical trial management.
Prior experience as a Clinical Research Associate, combined with demonstrated project management experience
Proven experience managing medical device clinical studies from start-up through close-out
Strong understanding of medical device regulatory requirements and submission processes
Experience working with CROs and managing external vendors
Hands-on experience writing or contributing to clinical study protocols and endpoints
Track record of submitting to ethics committees and preparing end of study documentation
Experience working across Africa and or India regions is highly desirable
Willingness and ability to travel extensively within the region
Effective communication and interpersonal skills, with the ability to collaborate across diverse teams.
Detail-oriented and organized, with a track record of successfully managing multiple tasks and priorities simultaneously.

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