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ICON Strategic Solutions

Sr Start-up Manager

Burlington, ON, Canada

Full-time

Apply About employer

Applications open in a new tab.

Job details

Job type: Full-time
Apply by: Nov 26, 2026
Experience: Minimum of 5 years of experience in a Clinical Research environment, focusing on Start-Up.
Posting language: English
Posted: Oct 27, 2026

Original job description

Start-Up Manager

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized 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

Apply About employer

More about this job

Responsibilities

Manage country-level clinical study start-up and site activation, including preparing, reviewing, tracking, and submitting regulatory and essential documents to authorities and ethics committees. Coordinate with study teams and sites, maintain study systems and performance metrics, follow up on outstanding actions, and ensure start-up milestones and compliance requirements are met.

Requirements

A bachelor’s degree, preferably in life sciences, and at least five years of clinical research experience focused on start-up are required. The role also calls for strong project management and regulatory submission knowledge, excellent communication, and the ability to meet tight deadlines while managing multiple priorities.

Skills

Clinical Study Start-Up
Site Activation
Regulatory Submissions
Regulatory Documentation
Project Management
Clinical Research
ICH-GCP Compliance
Regulatory Compliance
Essential Document Management
eTMF Management
CTMS Data Management
Site Performance Metrics
Clinical Feasibility Assessment
Quality Control
Stakeholder Collaboration
Deadline Management

Benefits

Annual Leave
Health Insurance
Retirement Planning
Employee Assistance Programme
Life Assurance
Childcare Vouchers
Bike Purchase Schemes
Discounted Gym Memberships
Subsidized Travel Passes
Health Assessments

Visa sponsorship

Not detected in the job text

Keywords

Clinical Research
Clinical Trials
Study Start-Up
Site Activation
Regulatory Affairs
Regulatory Submissions
Regulatory Authorities
IEC/IRB
ICH-GCP
Clinical Feasibility
Site Regulatory Documentation
Essential Documents
eTMF
CTMS
Site Performance Metrics
Local Study Team
Clinical Research Associates
Trial Management
Quality Control
Sponsor-Dedicated Model
Pharmaceutical Manufacturing

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