Study Start Up Manager

ICON Strategic Solutions; Quebec; On-site; CAD 80,000 - 110,000; Full time

Job summary

ICON Strategic Solutions is seeking a Clinical Operations Manager to oversee project management and ensure compliance with international drug development standards. The role involves leading a matrix team, managing timelines, and collaborating with local and global stakeholders. Candidates should have at least 5 years of experience, be bilingual in French and English, and possess strong project management skills. ICON offers a competitive salary and various benefits focused on well-being and work-life balance.

Benefits

Health insurance options for you and your family

Retirement planning offerings

Global Employee Assistance Program

Flexible country-specific benefits

Qualifications

• Minimum 5 years’ experience in clinical operations overseeing project management.
• Fully bilingual in French and English (spoken and written).
• Thorough knowledge of international drug development standards (GCP / ICH).

Responsibilities

• Supports country SSU strategy in collaboration with Study Start-Up Team.
• Accountable for timely start-up activities from country allocation until Green Light.
• Ensures adherence to financial standards and regulatory requirements.

Skills

Project Management

Problem Solving

Negotiation

Interpersonal Skills

Conflict Resolution

Communication

Job description

Exciting study management opportunity with our reputable global CRO aligned with a global exciting sponsor.

What you will be doing :

1. Supports country SSU strategy in close collaboration with Study Start-Up Team Lead, Country Head Portfolio / Cluster Head Portfolio
2. Collaborates with Country / Cluster Head Portfolio, Portfolio Team Leads and global study team to ensure SSU timelines and deliverables are met according to country commitments
3. Accountable for timely start-up activities from country allocation until Green Light (ready to initiate site milestone) in assigned projects
4. Ensures close collaboration with local IRBs / IECs and Health Authorities, as applicable
5. Ensures that study start-up activities are conducted and completed on time, including preparation of IRB / IEC submission packages, review of Informed Consent Forms, engaging Regulatory Affairs / CTA Hub for Health Authorities submissions, as required
6. Prepares and finalizes local submission package for submission to IRB / IEC, CTA Hub (Europe: according to new EU-CTR) as well as Health Authorities as applicable (including subsequent amendments, IBs, DSURs, CSRs)
7. Coordinates timely response to deficiency letters in close collaboration with local and global stakeholders
8. Coordinates reportable events and notifications to IRB / IEC and Health Authorities as applicable
9. Accountable for timelines, accuracy, and quality of country TMF documents in study start-up to ensure TMF inspection readiness
10. Ensures adherence to financial standards, prevailing legislation, ICH / GCP, IRB / IEC, Health Authority, and SOP requirements
11. Implements innovative and efficient processes aligned with client strategy
12. Supports study feasibility in collaboration with Feasibility Manager and Site Partnership Manager as well as the global study team
13. Leads site selection in collaboration with Portfolio Team Lead and Clinical Project Manager if already assigned
14. In satellite countries, oversees local vendor selection and performance as needed. Serves as main contact for quality / compliance issues in SSU phase, escalating as necessary
15. Ensures sites are prepared for “Green Light” and all documentation is in place for initial and subsequent drug release. Responsible for review and sign off of the site “Green Light”
16. Oversees local SSU team activities to achieve start-up timelines and quality execution, proposing and implementing corrective actions where appropriate, according to client standards and regulations
17. Leads / chairs local SSU team meetings, participates in global study team meetings as required
18. Leads the development of country site initiation and patient enrolment plans with SSU CRA, CPM, and others

You are :

1. Minimum 5 years’ experience in clinical operations overseeing project management and/or monitoring clinical trials
2. Capable of leading in a matrix environment, without direct reports
3. Understanding of all aspects of clinical drug development, especially trial setup, execution, and monitoring
4. Strong project management skills with problem-solving and mediation abilities
5. Thorough knowledge of international drug development standards (GCP / ICH), health authorities (FDA / EMA), and local regulations
6. Strong interpersonal, negotiation, and conflict resolution skills
7. Effective communication in a local / global matrixed environment
8. Fully bilingual in French and English (spoken and written)

What ICON can offer you :

Our success depends on the quality of our people. We prioritize building a diverse culture that rewards high performance and nurtures talent.

In addition to a competitive salary, ICON offers various benefits focused on well-being and work-life balance, including:

• Various annual leave entitlements
• Health insurance options for you and your family
• Retirement planning offerings
• Global Employee Assistance Program, TELUS Health, with 24/7 access to support professionals
• Life assurance
• Flexible country-specific benefits such as childcare vouchers, bike schemes, gym discounts, travel passes, health assessments, and more

At ICON, inclusion & belonging are fundamental. We are committed to providing an accessible, discrimination-free workplace. All qualified applicants will receive equal consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.