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Added 6 mins ago
UO
Early Childhood Educator
University of Victoria
Victoria, BC
- Full-time
…program under the supervision of the ECE Supervisor or Program Manager and follows UVic Child Care pedagogy, ethos and policies; the BC Early Learning Framework; the ECEBC Code of Ethics;…
Added 6 mins ago
SH
Health Care Aide
Shared Health-Soins Communs
Winnipeg, MB
- Full-time
Grow your career in the Winnipeg Health Region! Our team provides a spectrum of health care services through an integrated network of sites, services and organizations. We’re united by a…
Added 6 mins ago
SH
General Duty Nurse (N2) - Child Health - NICU LNG CALL RLF
Shared Health-Soins Communs
Winnipeg, MB
- Full-time
Under the general supervision of the Manager, Health Services, the Registered Nurse (RN) is responsible for providing professional registered nursing services for patients, including those…
Added 6 mins ago
SH
Registered Psychiatric Nurse/Registered Nurse (N2) - MH PX2 West
Shared Health-Soins Communs
Winnipeg, MB
- Full-time
Under the general supervision of the Manager Health Services, the RPN/RN is responsible for providing professional nursing services for patients, including those with complex and…
Added 6 mins ago
SH
Imaging Clerk
Shared Health-Soins Communs
Winnipeg, MB
- Full-time
Under the general direction of the Manager of Diagnostic Services (or designate), the incumbent: Provides reception and clerical support for the department. Provides Administrative support…
Added 6 mins ago
SH
General Duty Nurse (N2) - Child Health - NICU LNG CALL RLF
Shared Health-Soins Communs
Winnipeg, MB
- Full-time
Under the general supervision of the Manager, Health Services, the Registered Nurse (RN) is responsible for providing professional registered nursing services for patients, including those…
Added 6 mins ago
TC
Wealth Manager
The Co-operators - Alfonsi-Torosantucci Insurance Ltd
Hamilton, ON
- Internship
…office provides clients with a range of insurance and financial services tailored to individual and business needs. Team members work closely with the local community, helping clients…
Added 6 mins ago
SH
Primary Nurse Therapist 2 (N4)
Shared Health-Soins Communs
Winnipeg, MB
- Full-time
Under the general direction of the Manager, Health Services, the incumbent applies advanced nursing theory in the assessment, planning, implementation and evaluation of outpatients.
Added 36 mins ago
UO
Systems Administrator Operations
University of Victoria
Victoria, BC
- Full-time
Reporting to the Manager, Data Centre Services, the Systems Administrator Operations works as part of a team to ensure the operational effectiveness of the university’s servers, storage and…
Added 36 mins ago
UO
Client Services Assistant
University of Victoria
Victoria, BC
- Full-time
…parking, motor pool and emergency planning and reporting to the Manager, Commuter Services, the Client Services Assistant (CSA) is responsible for the delivery of front office services…
Added 36 mins ago
SH
General Duty Nurse (N2) - Medicine - Respiratory/General Neurology
Shared Health-Soins Communs
Winnipeg, MB
- Full-time
Under the general supervision of the Manager, Health Services, the Registered Nurse (RN) is responsible for providing professional registered nursing services for patients, including those…
Added 36 mins ago
SH
General Duty Nurse (N2) - Antepartum Gynecology
Shared Health-Soins Communs
Winnipeg, MB
- Full-time
Under the general supervision of the Manager, Health Services, the Registered Nurse (RN) is responsible for providing professional registered nursing services for patients, including those…
Added 36 mins ago
SH
General Duty Nurse (N2) - Gastroenterology Clinic
Shared Health-Soins Communs
Winnipeg, MB
- Full-time
Under the general supervision of the Manager, Health Services, the Registered Nurse (RN) is responsible for providing professional registered nursing services for patients, including those…
Added 36 mins ago
SH
Health Care Aide
Shared Health-Soins Communs
Winnipeg, MB
- Full-time
Grow your career in the Winnipeg Health Region! Our team provides a spectrum of health care services through an integrated network of sites, services and organizations. We’re united by a…
Added 36 mins ago
SH
General Duty Nurse (N2) - Women's Float Team
Shared Health-Soins Communs
Winnipeg, MB
- Full-time
Under the general supervision of the Manager, Health Services, the Registered Nurse (RN) is responsible for providing professional registered nursing services for patients, including those…
Added 36 mins ago
SH
Cardiology Technologist Student
Shared Health-Soins Communs
Brandon, MB
- Internship
Under the direction of the Diagnostic Services Manager, the Cardiology Technologist Student works as part of a multidisciplinary team, to provide best practice Diagnostic Imaging Services…
Added 51 mins ago
WR
Health Care Aide - Home Care Program - Access Downtown 640 Main St
Winnipeg Regional Health Authority (WRHA)
Winnipeg, MB · Greater Winnipeg Metropolitan Area
- Full-time
Site: WRHA Community Health Services - Access Downtown 640 Main St
Added 51 mins ago
RM
Clinical Nurse Specialist Navigator
Ross Memorial Hospital
Kawartha Lakes, ON · Lindsay, ON
- Full-time
Ross Memorial Hospital (RMH) is an active, acute-care community hospital located in the heart of the City of Kawartha Lakes. Among our acute and continuing care services, our team cares for…
Added 51 mins ago
SH
Social Worker (BSW)
Shared Health-Soins Communs
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- Full-time
Shared Health leads the planning and coordinates the integration of patient-centered clinical and preventive health services across Manitoba. The organization also delivers some…
Added 51 mins ago
GO
Occupational Therapist
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Whitehorse, YT
- Full-time
The Yukon’s Department of Health and Social Services aims to promote, protect, and enhance the well-being of Yukon people through a continuum of quality, accessible, and appropriate health…
Added 51 mins ago
AH
Supervisor
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Coronation, AB
- Full-time
…high quality meal service to patients, staff, visitors and the community. You will have the unique opportunity to lead the foodservices teams at the Coronation Hospital & Care Centre,…
Added 52 mins ago
SH
Unit Assistant
Shared Health-Soins Communs
Winnipeg, MB
- Full-time
Under the general supervision of the Manager Health Services, and while demonstrating a commitment to the Mission, Values and Management Philosophy of St. Boniface Hospital, the Unit…
Added 52 mins ago
SH
Unit Clerk - Ambulatory Care
Shared Health-Soins Communs
Winnipeg, MB
- Full-time
Reporting to the Manager Health Services, or Nurse In-Charge and working as part of a multidisciplinary team, the incumbent receives patients to clinic/unit and ensures appropriate…
Added 52 mins ago
KL
Centre Director – Tarsakallak School
Kativik llisarniliriniq
Aupaluk
- Full-time
…Director is the senior administrator of the Board in his/her community and is responsible for all aspects of the organization and administration of the community school and its related…
Added 1 hour ago
RM
Manager - Diagnostic Imaging
Ross Memorial Hospital
Kawartha Lakes, ON · Lindsay, ON
- Full-time
Ross Memorial Hospital (RMH) is an active, acute-care community hospital located in the heart of the City of Kawartha Lakes. Among our acute and continuing care services, our team cares for…

AbbVie

Specialist, Country Study Start Up

Montreal, QC, Canada

Full-time

Apply About employer

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Job details

Job type: Full-time
Apply by: Nov 19, 2026
Posting language: English
Posted: Nov 4, 2026

Original job description

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Our Great Place to Work® Certification highlights our dedication to cultivating a high-trust, and inclusive culture for all.

At AbbVie, you won't just have a job, you’ll have the opportunity to unlock a bright future, because we're not just a workplace; we're a world of possibilities.

Difference makers wanted. Apply now!

What’s In It for You?

Innovative work culture
Professional development
Paid time off: vacation, holidays, personal days, and volunteer days
Employee stock purchase
Wellness spending account
Flexible health insurance
Retirement savings programs
Bonus plan

Job Description

The Specialist, Country Study Start Up proactively drives and executes all start-up and maintenance-related activities and deliverables for assigned studies and sites in their assigned country or countries. For studies that only involve one country, the Specialist, Country Study Start Up is responsible and accountable for one time, budget and quality delivery and execution of the start-up and maintenance activities (i.e.: the United States only trials). Acts as a site start-up expert and provides Subject Matter Expert (SME) support.

Key responsibilities

Ensure successful and on time and quality execution of start-up and maintenance activities for assigned sites and studies; site assignment scope inclusive of central and local Institutional Review Board (IRB)/ Ethics Committee (EC) sites.
Establish the country/site activation plans and priorities including risk assessment and mitigation plans with Country Clinical Operations Manager (CCOM) / Clinical Operations Manager (COM), ASUL and Clinical Site Management (CSM) Lead, Contract Manager, Contract Management Specialist (CMS) /Regulatory Affairs.
Proactively identify and communicate issues impacting delivery and providing proposed solutions.
Attend regional/area start up calls and providing input for assigned sites/studies.
Collect essential documents from sites and completing quality check Attributable, Legible, Contemporaneous, Original, and Accurate. (ALCOA).
Compile and submit ethics and other required local submissions including customization of Informed Consent Forms (ICFs), patient facing materials and safety reporting.
Coordinate with Regulatory and CMS on Competent Authorities (CA) submission and approval status to assure alignment with other site activation requirements.
Collaborate with contract manager, Clinical Research Associate (CRA), Area CSM Lead as required to assure timely site activation.
Review site and IRB/EC comments on ICFs and routing for approval by required functional areas.
Facilitate clinical supply shipments.
Complete Investigational Product (IP) release activities and triggering IP shipment.
Issue site green light letter and activating sites in Interactive Voice/Web Response System (IXRS).
Track all start-ups and maintenance-related activities in Vault Study Start-Up (SSU) as appropriate.
Maintain local country and site intelligence database and Expected Document Lists (EDLs) in Vault.
Maintain SSU performance metrics and key performance indicators (KPIs) for assigned sites/studies.
Provide start up updates and metrics to CCOM/COM and Area SSU and CSM Leads
Ensure audit/inspection readiness.
Ensure compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines.
Drive to improve site start-up efficiency, which includes leading process improvement initiatives.
Function as an SME in the SSU community and leads training and mentoring of Country Start Up Specialists, drive change management in the adoption of new technologies and processes.
Act as an area lead for studies that only involve one country (i.e.: the US only trials).

Qualifications

Experience / Education required

Bachelor's degree in Health Care or Science highly preferred.
A minimum of three years of clinical research experience and preferably more than two years of study start up management experience for the designated region.
Must have hands on experience in interpreting regional clinical research regulations and processes.
Experience working with central and local IRB/EC sites, inclusive of reviewing site and IRB/EC comments on ICFs and routing for approval by required functional areas.
Adept and experienced working with Vault SSU in the capacity of essential document processing, IP release, and ICF IRB/EC review.
Experience working with remote/virtual teams.
Strong analytical and critical thinking skills and the ability to evaluate complex issues from multiple perspectives and drive smart decision-making.
Strong interpersonal skills with the ability to build trust and communicate with clarity, flexibility and adaptability to changing requirements.
Demonstration of a successful start-up execution and aptitude for managing multiple priorities in a fast‐paced environment.
Demonstration of driving and leading successful initiatives, special projects and activities that support the business.
Working knowledge of International Conference on Harmonisation (ICH) and Good Clinical Practice (GCP) guidelines and operational understanding of the country's regulatory environment.
You must be available to attend the head office, located in St-Laurent, QC, occasionally for training purposes.
French and English language proficiency (oral and written).

AbbVie strives to provide a French working environment for its employees in Quebec. Although as part of its francization program has taken all reasonable steps to avoid imposing the following requirement, advanced amount of knowledge of English / Fluency in English is an essential requirement for the position of Specialist, Country Study Start Up including, but not limited to, for the following reasons:

English speaking employees outside the province of Quebec.
English speaking clients outside the province of Quebec.
Anglophone region outside the province of Quebec.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Workday Global Grade: 15

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More about this job

Responsibilities

The Specialist proactively drives and executes all start-up and maintenance-related activities for assigned clinical studies and sites. They act as a subject matter expert, ensuring quality, compliance, and timely site activation while managing risk and regulatory submissions.

Requirements

Candidates must have a bachelor's degree in health care or science and at least three years of clinical research experience. Proficiency in English and French is required, along with hands-on experience in study start-up management and regulatory processes.

Skills

Clinical research
Study start up
Regulatory affairs
Institutional review board
Ethics committee
Informed consent forms
Clinical site management
Vault study start-up
Good clinical practice
Risk assessment
Project management
Analytical skills
Critical thinking
Interpersonal skills
Change management
Mentoring

Benefits

Innovative work culture
Professional development
Paid time off
Employee stock purchase
Wellness spending account
Flexible health insurance
Retirement savings programs
Bonus plan

Visa sponsorship

Not detected in the job text

Keywords

Clinical research
Study start up
AbbVie
Regulatory affairs
IRB
EC
ICF
Vault SSU
GCP
ICH
Clinical operations
Site activation
Risk mitigation
Investigational product
IXRS
KPI
Compliance
Audit readiness
Process improvement
Change management
Mentoring
Clinical site management
Health care
Science
Data management
Project management
Analytical skills
Communication
Collaboration
Regulatory submission

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