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Added 1 min ago
BT
Standards and Training Specialist
Baker Tilly Canada
Peterborough, ON
- Full-time
Reporting to the Manager of Professional Standards and Training, this role plays a key part in supporting the professional development of our assurance team and upholding our commitment to…
Added 31 mins ago
AH
Medical-Surgical Coordinator
Alberta Health Services
Westlock, AB
- Full-time
The Medical (OBS/ED/Acute/Ambulatory)/Surgical Coordinator provides leadership and expertise in project management, quality improvement, change management, and service redesign to support…
Added 31 mins ago
AH
Senior Project Manager - Medical/Surgical Coordinator
Alberta Health Services
Westlock, AB
- Full-time
The Medical (OBS/ED/Acute/Ambulatory)/Surgical Coordinator provides leadership and expertise in project management, quality improvement, change management, and service redesign to support…
Added 31 mins ago
C
Case Manager, Addictions Specialist
Cota
Toronto, ON
- Part-time
The Case Manager, Addictions Specilaist is linked to Cota’s Assertive Housing First Team (AHFT), with a targeted focus on individuals residing in encampments in East Toronto. The Housing…
Added 3 hours ago
AT
Project Admin (6 month contact)
AFL Telecommunications
Calgary, AB
- Full-time
This role works closely with the NGM Finance Project Manager, Project Coordinators, Project Analyst, Operations, Accounting, Purchasing, and project delivery teams. The position owns…
Added 4 hours ago
CO
Temporary Technical Lead (Housing Accelerator Fund) Up to 18 Months
City of Saint John
Saint John, NB
- Temporary
Under the general supervision of the HAF Project Manager, you will be part of a high-caliber cross functional team leading the E-Permitting Initiative under the City of Saint John Housing…
Added 4 hours ago
AW
Application Development Manager
Agilus Work Solutions
Mississauga, ON
- $140,000 to $155,000 CAD / year
- Full-time
Experience balancing project delivery, operational support, and modernization initiatives
Added 4 hours ago
'
Forward Deployment Engineer Lead - Manufacturing
''
Toronto, ON
- Full-time
- Other
…strengthen standards and practices without managing their day-to-day…
Added 5 hours ago
A
Project Manager
Actalent
Fort McMurray, AB
- $60 to $80 CAD / hour
- Contract
…managing 1015 smaller projects concurrently through all stages of delivery. The Project Manager coordinates schedules, budgets, stakeholders, and contractors while ensuring projects remain…
Added 5 hours ago
DR
Vice President, Operations
DMC Recruitment Group
Steinbach, MB
- Full-time
…sales and design teams, installation services and extensive project support. This breadth has allowed the business to become a trusted partner throughout the entire building and renovation…
Added 5 hours ago
DR
Business Services Specialist
Durham Region (The Regional Municipality of Durham)
Whitby, ON
- Full-time
Reporting to the Manager, the incumbent will;
Added 5 hours ago
Associate, New Verticals - Canada
DoorDash Canada
Vancouver, BC · Toronto, ON
…skills: data analysis & visualization, business intelligence, project management and stakeholder management. The right candidate is extremely detail-oriented, organized and comfortable…
Added 5 hours ago
WI
Senior Project Manager - Mining Consulting (Sudbury)
WSP in Canada
Sudbury, ON · Greater Sudbury, ON
- Full-time
As a Project Manager / Engineering Manager based in Sudbury, Ontario, you will lead the engineering delivery of complex mining and industrial projects while helping build WSP’s local…
Added 6 hours ago
WI
Senior Project Manager - Mining Consulting (Sudbury)
WSP in Canada
Sudbury, ON · Greater Sudbury, ON
- Full-time
As a Project Manager / Engineering Manager based in Sudbury, Ontario, you will lead the engineering delivery of complex mining and industrial projects while helping build WSP’s local…
Added 6 hours ago
A
Robotics Project Manager
Actalent
Vancouver, BC
- $38 to $52 CAD / hour
- Full-time
The Project Manager will be responsible for the planning, scheduling, budgeting, procurement coordination, and execution of multiple complex robotics and electromechanical product…
Added 6 hours ago
M
Account Manager - Programmatic & Paid Social
Monks
Toronto, ON
- Full-time
Leverage programmatic platforms such as DV360, The Trade Desk, Amazon DSP, and Campaign Manager 360 to support campaign delivery and performance.
Added 6 hours ago
Project Manager
RHI Magnesita
Brantford, ON
Provide subject matter expertise in construction management and project delivery best practices.
Added 6 hours ago
Manager, Indigenous Relations
British Columbia Lottery Corporation
BC · Hybrid - Kamloops or Vancouver, BC
Reporting to the Director of Social Purpose, Partnerships and Engagement, the Manager, Indigenous Relations leads BCLC’s Indigenous Relations function and is accountable for the…
Added 6 hours ago
W
Senior Project Manager - Mining Consulting (Sudbury)
WSP
Fredericton, NB
- Full-time
As a Project Manager / Engineering Manager based in Sudbury, Ontario, you will lead the engineering delivery of complex mining and industrial projects while helping build WSP’s local…
Added 6 hours ago
SCM Category Manager, Rotating, Process & E&I Equipment, Pacific Link
Trans Mountain
Calgary, AB
…working closely with engineering, construction, operations, and project stakeholders to ensure successful project execution. This position offers the opportunity to influence major…
Added 7 hours ago
RH
Marketing Project Manager
Robert Half
Surrey, BC
- Contract
We are seeking an experienced Communications / Marketing Project Manager to support a major infrastructure modernization initiative with a leading utilities organization. The successful…
Added 7 hours ago
A
Chef de projet entrée en service / Entry Into Service Project Manager
Airbus
Mirabel, QC · Montreal, QC
- Full-time
The A220 commercial aircraft Programme is looking for an Entry Into Service Project Manager to join our Customer Services team ba
Added 7 hours ago
D
Senior Manager, Strategic Project Management
Datasite
Toronto, ON
- Full-time
The Senior Manager of Strategic Project Management leads Datasite's highest-priority cross-functional initiatives from definition through delivery, including go-to-market readiness,…
Added 7 hours ago
GT
Transfer Pricing Manager (Happy to talk flexible working)
Grant Thornton Cyber Defence Centre
Manchester, NS
- Full-time
As a Manager within our Transfer Pricing team you will:
Added 7 hours ago
H
Directeur Ingenierie Mecanique (support à la production) / Manager – Mechanical engineering (support to Production)
Hitachi
Varennes, QC · (HE)Office_QC, Varennes
- Full-time
…reliable, and resilient energy future. As Mechanical Engineering Manager, you will oversee a team responsible for the design, development, and technical support of transformer products…

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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