Country Study Manager

Job description

We are looking for a Country Study Manager to lead the planning, execution, and delivery of clinical studies across all phases of the study lifecycle. In this role, you will ensure studies are delivered on time, within budget, and in compliance with quality standards, regulatory requirements, and company processes. You will collaborate with cross-functional teams, Contract Research Organizations (CROs), and investigator sites while driving operational excellence and maintaining strong stakeholder relationships.

Location

Location: Canada
Work Mode: Remote

Key Responsibilities

• Lead and oversee assigned clinical studies from study preparation through close-out, ensuring delivery against timelines, quality standards, and budget.
• Develop, maintain, and monitor country and study-level plans, including timelines, resources, risks, budgets, and quality plans.
• Identify study risks, communicate deviations to key stakeholders, and implement mitigation strategies.
• Represent regional or country Clinical Operations within global study teams and provide operational insights from the affiliate perspective.
• Lead and support local study teams, ensuring alignment with study objectives and operational processes.
• Coordinate study execution with CROs, providing oversight, guidance, and performance feedback to ensure successful delivery.
• Oversee study feasibility, site monitoring activities, Risk-Based Monitoring (RBM) plans, and eTMF completeness.
• Ensure compliance with applicable regulations, Good Clinical Practice (GCP), internal procedures, and quality standards.
• Support regulatory inspections, internal audits, and quality reviews while maintaining inspection readiness.
• Build and maintain strong relationships with investigator sites, alliance partners, and key external stakeholders.
• Contribute to therapeutic area initiatives, including site development, investigator engagement, and cross-functional collaboration.
• Coach and support study team members to promote operational excellence and continuous improvement.

Required Profile

Must-Have Qualifications

• Bachelor's, Master's, PhD, MD, or equivalent degree in Life Sciences or a related field.
• Experience within the pharmaceutical, biotechnology, or related clinical research industry.
• Strong understanding of end-to-end clinical trial management and product development.
• In-depth knowledge of clinical trial regulations, Good Clinical Practice (GCP), and applicable regulatory guidelines.
• Proven experience managing investigator sites, CROs, and complex clinical studies.
• Excellent project management and organizational skills.
• Strong stakeholder management, communication, negotiation, and influencing skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Professional proficiency in English (written and spoken).
• Fluency in the local language of the country where the role is based.
• Willingness to travel domestically and internationally as required.

Nice-to-Have Qualifications

• Postgraduate degree or Master's in Life Sciences or a related discipline.
• Experience representing regional or country operations within global clinical study teams.
• Experience supporting regulatory inspections and quality audits.
• Knowledge of Risk-Based Monitoring (RBM) methodologies and electronic Trial Master File (eTMF) management

Expected Compensation Range:
50K- 70K. The final compensation offered will be determined based on the candidate’s level of experience, skills, and qualifications, in compliance with applicable pay transparency requirements.

Canadian Experience Requirement:
No Canadian work experience is required for this position. Candidates are encouraged to apply regardless of previous Canadian experience.

Artificial Intelligence (AI) Disclosure:
No Artificial Intelligence (AI) tools are used in the screening, assessment, or selection of candidates for this position. All stages of the recruitment process are conducted by human recruiters and hiring managers.

Statement Regarding Job Vacancy:
This position is a Job creation, created to support ongoing project needs.

Recruitment Process & Feedback Timeline:
Candidates will receive feedback on their application within a maximum of 45 days from the date of application or from their most recent interview stage.

Why choose us

• An international community bringing together more than 110 different nationalities
• An environment where trust is central: 70% of our leaders started their careers at the entry level
• A strong training system with our internal Academy and more than 250 modules available
• A dynamic work environment that frequently comes together for internal events (afterworks, team buildings, etc.)

Amaris Consulting promotes equal opportunities. We are committed to bringing together people from diverse backgrounds and creating an inclusive work environment. In this regard, we welcome applications from all qualified individuals, regardless of sex, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.

Who are we?

Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.

At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:

Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!

Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!

Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.

As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.
We look forward to meeting you!