Study Manager

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: Canada

Work Mode: Remote

• 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.

• Bachelor's, Master's, PhD, MD, or equivalent degree in Life Sciences or a related field.
• Experience with in 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.

• 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.

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.

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

This position is a Job creation
, created to support ongoing project needs.

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.