Clinical Trial Manager – Clinical Operations

dicentra Inc.; Canada; À distance; CAD 90 000 - 120 000; Plein temps

Résumé du poste

dicentra Inc. is seeking an experienced Clinical Trial Manager to oversee active programs, site operations, and monitoring activities. The role can be full-time, part-time fixed-term, or independent consulting, depending on experience.

You will own operational delivery for studies across phases, ensure ICH-GCP compliance, and coordinate with data management and vendors to meet milestones while communicating effectively with sponsors and investigators.

Qualifications

• 5+ years of clinical research experience, with 3+ years in management or senior CRA roles.
• Deep knowledge of ICH-GCP guidelines and health authority requirements.
• Proven ability to drive trials to milestones and manage sponsor relationships.

Responsabilités

• Oversee Phase I–IV studies, site management, and monitoring activities.
• Coordinate data management, vendor interactions, and regulatory submissions.
• Serve as primary contact for sponsors, investigators and external partners.

Connaissances

Clinical trial mgmt

ICH-GCP knowledge

Project management

Cross-functional collaboration

Sponsor management

Formation

Bachelor’s or Master’s degree in Life Sciences

Outils

EDC (Electronic Data Capture)

Description du poste

Clinical Trial Manager – Clinical Operations

For over 25 years, dicentra has been a trusted global leader in regulatory consulting and clinical research for the life sciences and dietary supplement industries. We partner with innovators worldwide to navigate complex regulatory landscapes, turn scientific rigor into commercial success, and bring safe, compliant products to market.

We have an immediate opening for an experienced Clinical Trial Manager to oversee active clinical trial programs, trial site operations, and monitoring activities. We are open to full-time or part-time fixed-term employment, as well as independent consulting arrangements, depending on the candidate’s experience and availability.

The Opportunity

In this role, you will take operational ownership of Phase I–IV clinical studies. You will oversee clinical site management, coordinate site monitoring, troubleshoot clinic-level challenges, ensure ICH-GCP compliance, and work cross-functionally with data management and trial vendors to hit study milestones on schedule.

You will also serve as a key point of contact for sponsors, investigators, and external partners, ensuring effective communication and timely resolution of study-related challenges.

Key Responsibilities

• Trial Planning & Execution: Plan, initiate, and manage clinical studies in compliance with ICH-GCP, study protocols, and company SOPs, ensuring study timelines, budgets, and deliverables are met.
• Monitoring & Site Management: Coordinate clinical site monitoring activities, verify data integrity, and support clinical trial sites directly.
• Clinic Problem Resolution: Act as primary escalation contact for trial sites and clinical staff, proactively troubleshooting deviations, patient recruitment hurdles, and operational bottlenecks.
• Vendor & Data Coordination: Collaborate with Data Management and trial vendors on CRF review, EDC user acceptance testing (UAT), query resolution, and database lock.
• Ethics & Regulatory Submissions Support: Support site-level IRB/REB submissions, essential document collection, and inspection-readiness maintenance.
• Clinical Documentation Oversight: Review and provide operational input on study protocols, informed consent forms, and other essential clinical trial documentation.

Qualifications & Background

• Education: Bachelor’s or Master’s degree in Life Sciences, Health Sciences, Nursing, or related field.
• Experience: 5+ years of clinical research experience, with at least 3+ years in clinical trial management or senior CRA/site monitoring roles within a CRO or sponsor environment.
• Regulatory Acumen: Deep working knowledge of ICH-GCP guidelines and Health Canada / FDA clinical trial operational requirements.
• Execution Focus: Strong project management abilities, organizational skills, and a track record of driving trials to database lock.
• Sponsor & Stakeholder Management: Demonstrated ability to independently manage sponsor relationships, coordinate cross-functional teams, and resolve complex clinical trial challenges.

Best Workplace

We nourish an environment devoted to honesty and fairness, trust and respect. We care deeply for our team members and take work-life balance seriously, allowing our people to decide on a schedule that best fits their life and working preferences.

Best People

We unite cross-industry professionals with a shared passion for improving people’s health and wellness. Our inspiring leaders are accessible and work eagerly side-by-side with individual employees to help them understand and achieve their objectives.

Best Opportunities

We encourage our team members to continuously develop and enhance their skills and expertise. We recognize and reward courageous choices and innovative ideas that result in the growth of our people and company, and the success of our clients.

Become a part of a purpose-driven and future-oriented business that impacts and improves millions of lives worldwide!

Job Type: Full-Time Employment, Part-Time Employment, or Independent Consulting Contract (Project-Based / Ad-Hoc)

Location: Ontario (Fully Remote)