Clinical Operations Manager, Gestionnaire des opérations cliniques, Canada

Indero•Montreal, QC

2d•Remote

About The Position

The Clinical Operations Manager is responsible for the day-to-day management of an assigned team of both permanent and contracted staff (e.g., Clinical Research Associates (CRA)/(cCRA)) and other Clinical Operations Support personnel) overseeing their performance and training, ensuring adequate monitoring and support team resources, allocating resources to projects, identifying quality issues related to Clinical Operations activities and establishing action plans to address them. This role will be perfect for you if: You thrive in leading and developing teams, bringing a strong ability to coach, mentor, and drive performance while fostering a collaborative, accountable, and high-quality Clinical Operations environment. You are highly operational and quality-driven, with solid experience in clinical monitoring and a proven ability to manage resources, track metrics, resolve issues proactively, and ensure compliance with SOPs, GCP, and regulatory requirements. You embrace innovation and continuous improvement, demonstrating agility in fast-paced environments, leveraging technology and AI tools to optimize processes, and confidently driving change across cross-functional teams.

Requirements

Bachelor’s Degree in a field relevant to clinical research
Minimum of 6 years of experience in clinical research in the biotechnology, pharmaceutical, or CRO industry, with at least 4 years of relevant experience as a Sr. CRA, or at least 2 years as a Project Manager, Clinical Trial Manager, or equivalent job role
Good experience in the field of monitoring
Experience in a CRO is an asset
Excellent mastery of Microsoft Office suite (Word, Excel, Power Point)
Ability to work in a fast-paced evolving environment and establish good relationships with colleagues and sponsors
Ability to liaise successfully with clinical project teams and other departments
Quick learner, good adaptability and versatile
Demonstrated interest and proficiency in innovation, digital transformation, and operational process optimization within clinical research
Comfortable using AI-powered tools and productivity platforms (e.g., ChatGPT, Microsoft Copilot, Gemini, or similar technologies) to support daily work activities and improve efficiency.
Comfortable working in evolving environments and adapting to new technologies, systems, and industry practices
Proven ability to lead change management initiatives and influence cross-functional teams
Excellent leadership, judgement, and problem-solving skills
Strong organizational, communication, time management and multi-tasking skills
Travel up to 20% of the time
Good knowledge of good clinical practices, applicable Health Canada, Food and Drug Administration (FDA), European Medicines Agency (EMA) regulations/guidelines and other applicable regulatory requirements.
Excellent communication skills (oral and written) in English

Nice To Haves

Experience in a CRO is an asset

Responsibilities

Ensure that clinical monitoring activities of their assigned team are performed to the Sponsor’s satisfaction, ensuring timely quality deliverables, within budget, and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices, and study-specific requirements.
Oversee the performance of their direct reports, ensuring they are meeting performance objectives and taking appropriate remedial actions as required. Implement professional development and performance evaluations.
Support the training and development of Clinical Operations personnel within their remit, providing coaching and mentoring. Ensure team members’ consistent use of study tools and training materials.
Assist in developing and delivering training for Clinical Operations personnel.
Track Clinical Operations metrics and monitor adherence to targets (e.g., number of site visits performed, utilization, and timeliness to complete deliverables such as site visit report finalization, follow-up letters, timesheets, expense reports and required training.)
Ensure monitoring expenses are compliant with policy and aligned with established guidelines.
Perform Quality Assessment Visits (QAV) with CRAs.
Identify quality issues related to Clinical Operations activities through project meetings, site and team communications, site visit reports and follow-up letters, QAVs, and quality assurance audit findings. Summarize findings and establish action plans to bring corrective actions.
Serve as a point of contact for Clinical Operations personnel and other team members for assigned projects or initiatives.
Serve as a management contact for sites, project teams, and sponsors when issues related to Clinical Operations and trial management activities must be escalated to ensure communication is maintained and resolution is achieved.
Assist with assessing and interviewing potential Clinical Operations candidates.
Drive innovation within Clinical Operations by identifying opportunities to optimize workflows and enhance efficiency, quality, and scalability, while supporting the adoption of emerging technologies and AI-enabled solutions to improve study execution.
Foster a culture of innovation, collaboration, and proactive problem-solving across Clinical Operations teams.
May conduct on-site or remote monitoring visits to offer support to project teams.
May perform site visit report review and track site visit report metrics to ensure compliance.
May review or provide input to Clinical Operations plans and tools.
May review and provide feedback on related SOPs and Tools during updates.
May support site survey activities to assess site satisfaction and synthesize insights in support of continuous improvement.
Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training.