21 Oct
|
Indero
|
Winnipeg
## Senior Clinical Operations Manager, Canada/USA, remoteCanada (remote)
· Permanent
· Manager#### About The PositionThe Senior Clinical Operations Manager (Sr. COM) is responsible for line management and performance oversight of Clinical Operations personnel, including Clinical Research Associates (CRAs), Clinical Trial Managers (CTMs), and other Clinical Operations roles. The Sr. COM ensures the delivery of high-quality, compliant, and efficient clinical monitoring and trial management services. This role provides strategic oversight, coaching, escalation support, and quality governance. The Sr. COM is also accountable for driving innovation, continuous improvement, and the adoption of technology, automation, and AI-enabled solutions.
We are seeking an experienced Clinical Trial Manager leader who is passionate about developing high-performing CTMs, driving clinical trial management excellence, and advancing innovative approaches to study delivery.This role will be perfect for you if:
* You are an experienced Clinical Trial Manager who is passionate about leading, coaching, and developing CTMs, fostering a culture of accountability, collaboration, and clinical trial management excellence.
* You enjoy driving trial delivery through strategic oversight of study execution, quality indicators, operational KPIs, resource planning, risk management, and proactive problem-solving across a portfolio of studies.
* You are excited by innovation and actively seek opportunities to leverage technology, automation, and AI-powered tools to improve CTM productivity, strengthen oversight, enhance decision-making, and advance the Clinical Operations function.RESPONSIBILITIESMore specifically, the Senior Clinical Operations Manager must:More specifically, the Clinical Operations Manager must:
* Ensure that clinical monitoring and trial management activities of their assigned teams are performed to the Sponsor’s satisfaction, ensuring timely high-quality deliverables, within budget, and in accordance with applicable standard operating procedures (SOPs), regulations, valuable clinical practices, and study-specific requirements.
* Provide line management and performance oversight for Clinical Operations personnel, including Clinical Research Associates (CRAs), Clinical Trial Managers (CTMs), and other roles, ensuring they meet performance objectives aligned with departmental goals, study requirements, and company strategy, and taking appropriate remedial actions as required.
* Support the hiring, onboarding, training, development, retention, and succession planning of Clinical Operations personnel, providing coaching and mentorship.
* Assist in developing, delivering, and overseeing training programs and ensure consistent adoption of SOPs, tools, and systems.
* Oversee resource planning and allocation across studies to ensure appropriate staffing and workload balance.
* Track Clinical Operations metrics and monitor adherence to targets, including performance trends and capacity planning.
* Ensure Clinical Operations activities are executed in accordance with approved study budgets and monitor utilization and financial performance.
* Partner with Project Management and Finance to identify risks and implement mitigation strategies.
* Perform or oversee Quality Assessment Visits (QAVs) and site visit report reviews.
* Identify risks and quality issues and ensure implementation of corrective and preventive actions.
* Serve as escalation point for Clinical Operations teams, sponsors, and stakeholders·
Drive innovation and continuous improvement, including adoption of technology and AI-enabled solutions.
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.#### RequirementsEducation* Bachelor’s Degree in a field relevant to clinical research.Experience* Minimum 10 years of clinical research experience in the biotechnology, pharmaceutical, or CRO industry, including monitoring and senior operational oversight as a Clinical Operations Manager, Project Manager, Clinical Trial manager, or equivalent job role.
* Good experience in the field of monitoring.
* Experience in a CRO is an asset.Knowledge and skills* Excellent oral and written English skills;
* 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;
* Comf
📌 Senior Clinical Operations Manager, Canada/USA, remote Canada (Winnipeg)
🏢 Indero
📍 Winnipeg