DescriptionThe 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.
This role will be perfect for you if:
- You enjoy leading, coaching, and developing Clinical Operations professionals, while creating a collaborative and accountable team environment.
- You are hands-on and quality-driven, and enjoy balancing resource management, clinical monitoring oversight, metrics, compliance, and proactive problem-solving.
- You thrive in a fast-paced, evolving CRO environment where you can bring new ideas, embrace technology and AI, and continuously improve the way Clinical Operations works.
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, good 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;
- 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.
In this position, you will be eligible for the following perks: - Permanent full-time position
- Vacation, benefits, health allowance
- RRSP or 401K
- Yearly bonus structure %
- Home-based position with teleworking allowance
- Ongoing learning and development
Work locationThis position is opened to candidates across Canada or the United States (home-based position).Recruitment process: what to expect- As part of the recruitment process for this position you will meet various team members at Indero
- The first interview will be conducted by Teams (30 minutes) and the second via video conference (1 hour)
- The second interview includes a short presentation for which reasonable advance preparation is required (preparation is not timed and can be completed over a few days). You may think of it as one interview question for which you have the opportunity to develop a strong structured response that goes beyond the surface.
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.
