Senior Clinical Operations Manager

This is a fully remote position, open to applicants in United States, +1 more country.

📋 Description

• Provide leadership and performance management for Clinical Operations staff, including CRAs, CTMs, and other positions.

• Ensure that clinical monitoring and trial management activities align with sponsor expectations, timelines, budgets, SOPs, regulations, GCP, and study requirements.

• Assist in the recruitment, onboarding, training, development, retention, and succession planning of personnel.

• Mentor and coach Clinical Operations staff.

• Create, deliver, and manage training programs.

• Ensure the integration of SOPs, tools, and systems.

• Oversee resource planning and allocation for various studies.

• Monitor Clinical Operations metrics, performance trends, targets, and capacity planning.

• Supervise study budget usage and financial performance.

• Collaborate with Project Management and Finance on risk assessment and mitigation strategies.

• Conduct or oversee Quality Assessment Visits and review site visit reports.

• Identify risks and quality concerns, implementing corrective and preventive measures.

• Act as an escalation point for teams, sponsors, and stakeholders.

• Promote innovation, continuous improvement, and the adoption of technology, automation, and AI-enabled solutions.

• Execute other assigned responsibilities as qualified and trained.

⛳️ Requirements

• Bachelor’s Degree in a relevant field related to clinical research.

• At least 10 years of experience in clinical research within the biotechnology, pharmaceutical, or CRO sectors.

• Background in monitoring and senior operational management as a Clinical Operations Manager, Project Manager, Clinical Trial Manager, or similar role.

• Strong experience in the monitoring field.

• Experience in a CRO is advantageous.

• Exceptional oral and written communication skills in English.

• Proficient in Microsoft Office suite (Word, Excel, Power Point).

• Ability to thrive in a fast-paced environment and cultivate strong relationships with colleagues and sponsors.

• Capable of effectively liaising with clinical project teams and other departments.

• Demonstrated interest and skill in innovation, digital transformation, and operational process enhancement within clinical research.

• Comfortable utilizing AI-powered tools and productivity platforms (e.g., ChatGPT, Microsoft Copilot, Gemini, or similar technologies).

• Adaptable to new technologies, systems, and industry practices.

• Proven track record of leading change management initiatives and influencing cross-functional teams.

• Strong leadership, judgment, and problem-solving abilities.

• Excellent organizational, communication, time management, and multitasking skills.

• Willingness to travel up to 20% of the time.

• Solid understanding of good clinical practices and relevant Health Canada, FDA, EMA, and other regulatory standards.

• Legally authorized to work in Canada or the United States.

🏝️ Benefits

• Vacation, benefits, and health allowance.

• RRSP or 401K.

• Annual bonus structure %.

• Home-based role with a teleworking allowance.

• Opportunities for ongoing learning and development.

• Permanent full-time position.