About Company
Are you ready to shape the future of clinical research? At Hiring.zycto, we are at the forefront of pharmaceutical innovation, dedicated to bringing groundbreaking therapies to patients worldwide. For a Clinical Operations Manager, this means an unparalleled opportunity to lead complex studies, optimize operational efficiencies, and directly impact drug development pipelines. We foster a collaborative, results-driven environment where your strategic vision and leadership skills will thrive, propelling both your career and our mission forward. Join us in making a tangible difference in global health.
Job Description
Hiring.zycto is actively seeking an experienced and dynamic Clinical Operations Manager to join our growing team in York, Toronto. This pivotal role will be instrumental in overseeing the operational planning, execution, and successful delivery of our clinical trials across various therapeutic areas. As a Clinical Operations Manager, you will be responsible for ensuring that all clinical studies are conducted in accordance with Good Clinical Practice (GCP) guidelines, regulatory requirements, and our internal Standard Operating Procedures (SOPs). You will lead cross-functional teams, manage vendor relationships, and drive strategic initiatives to enhance clinical trial efficiency and quality.
This position demands a leader with a strong scientific background, exceptional project management skills, and a proven track record in pharmaceutical clinical operations. You will be the central point of contact for assigned clinical studies, providing expert guidance, resolving complex operational challenges, and fostering a culture of continuous improvement. The ideal candidate will be adept at risk management, budget oversight, and developing robust mitigation strategies to ensure study milestones are met on time and within budget. If you are passionate about advancing medical science and possess the leadership acumen to drive successful clinical programs, we invite you to contribute your expertise to a company committed to patient well-being.
Key Responsibilities
- Lead the planning, execution, and close-out of assigned clinical trials in accordance with GCP, regulatory requirements, and company SOPs.
- Develop and manage clinical trial budgets, timelines, and resource allocation to ensure studies are completed efficiently and effectively.
- Oversee the selection, qualification, and management of Contract Research Organizations (CROs) and other third-party vendors.
- Manage study-related documentation, including protocols, informed consent forms, CRFs, and clinical study reports.
- Monitor study progress, identify potential risks, and implement proactive mitigation strategies.
- Ensure timely and accurate data collection, review, and reporting, collaborating closely with data management and biostatistics teams.
- Lead and mentor clinical trial teams, fostering a collaborative and high-performance work environment.
- Conduct co-monitoring or site visits as needed to ensure quality and compliance.
- Participate in the development and review of departmental SOPs and best practices.
- Prepare and present regular updates on study status, key performance indicators, and operational challenges to senior management.
Required Skills
- Bachelor's degree in a life science or related field.
- Minimum of 7 years of experience in clinical research, with at least 3 years in a clinical operations management role within the pharmaceutical or biotechnology industry.
- Thorough understanding of ICH GCP guidelines, Health Canada regulations, and other relevant regulatory requirements.
- Demonstrated experience managing complex clinical trials from study start-up to close-out.
- Strong project management skills, including budgeting, timeline management, and risk assessment.
- Excellent leadership, communication, and interpersonal skills.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to work independently and collaboratively in a fast-paced environment.
Preferred Qualifications
- Master's degree or Ph.D. in a scientific discipline.
- Professional certification in clinical research (e.g., CCRP, PMP).
- Experience across multiple therapeutic areas.
- Experience with global clinical trials.
Perks & Benefits
- Comprehensive health, dental, and vision insurance.
- Generous paid time off and holidays.
- Retirement savings plan with company match.
- Opportunities for professional development and career growth.
- Dynamic and collaborative work environment.
- On-site fitness center and wellness programs.
- Access to innovative technologies and cutting-edge research.
How to Apply
Ready to make a significant impact on global health? We encourage all qualified candidates to apply. Please click on the application link below to submit your resume and cover letter, detailing your experience and why you are the ideal candidate for this role. We look forward to reviewing your application!