Join our Talent Pool - Clinical Operations Lead (Canada)
WFA Digital Insight
The demand for skilled clinical operations professionals has grown significantly, with a 25% increase in remote clinical trials in the past year. Alimentiv is at the forefront of this trend, seeking talented individuals to join their team as Clinical Operations Leads. With the rise of digital health, this role offers a unique opportunity to leverage digital skills in a remote setting, overseeing complex clinical trials and ensuring compliance with global regulations. As the industry continues to evolve, professionals with experience in clinical operations, remote work, and digital skills are in high demand. Before applying, candidates should be aware of the importance of staying up-to-date with the latest developments in clinical trials and digital health, as well as the need for strong leadership and communication skills in this role.
Job Description
About the Role
The Clinical Operations Lead role at Alimentiv is a critical position that oversees the execution of clinical trials, ensuring compliance with study protocols, regulations, and timelines. As a Clinical Operations Lead, you will be responsible for leading and supporting monitoring activities, managing site and country performance, and serving as a liaison between CRAs, project teams, and sponsors. This role requires strong leadership and communication skills, as well as the ability to work effectively in a remote setting.The Clinical Operations Lead will be part of a team that is dedicated to delivering high-quality clinical trials, and will have the opportunity to work on a variety of studies across different therapeutic areas. This role is ideal for individuals who are passionate about clinical research, have experience in clinical operations, and are looking to advance their career in a remote setting.
What You Will Do
- Provide overall oversight of regional CRAs to ensure site compliance with study protocols, ICH-GCP, local regulations, and project timelines
- Lead and support monitoring activities, including co-monitoring visits and quality review of monitoring reports
- Actively manage site, country, and regional performance, escalating risks and issues as needed
- Serve as the primary operational liaison between CRAs, project teams, and sponsors, delivering regular status updates and guidance
- Train, mentor, and support CRAs on study-specific procedures, expectations, and performance standards
- Oversee study startup, feasibility, and site management activities, including temporary direct site oversight when required
- Contribute to project planning, financial oversight, and vendor coordination as applicable
- Develop and deliver key study documents, tools, and presentations for sponsors, investigators, and study teams
- Collaborate with cross-functional teams to ensure successful study execution
- Participate in process improvement initiatives to optimize clinical operations
What We Are Looking For
- Minimum 1 year of experience in clinical operations, with an Honours Bachelor Degree
- Experience in managing and leading teams, with strong leadership and communication skills
- Knowledge of ICH-GCP, local regulations, and clinical trial protocols
- Experience with study management systems and electronic data capture systems
- Strong analytical and problem-solving skills, with the ability to escalate risks and issues as needed
- Ability to work effectively in a remote setting, with strong time management and organizational skills
- Experience with budgeting and financial management, with the ability to contribute to project planning and vendor coordination
- Strong attention to detail, with the ability to deliver high-quality results in a fast-paced environment
Nice to Have
- Experience with clinical trial management systems and clinical data management systems
- Knowledge of regulatory requirements and guidelines, with experience in auditing and inspecting clinical trials
- Experience in mentoring and training junior staff, with strong leadership and communication skills
- Certification in clinical research or a related field, such as CCRA or CCRC
Benefits and Perks
- Competitive salary and bonus structure
- Comprehensive benefits package, including health, dental, and vision insurance
- Retirement savings plan, with employer matching
- Paid time off and holiday package
- Opportunity to work on a variety of studies across different therapeutic areas
- Collaborative and dynamic work environment, with a team of experienced professionals
- Professional development opportunities, with training and education programs
- Flexible work arrangements, with the ability to work remotely
How to Stand Out
- To stand out as a candidate, be sure to highlight your experience in clinical operations, particularly in managing and leading teams, and your knowledge of ICH-GCP and local regulations.
- Develop a strong understanding of study management systems and electronic data capture systems, and be prepared to discuss your experience with these tools.
- When applying, be sure to tailor your resume and cover letter to the specific job requirements, and be prepared to discuss your skills and experience in detail.
- Be prepared to discuss your experience with budgeting and financial management, and your ability to contribute to project planning and vendor coordination.
- Consider obtaining certification in clinical research or a related field, such as CCRA or CCRC, to demonstrate your expertise and commitment to the field.
- Research the company and the role thoroughly, and be prepared to discuss your knowledge of the company and the industry.
- During the interview, be sure to ask questions about the company culture, the team you will be working with, and the opportunities for professional development and growth.
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