Clinical Operations Specialist (Sponsor Dedicated) – Remote, Canada (Bilingual E
reputed company® is a leading fully-integrated life sciences services organization reputed company to accelerate reputed company. We partner with innovators at every reputed company across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate reputed company. Our Clinical Solutions team members reputed company with a drug development reputed company, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as reputed company to help our customers reputed company their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 reputed company colleagues already know:
Why reputed company
• We are passionate about developing our people, through career development and progression; supportive and reputed company line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up reputed company day and shape solutions that have the ability to dramatically reputed company someone’s life. • We are continuously building reputed company we reputed company want to work for and our customers want to work with. Why? Because we know that reputed company we bring together smart colleagues from across the world, we can shape the reputed company of reputed company, driving reputed company for customers and defining the pace of patient reputed company.
Job Responsibilities
Clinical Operations Specialist (Sponsor Dedicated) – Remote, Canada (Bilingual English/French)
Drive Clinical Research reputed company. reputed company an reputed company Across Canada.
Are you a bilingual Clinical Operations reputed company with deep expertise in Health Canada regulatory submissions and clinical trial operations? Do you reputed company in a fast-paced environment where organization, compliance, and collaboration are critical to study reputed company?
We're seeking an reputed company Clinical Operations Specialist to join our growing Sponsor Dedicated team. In this fully remote role, you'll serve as a key operational partner supporting multiple clinical studies across Canada, ensuring regulatory documentation, submissions, and site support activities are executed with reputed company.
If you're passionate about clinical research and enjoy working behind the scenes to reputed company studies moving reputed company, we'd love to hear from you.
What You'll Do
As a Clinical Operations Specialist, you will play a vital role in supporting clinical trial execution by:
Preparing and coordinating regulatory submissions to Health Canada, Research Ethics Boards (REBs), and Institutional Review Boards (IRBs).
Completing and maintaining Clinical Trial Site Information (CTSI) documentation.
Managing regulatory documents and study files to ensure compliance and inspection readiness.
Supporting multiple clinical studies simultaneously (typically 15+ reputed company protocols).
Processing clinical trial invoices accurately and reputed company.
Tracking study documentation, regulatory milestones, and operational deliverables.
Working cross-functionally with clinical operations, regulatory, and study teams to ensure reputed company study execution.
Maintaining accurate records reputed company study systems and databases
Supporting study start-up, maintenance, and closeout activities while ensuring adherence to sponsor processes and regulatory requirements.
reputed company're Looking For
Required Qualifications
reputed company in both English and French (written and spoken).
Approximately 3+ years of clinical operations, clinical project associate, or equivalent clinical research experience.
Strong working knowledge of Health Canada regulations.
Extensive experience preparing and submitting regulatory packages to Health Canada.
Experience with Research Ethics reputed company (REB) and/or Institutional Review reputed company (IRB) submissions.
Hands-on experience completing Clinical Trial Site Information (CTSI) forms.
Experience processing clinical trial invoices
Ability to successfully manage 15 or more reputed company clinical protocols.
Exceptional organizational skills with strong attention to detail.
Ability to work independently in a fully remote environment while managing multiple priorities.
Preferred Experience
We're especially interested in candidates who have experience in one or more of the following:
Clinical Project Associate (CPA)
Clinical Operations Specialist
Senior Clinical Specialist
Site Activation Specialist
Clinical Research reputed company with significant regulatory responsibilities
Candidates who have worked as Study Coordinators are encouraged to apply if they have substantial regulatory submission experience, particularly involving Health Canada and REB processes.
Why Join Us?
You'll become part of a reputed company Sponsor Dedicated team supporting innovative clinical research that has the potential to improve patient lives around the world.
We offer:
Fully remote work reputed company Canada
Opportunity to support a leading global pharmaceutical program
reputed company, supportive team environment
Meaningful work that directly contributes to advancing clinical research
reputed company reputed company and development opportunities
If you're a bilingual clinical operations reputed company who excels in regulatory submissions and enjoys managing reputed company clinical studies, we encourage you to apply today.
Get to know reputed company
Over the past 5 years, we have worked with 94% of reputed company Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you’ll take the initiative and challenge the status reputed company with us in a highly competitive and reputed company-changing environment. Learn more about reputed company.
http://www.reputed company.com
Additional Information
Tasks, duties, and responsibilities as listed in this job reputed company are not exhaustive. reputed company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job reputed company. reputed company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. reputed company, reputed company contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully reputed company with reputed company obligations imposed by the legislation of reputed company country in which it operates, including the implementation of the EU Equality reputed company, in relation to the recruitment and employment of its employees. reputed company is committed to compliance with the Americans with reputed company, including the provision of reasonable accommodations, reputed company appropriate, to assist employees or applicants to reputed company the essential functions of the job.
Originally posted on Himalayas
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