Clinical Operations Specialist (Sponsor Dedicated) – Remote, Canada (Bilingual English/French) Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, 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 a team to help our customers achieve 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 future colleagues already know: Why Syneos Health - We are passionate about developing our people, through career development and progression; supportive and engaged 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 each day and shape solutions that have the ability to dramatically impact someone’s life. - We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job Responsibilities Clinical Operations Specialist (Sponsor Dedicated) – Remote, Canada (Bilingual English/French) Drive Clinical Research Forward. Make an Impact Across Canada. Are you a bilingual Clinical Operations professional with deep expertise in Health Canada regulatory submissions and clinical trial operations? Do you thrive in a fast-paced environment where organization, compliance, and collaboration are critical to study success? We're seeking an experienced 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 excellence. If you're passionate about clinical research and enjoy working behind the scenes to keep studies moving forward, 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+ active protocols). Processing clinical trial invoices accurately and efficiently. Tracking study documentation, regulatory milestones, and operational deliverables. Working cross-functionally with clinical operations, regulatory, and study teams to ensure timely study execution. Maintaining accurate records within study systems and databases Supporting study start-up, maintenance, and closeout activities while ensuring adherence to sponsor processes and regulatory requirements. What We're Looking For Required Qualifications Fluency 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 Board (REB) and/or Institutional Review Board (IRB) submissions. Hands-on experience completing Clinical Trial Site Information (CTSI) forms. Experience processing clinical trial invoices Ability to successfully manage 15 or more concurrent 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 professional 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 collaborative Sponsor Dedicated team supporting innovative clinical research that has the potential to improve patient lives around the world. We offer: Fully remote work within Canada Opportunity to support a leading global pharmaceutical program Collaborative, supportive team environment Meaningful work that directly contributes to advancing clinical research Professional growth and development opportunities If you're a bilingual clinical operations professional who excels in regulatory submissions and enjoys managing complex clinical studies, we encourage you to apply today. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all 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 quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The 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 Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing 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 comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Discover what our Syneos Health colleagues already know: work here matters everywhere. Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers’ delivery of important therapies to patients. We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans. Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you'll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities. We’re a growing, global company dedicated to advancing our talent past their initial role. Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer secures a career in which you’re guaranteed to: Partner with the most diverse team of experts in the industry. From the top down, our people are inspiring. Everyone has a voice and is encouraged to use it. Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration. We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams. With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment and patient population. We are partners with purpose. We integrate seamlessly with our customers and do what’s best for their success. Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.