Senior Study Start-Up Specialist

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Study Start-Up Specialist based in Canada. This role is responsible for driving high-quality study start-up activities across clinical research programs. You will coordinate site activation from selection through initiation, helping keep studies on track and within established timelines. The position combines regulatory submissions, document management, site engagement, and clinical systems expertise. You will work closely with cross-functional teams and site partners to streamline processes and reduce start-up cycle times. The role also contributes to improving study start-up infrastructure, workflows, and operational efficiency across North America. Success requires strong attention to detail, sound knowledge of clinical research regulations, and effective stakeholder communication. This is an opportunity to contribute to clinical development in a collaborative, fast-moving, and purpose-driven environment.

Lead and coordinate study start-up activities from site selection through activation, including kick-off activities, task completion, and timeline input. Contribute to site feasibility discussions and support informed site-selection decisions. Manage initial and ongoing submissions while ensuring activities are delivered accurately, on time, and in accordance with ICH/GCP, applicable regulations, and standard operating procedures. Prepare and submit documentation to central IRBs and support timely review and approval. Coordinate the preparation, collection, review, negotiation, and management of essential study documents. Build on existing site relationships and partnership data to improve start-up efficiency and reduce cycle times. Maintain accurate study start-up information in the CTMS and ensure timely, high-quality eTMF filing. Support the development of local workflows and process improvements that strengthen study start-up deliverables. Contribute to the continuous improvement of study start-up infrastructure across North America. Take on additional responsibilities as needed to support project, functional, departmental, and organizational objectives. Requirements Bachelor’s degree or higher in a scientific, healthcare, or related discipline preferred. At least 3 years of progressive experience in clinical research and clinical operations. Experience within biotechnology, pharmaceutical, CRO, or clinical-site environments is preferred. Strong working knowledge of ICH/GCP requirements, relevant country regulations and guidelines, and clinical research SOPs. Demonstrated experience with study start-up, site activation, regulatory submissions, essential document management, and/or clinical trial documentation. Familiarity with CTMS and eTMF systems and confidence working with clinical research technologies. Strong organizational and time-management skills, with the ability to manage multiple priorities and meet demanding timelines. Analytical thinking, attention to detail, initiative, and a results-oriented approach. Clear communication skills and the ability to foster effective relationships with internal stakeholders and clinical site partners. A collaborative mindset, adaptability, continuous-learning orientation, and willingness to embrace process and operational change. Benefits Salary: CAD 76,000–95,000 per year. Work arrangement: Fully remote position within Canada. Employment: Full-time opportunity. Opportunity to contribute to clinical research and the advancement of new treatments. Collaborative, cross-functional working environment with opportunities to support process improvement and operational innovation. Exposure to study start-up activities across North America and a broad clinical research environment. Equal-opportunity employment based on qualifications, merit, and business needs.

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