Senior Study Start-Up Specialist

Accountabilities

- 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.

How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
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