Country Study Start Up Specialist

This is a fully remote position, open to applicants in Canada.

📋 Description

• Lead and implement start-up and maintenance activities and deliverables for assigned studies and sites.

• Ensure the timely and high-quality execution of start-up and maintenance tasks.

• Serve as a site start-up expert and offer subject matter expertise support.

• Develop country/site activation plans, set priorities, conduct risk assessments, and create mitigation strategies.

• Identify delivery challenges and communicate proposed solutions.

• Participate in regional/area start-up meetings and contribute insights.

• Gather essential site documentation and perform ALCOA quality checks.

• Prepare and submit ethics and local regulatory submissions, including tailored ICFs, patient-facing materials, and safety reports.

• Coordinate with Regulatory and CMS for Competent Authority submissions and approvals.

• Work closely with contract managers, CRAs, and CSM leads to ensure prompt site activation.

• Review site and IRB/EC feedback on ICFs and route them for functional approval.

• Manage clinical supply shipments effectively.

• Complete investigational product release processes and initiate IP shipments.

• Issue site green-light letters and activate sites in IXRS.

• Monitor start-up and maintenance activities within Vault Study Start-Up.

• Maintain country/site intelligence databases and Expected Document Lists in Vault.

• Track performance metrics and KPIs for designated sites and studies.

• Provide start-up updates and metrics to operations and SSU/CSM leads.

• Ensure readiness for audits and inspections.

• Uphold compliance with corporate and divisional policies, global regulations, and guidelines.

• Lead process improvement efforts to enhance site start-up efficiency.

• Act as an SSU subject matter expert, providing training and mentorship to Country Start-Up Specialists.

• Drive change management initiatives for new technologies and processes.

• Act as area lead for single-country studies.

⛳️ Requirements

• Bachelor's degree in Health Care or Science is highly preferred.

• Minimum of three years of experience in clinical research.

• Preferably over two years of study start-up management experience in the designated region.

• Practical experience interpreting regional clinical research regulations and processes.

• Experience collaborating with central and local IRB/EC sites, including reviewing site and IRB/EC comments on ICFs and routing for approval.

• Familiarity with Vault SSU for essential document processing, IP release, and ICF IRB/EC review.

• Experience working with remote or virtual teams.

• Strong analytical and critical thinking abilities.

• Capacity to evaluate complex issues from various perspectives and facilitate decision-making.

• Excellent interpersonal skills with the ability to build trust and communicate clearly, flexibly, and adaptively.

• Proven success in executing start-up tasks and managing multiple priorities in a fast-paced environment.

• Demonstrated track record of leading successful initiatives, special projects, and activities that support business objectives.

• Working knowledge of ICH and GCP guidelines.

• Operational understanding of the regulatory environment in the country.

• Must occasionally attend training sessions at the head office in St-Laurent, Quebec.

• Proficiency in both French and English, both spoken and written.

• Advanced English knowledge/fluency is a crucial requirement.

🏝️ Benefits

• Innovative work culture.

• Opportunities for professional development.

• Paid time off, including vacation, holidays, personal days, and volunteer days.

• Employee stock purchase plan.

• Wellness spending account.

• Flexible health insurance options.

• Retirement savings programs.

• Bonus plan.

• Remote work arrangement.

• Equal opportunity employer dedicated to integrity, innovation, transforming lives, and serving the community.