Associate Site Activation Manager

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

📋 Description

• Lead and oversee all necessary site activation, maintenance, and regulatory tasks for designated studies or multi-protocol initiatives.

• Supervise site activation, pre-award/bid defense, and maintenance efforts for assigned projects in accordance with strategic plans and timelines.

• Formulate, execute, and sustain management plans that align with the project scope and work plan.

• Address project-related challenges and facilitate collaboration among Regulatory and Site Activation teams across various regions and countries.

• Draft and evaluate technical and administrative documentation for business development, study initiation, and ongoing maintenance.

• Provide expert regulatory, scientific, and technical assistance for clinical trials and ensure regulatory compliance.

• Guide and manage multi-regional and multi-protocol programs during their start-up and maintenance phases.

• Define regulatory strategies, expectations, submission parameters, and necessary authorizations.

• Identify regulatory obstacles and offer practical solutions for bid processes and site activation strategies.

• Analyze regulatory environments and contribute to the collection, analysis, interpretation, and dissemination of regulatory intelligence.

• Implement operational strategies for sustaining clinical study approvals and authorizations, plus review and negotiate contracts and key documents.

• Collaborate with Quality Management to uphold appropriate quality standards.

• Mentor and coach team members.

• Keep accurate project information in internal systems, particularly CTMS, databases, tracking tools, timelines, and project plans.

• Build long-term relationships with preferred IQVIA clients.

• Conduct presentations and training sessions for clients, colleagues, and professional organizations.

• Engage in monthly study budget planning and reviews.

⛳️ Requirements

• A bachelor's degree in a relevant field is required.

• At least 3 years of clinical research experience, including a minimum of 1 year in a leadership position, or a suitable combination of education, training, and experience.

• Comprehensive understanding of clinical systems, procedures, and corporate standards.

• Strong grasp of medical terminology and regulatory requirements.

• Extensive knowledge of clinical research.

• Proficient in Microsoft Office and email applications.

• Excellent communication, organizational, interpersonal, presentation, and leadership abilities.

• Capacity to work independently and effectively prioritize tasks.

• Ability to delegate responsibilities.

• Capability to manage multiple projects at once.

• Keen attention to detail.

• Skill in establishing and maintaining effective working relationships with coworkers, managers, and clients.

• Must reside in Canada, specifically in the same country/sales region where the position is located.

🏝️ Benefits

• Incentive plans, bonuses, and/or other compensation options may be available.

• Health and wellness benefits.

• Additional benefits.

• Opportunity for remote/home-based work arrangements.