Site Activation Leader

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

📋 Description

• Lead the strategy and execution for site activation of assigned clinical studies.

• Supervise all start-up milestones from feasibility through to site activation.

• Develop and oversee critical path plans for studies, encompassing regulatory and operational activities.

• Identify potential risks, take proactive measures to mitigate delays, and ensure adherence to delivery timelines.

• Facilitate cross-functional problem-solving to address complex activation challenges.

• Mentor and guide team members involved in site activation.

• Serve as a key liaison among project management, start-up teams, and stakeholders.

• Communicate the status of activation, risks, and solutions to internal teams and leadership.

• Collaborate with clinical operations to ensure alignment with study objectives.

• Act as the Study Start-Up (SSU) subject matter expert for designated clients.

• Provide strategic direction and best practices for initiating studies.

• Assist in the development of proposals and bid defense activities.

• Implement standardized processes and best practices across various studies.

• Analyze performance metrics to drive continuous improvement and operational efficiency.

• Ensure compliance with regulatory standards, SOPs, and GCP.

• Contribute to the development of processes, templates, and documentation.

• Utilize CTMS, EDC, IXRS, and TMF systems to enhance workflows.

• Ensure data integrity and maintain accurate documentation across studies.

• Prepare reports, metrics, and insights to support leadership decision-making.

⛳️ Requirements

• 4–7 years of experience in clinical research operations, particularly in site activation leadership.

• Demonstrated experience in managing site activation activities and teams.

• Strong understanding of the clinical trial start-up process and timelines.

• Experience in working with study sites, investigators, and regulatory requirements.

• Bachelor’s degree in Life Sciences, Healthcare, Business, or a related field.

• Additional training in clinical operations or project management is advantageous.

🏝️ Benefits

• Work remotely within a global, collaborative team environment.

• Opportunity to lead complex, high-impact studies across various therapeutic areas.

• Be part of a team dedicated to operational excellence and innovation.